Quantcast
Channel: MassBio Careers
Viewing all 17099 articles
Browse latest View live

Senior Medical Director (ID:390)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity
ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, is seeking a Senior Medical Director to contribute to the growth of an expanding clinical group at ImmunoGen, Inc. Reporting to the Chief Medical Officer, the Senior Medical Director will provide leadership and expertise in the company’s clinical studies of novel therapeutics in hematologic malignancies. Clinical studies are underway or planned for proprietary ADCs that target cell surface antigens expressed in Non-Hodgkin Lymphoma and Acute Myeloid Leukemia, as well Ovarian and Endometrial Cancers.

The Senior Medical Director will be focused on the design, conduct, and execution of clinical trials, along with data analysis and presentation to support indications in hematologic malignancies. Individual who assumes this position will interact with multiple levels of management within ImmunoGen, external stakeholders in the medical community, and with global regulatory authorities.

  • Provide strategic clinical leadership for our Hematologic Malignancy programs.
  • Provide clinical input to optimize new product development for successful launch into the marketplace and lifecycle management.
  • Responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and NDA documents.
  • Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.
  • Travel, as needed, nationally and internationally.

 

Who You Are

  • MD degree with substantial experience in design and interpretation of clinical trials and a substantial track record of clinical research (in hematology, oncology and/or orphan diseases preferred).
  • At least 3-5 years of active medical or academic practice in hematology/oncology with at least eight plus years relevant experience in the pharmaceutical/biopharmaceutical industry is desired.
  • Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
  • Excellent written and verbal communication skills, as evidenced by a record of publications and public speaking.
  • Track record of success and impact working across many interfaces at a senior level within a complex matrix organization with demonstrated ability to successfully interact with external partners.
  • Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

 


Director, Program Management (ID: 463)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

  • Co-manages a cross-functional project team to ensure development and execution of project plans, alignment of project goals with stated corporate strategy and objectives
  • Negotiates difficult matters to influence policy making bodies
  • Develops tools and mechanisms for monitoring project progress, intervention and problem solving within project team and line managers
  • Drives implementation and management of day-to-day project management procedures; specific communication tools that enhance information exchange; department metrics reporting; project management files/databases
  • Manages the development and execution of project development plans and timelines
  • Facilitates communication across company and engage stakeholders with a solution oriented focus and presents strategies and plans to Sr. and Executive management
  • Liaises with functional areas responsible for the project and provides guidance’s on resolving program challenges
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
  • Facilitates meetings, produce minutes and follow up action items
  • Creates, manages and tracks project timeline and other appropriate metrics
  • Creates, manages, and tracks project timeline and other appropriate metrics
  • Creates, edits and presents project updates as needed
  • Prepares regular status reports and presentations

Who You Are

  • 8-12 years of related industry experience
  • 3-5 years of project management or alliance management experience
  • Minimum BS in scientific discipline. Advanced degree preferred
  • Experience with antibodies or biologics preferred
  • Experience in hematological malignancies preferred
  • Knowledge of team dynamics, structure, roles and responsibilities
  • Demonstrated people management skills
  • Strong influence and intrapersonal skills
  • Excellent meeting management skills
  • Excellent verbal, written and presentation skills

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Director/Senior Director, Drug Product Development (ID: 541)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

ImmunoGen is seeking a Director/Sr. Director to provide commercial strategy input to all internal programs and tactical commercial readiness for mirvetuximab, soravtansine, and launch planning.

  • Provide commercial input to Program Teams, as well as lead the development of brand strategies and commercialization plans for assets.
  • Direct / implement strategic commercial projects to inform asset strategy and clinical development plans.
  • Provide commercial insight and market knowledge to opportunity assessments and asset valuations in support of external growth opportunities.
  • Lead  commercial strategy to develop disease area strategies (tumor type analyses) in the oncology therapeutic area.
  • Develop and communicate strong understanding of treatment protocols, level of unmet needs, potential patient segments, and competitive pipeline in order to identify targeted product concepts with necessary product profiles.
  • Direct / implement strategic commercial projects to inform disease area strategies including market research, and disease area mapping.

Key Responsibilities

  • Active participant in all product therapy and product launch planning teams providing recommendations and insights on optimizing current market position and valuing unmet needs opportunities.
  • Identifies and understands business needs to the extent that data requests are translated into actionable and value-adding market assessments.
  • Recommends commercial strategies including packaging, pricing, expense budgets, profit plans and future development of a specific product.
  • Works closely with R&D and Business Development to identify and evaluate external business opportunities providing an in-depth understanding of value drivers and quantifying their impact.
  • Develops early launch planning activities and early brand plans.
  • Develops best practices process for market assessments pre and post launch.
  • Demonstrates in-depth overall industry understanding by providing insightful interpretations and recommendations based on those secondary research findings.
  • Creates revenue and valuation models that capture key value drivers, overall market size, with category and individual product sales.
  • Works to integrate business intelligence needs into strategic plans to ensure proper timing, budget, and coordination considerations.
  • Performs ad-hoc secondary data requests including gathering information from appropriate source(s) and performing necessary analytics.
  • Revises TPP’s and Integrated Development Plans as necessary.

Who You Are

  • Undergraduate science related degree required, MBA preferred with 7-10 years of pharmaceutical/biotech new product planning experience and/or pharmaceutical global strategic marketing experience, with demonstrated strategic/analytical skills.
  • Experience working with Program Teams and R&D to guide asset development is strongly desired. Proven ability to influence in cross-functional settings is a must.
  • Must be a strong communicator, able to confidently present findings to VPs and SVPs, as well as able to represent the commercial position to senior members within different functions of the organization. Additional desired experience: market research planning, global brand planning, KOLs engagement, strategy consulting, and working in the context of collaboration agreements.
  • The successful candidate will identify key drivers, create and manage sales and marketing programs and the respective program metrics to optimize the valuation of the asset.  He/she will proactively identify business issues, opportunities and information needs.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc.,  ImmunoGen, Inc. shall not owe any fee to the submitting agency.

 

Principal Analytical Associate (ID:461)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity
ImmunoGen is seeking an experienced and talented professional who will join the Analytical & Pharmaceutical Sciences group and play an important role in advancing ImmunoGen’s  key development programs through both early and late-stage development with commercialization of our Antibody Drug Conjugates (ADCs). The Principal Analytical Associate will play a vital role in the development of our ADC products by planning and executing preformulation and formulation studies, accelerated and long term stability studies, all leading to a stable, robust final dosage form. The Pr. Analytical Associate will also play a key role in the department by developing and implementing analytical methods that will be used in the release, stability, and characterization testing of our antibody and ADC products. The Pr. Analytical Associate will be involved in supporting the development of upstream, downstream antibody and ADC manufacturing processes by providing the needed analytical and characterization data required to support these efforts.

Responsibilities include, but not limited to, the following:

  • Design and execute formulation development studies for antibodies, liquid and lyophilized ADC drug products using Design of Experiments (DoE).
  • Develop, optimize, and qualify analytical methods for release, stability, and characterization of antibodies, small molecule components, and drug products.
  • Analyze, interpret, and present experimental data to communicate results and continuously improve formulation performance and understanding.
  • Responsible for high quality of documentation, laboratory notebooks, protocols, development reports, tech transfer reports, etc.
  • Interact with departments within  ImmunoGen as well as outside collaborations.
  • Stay current with industry standards and trends.  Evaluate new technologies, procedures, and technical developments.

Who You Are

  • A Bachelor of Science (BS) degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field and 8-10 year related industrial experience is required. Alternatively a Master of Science (MS) degree in the same fields and 6-8 years of related industrial experience is required.

Required:

  • Knowledge and understanding of liquid and lyophilized formulation development.
  • Expertise in the development and performance of chromatographic analytical methods (e.g. RP, SEC and IEX HPLC/UPLC).
  • Experience with biophysical characterization techniques to analyze proteins (e.g. UV and fluorescence spectroscopy, analytical ultracentrifugation, DSC).
  • Enthusiastic, team player with passion for growth and innovation.
  • Excellent oral and written communication skills.
  • Demonstrated technical proficiency and creativity, with proven ability to independently design and execute experiments.
  • Excellent organizational and time management skills.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Principal Research Associate (ID: 601)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

 

The Opportunity

 

ImmunoGen, Inc. is in search of a Principle Research Associate in our Pharmacology and Toxicology Group. The Principle RA will play an integral role in evaluating and advancing research and development programs at ImmunoGen, Inc. This person will work closely with members of different functional groups, and will have the opportunity to have broad exposure and impact across the research and development organization.

 

The responsibilities of the Principle Research Associate include:

 

1.    Perform in vivo studies at Principle RA level- Plans experiments from beginning to end, independently coordinates and schedules all aspects of in vivo studies. (Efficacy, PK, tumor models, tolerability/toxicology). Studies for multiple programs will be performed simultaneously requiring excellent organization, time management and scheduling skills. Presents data at group meetings, writes study memo or reports as needed.

 

2.   Serves as back-up trainer for Research Associates and Scientists- animal handling, procedures (dosing, blood collection,tumor inoculation), use of study director software for study design, data collection,randomization. Data analysis, recordkeeping (proposals/memos) and electronic notebook

 

Who You Are

  • The qualified candidate will have a Bachelor’s Degree in Pharmacology, Biology or a related discipline, and 5+ years of experience in the pharmaceutical industry.
  • Recent graduates will not be considered for this role.
  • Applicants must have unrestricted authorization to work in the United States.
  • Hazardous chemicals/environment; work with rodents; weekend work will be required on occasion

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

QA Training Specialist III (ID: 681)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

The Quality Assurance Training Specialist III is responsible for the development and/or delivery of training programs related to ImmunoGen’s standard operating procedures. The Training Specialist III also provides training support to the Norwood and Waltham facilities internal customers.  The Training Specialist III works with cross functional teams to identify and implement meaningful training metrics that will be used to present to management.

Duties and responsibilities include but are not limited to the following:

  • Executes training program for new and existing employees
  • Generate metrics at the required frequency which drive accountability and delivery of targets
  • Work with Subject Matter Experts (SME’s) to develop training presentations
  • Assists in the delivery and administration of the training curriculums.
  • Assists with coordination of class schedules, sites and materials.
  • Support continuous improvement of current systems, procedures and practices by constructively challenging the current state to ensure consistency across systems
  • Ability to co-lead and motivate cross-functional teams
  • Excellent interpersonal/communication skills
  • Engage with project managers to support CMO activities
  • Revise and approve procedures as required
  • Able to effectively lead team projects to a successful outcome

Who You Are

  • BA/BS Degree
  • 5-8 years of related experience
  • Working knowledge of current Good Manufacturing Practices (cGMP)
  • Proficiency in the use of Adobe Acrobat, Microsoft Office and electronic document management systems
  • Exceptional verbal and written communication skills

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

QA Documentation Specialist (ID: 861)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

This position supports the proper control, maintenance and improvements of the systems and processes associated with the Quality Assurance Document Control Department.  The position creates/ maintains necessary procedures and assists in the configuration / customization of the electronic document management system and provides training to staff members as necessary.  This position requires flexibility with changing priorities.

Duties and responsibilities include but are not limited to the following:

  • Supports various implementation and maintenance activities associated with the company’s electronic document management system.
  • Participates in validation and change activities in conjunction with IT, Validation and stakeholders related to the implementation and on-going support of electronic systems.
  • Creates/maintains procedures, policies and training documentation for the control and use of the systems and processes.
  • Writes/edits procedures in conjunction with subject matter experts on technical subjects in a collaborative manner.
  • Conducts user-training sessions for staff members.
  • Acts as liaison between quality assurance and other functional departments/ external vendors to address various system issues.
  • Evaluates product enhancements and capabilities assisting in recommending and implementing upgrades as required.
  • Supports document lifecycle management for electronic documents in EDMS and the Norwood Archive Room.
  • Reviews documents for grammar, accuracy, and consistency with departmental guidelines.

Who You Are

  • Bachelor's degree in a scientific discipline or a combination of education and equivalent experience
  • Minimum of 5 years of directly related experience in a GMP environment, experience with GLP and/or GCP environments a plus
  • Minimum of 4 years experience with document control systems
  • Strong information management skills including proficiency in database creation and maintenance and understanding of 21 CFR Part 11 compliant systems
  • Proficiency in the use of Adobe Acrobat, Microsoft Office and electronic document management systems
  • Strong organizational and/or project management skills.
  • Solid written and verbal communication skills, experience with technical writing a plus.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. 

Associate Director, Quantitative Bioanalytics Outsourcing, Clinical Pharmacology (ID: 881)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

Reporting to the Head of Clinical Operations, the Director of Clinical Outsourcing and Contracts will be primarily responsible for leading the activities related to outsourcing of clinical services to Clinical Resource Organizations (CROs)  and other service providers for one or more clinical programs in various stages of development.  The successful incumbent will work closely with various internal team members and vendors to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. The Director will also be required to put in place a process providing tools for managing site contracts to ensure Fair Market Value (FMV) and compliance with the company legal process.

Job Responsibilities

CRO & Service Provider Management

  • Manages the Request For Proposal (RFP) process and vendor bidding process for one or more clinical development programs
  • Develops and executes implementation plans to ensure sourcing benefits are fully realized
  • Conducts an ongoing analysis of vendor performance using metrics, expectation requirements and KPIs to ensure compliance of contracted services
  • Proactively identifies potential vendor issues/risks and recommends/implements solutions
  • Leads budget and contract negotiations with Clinical Development service providers including all initial contracts and any change orders
  • Serves as point of contact to the CROs and clinical development vendors in resolving contract scope and budget issues
  • Identifies and maintains lists of potential vendors which may be used for Clinical Development outsourcing
  • Participates in the development, review and implementation of departmental SOPs and processes
  • Recommends and implements innovative process ideas and tools to impact clinical procurement and outsourcing
  • Ensures that expectations within and between the organizations with regard to establishing costs, budgeting and reporting, invoicing, turnaround times, contractual documentation and approach, payment schedules and other business practices are established and managed
  • Collaborates with cross-functional groups to ensure the most optimal strategies and solutions are achieved in alignment with departmental objectives and achieving best value
  • Proactively manage outsourcing contracting activities across functions as appropriate, ensuring adherence to the outsourcing strategy, and company policies and procedures.
  • Oversee collection and archiving of compliance related vendor information and ensures vendor compliance to SOPs and Policies
  • Provides training and communications to internal stakeholders and providers regarding contracting process, sourcing best practices and process improvements

Site Contracts

  • Build a robust process to oversee initiation and execution of all Clinical Trial Agreements (CTAs) with clinical trial sites for the clinical operations organization to achieve study specifications, timelines, and budgets
  • Manage the CRO to ensure contracts are executed in line with ImmunoGen’s guidance and payments made in accordance with the terms in the site agreement(s)
  • Asses tools needed to build budgets using benchmarking; historical data and ensuring Fair Market Value (FMV)
  • Negotiate CDA/CTA language as requested; either requested by CRO or Clinical Operations personnel

Job Qualifications

  • BA/BS in Life Science, Finance, or related field
  • 10+ years pharmaceutical/biotechnology experience
  • 6+ years strategic sourcing / category management / clinical outsourcing experience in Pharma, Biotech and/or CRO
  • Advanced knowledge in: drug development process (Phase I-IV); contract management; provider management and governance/oversight
  • Working knowledge of associated disciplines including Clinical Trials Management /Operations, Clinical Monitoring, Data Management, Safety Reporting, Medical Writing, Regulatory, and Ancillary Vendor Service
  • Demonstrated skills in developing/ setting sourcing strategies, identification of service providers, issuing Requests for Information/Requests for Proposal (RFI/RFP) and performing analysis
  • Broad and deep understanding of Contracts and Outsourcing practices for Global Clinical Trials, including current legal, regulatory, compliance components of the process
  • Ability to provide direction with cross-functional teams in a team environment, collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
  • Ability to manage change successfully and identify process improvements
  • Expert knowledge of contracting and sourcing best practices, industry marketplace
  • Excellent leadership, communication, and influencing skills
  • Demonstrated negotiation skills/ strategies

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.


QC Chemistry Analyst II (ID: 901)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

ImmunoGen, Inc. is in search of an organized, team player to join our Quality Control department in Norwood, MA. This position will support activities related to Quality Control Chemistry testing of raw materials, clinical production, and stability samples. The position will also support general lab duties in compliance with GMPs. This position requires flexibility with changing priorities.

The QC Analyst will work independently to perform Chemistry assays (SEC, RP, HPLC, CE, SDS, USP/EP pharmacopeia assays) in support of clinical production, release and stability program. This position will maintain the laboratory testing area, equipment, and supporting documentation for routine activities. The QC Analyst will have strong interpersonal, written, and verbal communication skills. This position requires active participation in a group environment to support the Quality Control department. In addition, this individual will write and revise SOPs, review data, support analytical method transfer/qualification activities and provide recommendation for improved efficiency of existing laboratory processes.

Job responsibilities include but not limited to the following:

  • Perform routine Chemistry testing (SEC, RP-HPLC, CE, SDS-PAGE)
  • Perform data review
  • Write and revise SOPs
  • Support investigation activities into non-conformances (deviations, Out-out- Trends, Out-of-Specification) and change control
  • Lab maintenance and basic equipment troubleshooting
  • Support analytical transfer/qualification activities (execute and draft protocols/reports)
  • Support continuous improvement of lab processes for increased efficiency

Who You Are

  • Bachelor’s degree in scientific discipline with a minimum of 2-4 years of related experience in GMP environment.
  • Experience with chemistry assays preferred.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

 

Senior CMC Project Manager (ID: 981)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

The Senior CMC Project Manager will have primary responsibility for leading a cross-functional CMC project team(s) along with the Technical/Scientific Lead.  This role will ensure that CMC projects are defined, implemented and closed out in a manner consistent with best project management practices.

The Senior CMC Project Manager will be a member of the overall program team, representing CMC, and will drive the development of comprehensive CMC project plans. This individual will team with the Scientific Technical Lead and other senior leaders in the development and implementation of the CMC project’s strategy and comprehensive project plans.

This role will report directly to the Director, CMC Program and Operations Management, and will sit within the Technical Operations Project Management Office.  He/she will jointly exercise responsibility for the roll-out and implementation of a Project Management Office, which will include training and mentoring CMC sub-team project managers on PMO tools, templates, and modules. The Senior CMC Project Manager will have dotted line responsibilities for the CMC sub-team project managers.

To be successful in this role will require proficient project management skills, communication skills, and soft skills.  The Senior CMC Project Manager must have the ability to collaborate and influence team members and leaders across the company as well as to be able to work in a rapidly changing environment; embrace ambiguity and complexity and demonstrate problem-solving leadership.

Responsibilities to include:

  • The Senior CMC Project Manager will provide leadership for CMC project(s); lead cross-functional teams to ensure that work is well planned and successfully executed on-time and within scope and budget.
  • This role will work closely and communicate effectively with cross-functional teams and leaders from all parts of ImmunoGen to ensure the team is set up to successfully deliver on all project commitments through the implementation and adherence to robust project and risk management practices.
  • In conjunction with the Technical/Scientific Lead and the Project Sponsor:
    • Identifies the project objectives and scope
    • Develops and implements the CMC project’s strategy
    • Identifies measurable success criteria
    • Builds a fully integrated schedule capturing all activities needed to deliver the business objective
    • Ensures that project risk management is in place
    • Develops and implements stakeholder management and communication plans
    • Ensures that project sub-teams apply the techniques stated above to their planning
    • Provide leadership and direction to the CMC sub-teams
  • As part of the PMO, responsible for applying best practice project management techniques.
    • Monitor and report progress of team against milestones, deliverables, identification and management of project issues
    • Adjust project in response to progress, unanticipated delay, and changing business environment
    • Identification of risk areas, monitoring of risk status, and contingency planning
    • Mentor sub-team project managers in the implementation of the PMO best practices
  • Facilitates communication across company and engages stakeholders with a solution oriented focus and presents strategies and plans to senior management and governance forums
  • Ability to run multiple cross-functional teams at a time
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
  • Build and nurture employee engagement by creating environment within which individuals and teams can grow and excel.

Who You Are

  • Bachelor's degree in Science, Engineering or a related field with 7+ years' relevant industry experience in biopharma manufacturing/business; or Master's Degree in Science, Engineering or a related field with 5+ years' relevant industry experience.
  • A minimum of 5 years of project management experience with cross functional team management experience; CMC project management background preferred; late stage commercialization experience a plus; project management certification is a plus
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development is a plus
  • Operating skills including the ability to plan and organize the work to marshall resources and get the work done.
  • High level of personal and professional integrity and trustworthiness with strong work ethic.
  • Strong skills in communication, meeting management, and verbal, written, and presentation skills.
  • Knowledge of team dynamics, structure, roles and responsibilities.
  • Strong ability to embrace ambiguity and complexity and demonstrate problem-solving leadership; ability to translate complex concepts into actionable, measurable tasks.
  • Ability to respond quickly and effectively to changing environments.
  • Demonstrated people management skills. Ability to create effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organization levels.
  • Skilled facilitator and negotiator with a keen eye for detail.
  • Some US and Global travel may be required.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

 

Associate Director Global Oncology Health Economics for ADCETRIS and Early stage assets (NPP)

0
0

The Associate Director Global Oncology Health Economics for ADCETRIS and  pipeline reports to the Senior director GOPMA/HE, and is responsible for leading, developing and continually enhancing best-in-class HE strategies and health economics aspirational value propositions to achieve and/or retain a competitive advantage for Adcetris and Early stage assets (NPP). 

The AD uses his/her oncology payer knowledge and health economics expertise to help shape the evolving pipeline molecules to meet the needs of global payers.  He or she works closely with internal business partners (e.g., country/regional market Access, US, Japan, EU, and Emerging markets, GOR, New product Planning, medical affairs, Development, etc.) to identify and incorporate global payer needs into product strategies. 

DUTIES & RESPONSIBILITIES:

The Associate Director will lead global payer market research projects including, but not limited to understanding the evolving reimbursement landscape, identify payer value drivers, evaluate the resonance/data support of value messages, and identify price corridors. The AD will establish estimates of the global pricing potential and reimbursement strategy for all Takeda Oncology pipeline assets and business development opportunities at each phase of clinical development, including phase 1 assets. The AD will identify, evaluate, prioritize, and gain access to key databases and syndicated reports to help inform the organization about key trends in global pricing and reimbursement.  He/she will provide regular updates about changes to global health systems and market access trends to relevant internal stakeholders. The AD will be  a central expert on HE modeling and may as such work on late stage assets in addition to business development or other as products as needed

 

Essential Functions

  • Develop and prioritize evidentiary requirements for Health Technology Assessment (HTA) and Market Access decision makers
  • Lead the development of economic models with sufficient evidentiary support to withstand critique of HTA bodies and other key access decision makers
  • Engage with key HTA bodies to understand their value drivers and then map them back to economic modeling and evidence collection efforts
  • Highlight evidentiary requirements of HTA bodies and make recommendations to cross functional business partners about the need for registries, databases, etc. to fill evidentiary gaps
  • Lead product-specific cross functional/regional GPMA-HE /GOR teams
  • Partner with Business Unit LOCs and regional Market Access teams to align on payer needs to provide a unified voice to development teams for pipeline products
  • Evaluate relevant HTA decisions and apply key learning’s to pipeline products and possibly marketed products.
  • Build effective business relationships with cross functional/regional business partners and stakeholders (e.g. US Market Access, GOR, NPP, Marketing, Development, Europe, Latin America, Asia, etc.)
  • Coordinate with Outcomes Research and Global and US Market Access Teams for development of cost/value drivers, epidemiology, efficacy, and other information needed to populate models
  • Drive department education on all relevant aspects of HE models

 

Key Objectives/Deliverables:

  • Responsible for providing GPMA-HE support for four to five pipeline products.
  • Partner with cross functional/regional business partners
  • Anticipate payer need to successfully implement P&R strategy.  Influence the development of target product profiles (TPP) and study protocols to reflect payer needs.
  • Include payer needs in key product decisions including, but not limited to: indication selection, indication sequencing, product presentation, and trial design.  Highlight potential payer issues associated with variable dosing across indications and wastage.
  • Clear expert in HE modeling and responsible for creating (with vendors) or model across the assets of responsibilities
  • Fundamental understanding of the oncology drug development process and clinical trial design.
  • Advanced degree (PhD or MS  preferred) with at least 8 years of industry experience with pipeline and marketed products, launch experience strongly preferred
  • Additional Masters or PhD in Economics, Econometrics, or any other related field with 8 years of relevant experience is preferred
  • Background or degree in science a plus.
  • Minimum of 8 years experience with strong methodological, quantitative, and analytical skills
  • Familiarity with commercial and public payers customers in the US (e.g. PBM’s, MCOs, Employers, Medicaid, Managed Medicaid, CMS (Parts B & D), and the complex dynamics among key players affecting the payer customer is a plus.
  • Leadership – strong ability/desire to work in a highly matrixed organization
  • Strong analytical capabilities and excellent communication skills (written and oral)
  • Strategic thinking and demonstrated problem solving capability
  • Influencing skills (one on one and in group setting) – consensus builder with ability to effective drive decision making
  • Ability to translate technical issues to non-technical experts  
  • 20% Domestic and/or International travel

 

PREFERRED QUALIFICATIONS:

  • Previous experience in Hematology and/or Oncology is strongly preferred
  • Prior PMA/HE or equivalent regional or global experience preferred
  • Direct payer experience and/or experience in product commercialization a plus
  • Track record of publications would be a plus

Principal CMC Project Manager (ID: 982)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

The Principal CMC Project Manager will have primary responsibility for leading a cross-functional business critical CMC project team(s) along with the Technical/Scientific Lead.  This role will ensure that CMC projects are defined, implemented and closed out in a manner consistent with best project management practices.

The Principal CMC Project Manager will be a member of the overall program team, representing CMC, and will drive the development of comprehensive CMC project plans. This individual will team with the Scientific Technical Lead and other senior leaders in the development and implementation of the CMC project’s strategy and comprehensive project plans.

This role will report directly to the Director, CMC Program and Operations Management, and will sit within the Technical Operations Project Management Office.  He/she will jointly exercise responsibility for the roll-out and implementation of a Project Management Office, which will include training and mentoring CMC sub-team project managers on PMO tools, templates, and modules. The Principal CMC Project Manager will have dotted line responsibilities for the CMC sub-team project managers.

To be successful in this role will require expert project management skills, communication skills, and soft skills.  The Principal CMC Project Manager must have the ability to collaborate and influence team members and leaders across the company as well as to be able to work in a rapidly changing environment; embrace ambiguity and complexity and demonstrate expert problem-solving leadership with limited direct oversight.

 

Responsibilities to include:

  • The Principal CMC Project Manager will provide leadership for business critical CMC project(s); lead cross-functional teams to ensure that work is well planned and successfully executed on-time and within scope and budget.
  • This role will work closely and communicate effectively with cross-functional teams and leaders from all parts of ImmunoGen to ensure the team is set up to successfully deliver on all project commitments through the implementation and adherence to robust project and risk management practices.
  • In conjunction with the Technical/Scientific Lead and the Project Sponsor:
    • Identifies the project objectives and scope
    • Develops and implements the CMC project’s strategy
    • Identifies measurable success criteria
    • Builds a fully integrated schedule capturing all activities needed to deliver the business objective
    • Ensures that project risk management is in place
    • Develops and implements stakeholder management and communication plans
    • Ensures that project sub-teams apply the techniques stated above to their planning
    • Provide leadership and direction to the CMC sub-teams
  • As part of the PMO, responsible for applying best practice project management techniques.
    • Monitor and report progress of team against milestones, deliverables, identification and management of project issues
    • Adjust project in response to progress, unanticipated delay, and changing business environment
    • Identification of risk areas, monitoring of risk status, and contingency planning
    • Mentor sub-team project managers in the implementation of the PMO best practices
  • Facilitates communication across company and engages stakeholders with a solution oriented focus and presents strategies and plans to senior management and governance forums
  • Ability to run multiple cross-functional teams at a time
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
  • Build and nurture employee engagement by creating environment within which individuals and teams can grow and excel.

 

Who You Are

  • Bachelor's degree in Science, Engineering or a related field with 10+ years' relevant industry experience in biopharma manufacturing/business; or Master's Degree in Science, Engineering or a related field with 8+ years' relevant industry experience.
  • A minimum of 8 years of project management experience with cross functional team management experience; CMC project management background preferred; late stage commercialization experience a plus; project management certification is a plus
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development; experience with antibodies a plus
  • Expert operating skills including the ability to plan and organize the work to marshall resources and get the work done.
  • High level of personal and professional integrity and trustworthiness with strong work ethic.
  • Expert level skills in communication, meeting management, and verbal, written, and presentation skills.
  • Strong knowledge of team dynamics, structure, roles and responsibilities.
  • Excellent ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks.
  • Ability to respond quickly and effectively to changing environments.
  • Demonstrated expert level people management skills. Ability to create effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organization levels.
  • Skilled facilitator and negotiator with a keen eye for detail.
  • Some US and Global travel may be required.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

 

Senior Research Associate, Bioanalytical (ID: 1043)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

ImmunoGen, Inc. of Waltham MA is in search of a Senior Research Associate to join the Bioanalytical Sciences department. The qualified candidate will be responsible for supporting the development and troubleshooting of biochemical/immunoassays and cell-based assays under either GMP or GLP guidelines to support our ADC candidate development. Responsibilities include but are not limited to:

 

  • Develop cell-based cytotoxicity assays and immunoassays potency assays to support early phase drug product release to support ADC drug substance release.
  • Oversee the adaptation of immunoassays onto automated systems, including program/protocol generation, qualification of procedures and consolidation of methods.
  • Perform testing in support of process development, characterization and formulation as well as support product quality testing during cell line development during early phase ADC development.
  • Develop and perform characterization of antibody functions including direct cytotoxicity assays and reporter gene assays to monitor ADCC and ADCP activities to support cell line development, drug substance release and process characterization studies.
  • Work within a multi-disciplinary team environment including groups such as Process Science, Analytical, QC, Discovery and Clinical Pharmacology.
  • Independently write SOPs, technical reports and test methods.
  • Summarize and present data within the team and across various functional team meetings.
  • Minor support of immunoassay development for PK assessments of ADCs.

 

Who You Are

  • BS with 6-8 years of experience or MS with 4-6 years of experience.
  • Strong technical experience with developing and troubleshooting cell based assays, ELISAs and other immunoassay platforms.
  • Expertise in cell culture and can handle multiple cell lines.
  • Routinely performed or implemented automation for immunoassays using liquid handling systems
  • Detailed-oriented with the ability to multitask.
  • Excellent written and verbal communication skills to work in a multi-disciplinary team.
  • Demonstrated application of GMP or GLP requirements to bioassays is not required but considered a plus.

 

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Associate Director Global Oncology Pricing Market Access and Health Economics (GPMA\HE) Early stage assets (NPP)

0
0

POSITION SUMMARY:

The Global Oncology PMA/HE (GOPMA/HE) pipeline Associate Director reports to the Senior director GOPMA/HE, and is responsible for leading, developing and continually enhancing best-in-class market access strategies and health economics aspirational value propositions to achieve and/or retain a competitive advantage for Early stage oncology assets (NPP). 

 

The AD of GPMA-HE (GPMA/HE) uses his/her oncology payer knowledge and health economics expertise to help shape the evolving pipeline molecules to meet the needs of global payers.  He or she works closely with internal business partners (e.g., country/regional market Access, US, Japan, EU, and Emerging markets, GOR, New product Planning, medical affairs, Development, etc.) to identify and incorporate global payer needs into product strategies. 

 

The Oncology GPMA/HE Associate Director is also responsible for department wide operating initiatives (such as support for Business Development assessments etc). The AD will be responsible for leading all GPMA/HE activities for at least three NPP products.  

 

DUTIES & RESPONSIBILITIES:

The Associate Director will lead global payer market research projects including, but not limited to understanding the evolving reimbursement landscape, identify payer value drivers, evaluate the resonance/data support of value messages, and identify price corridors. The AD will establish the reimbursement strategy and estimates of the global pricing potential for Takeda Oncology pipeline assets and business development opportunities at various phases of clinical development, including phase 1 assets. The AD will identify, evaluate, prioritize, and gain access to key databases and syndicated reports to help inform the organization about key trends in global pricing and reimbursement.  He/she will provide regular updates about changes to global health systems and market access trends to relevant internal stakeholders. The AD will manage one or two contractors based on business need.

 

Essential Functions

  • Lead GPMA-HE for the development of market access strategies for early stage oncology products, BD assessments and possibly for one or two products in late stage development
  • Develop and prioritize evidentiary requirements for Health Technology Assessment (HTA) and Market Access decision makers
  • Lead product-specific cross functional/regional GPMA-HE /GOR teams
  • Partner with Business Unit LOCs and regional Market Access teams to align on payer needs to provide a unified voice to development teams for pipeline products
  • Ensure GPMA-HE strategy is aligned with overall product strategy for products under their responsibility.  This includes making recommendations for product strategy, indication selection, sequencing, etc.
  • Anticipate global payer and payer influencer needs to achieve P&R strategy at launch.  Partner with cross functional/regional teams to identify gaps, prioritize needs and make recommendations for changes to development programs and advocate for funding needs. 
  • Evaluate relevant HTA decisions and apply key learning’s to pipeline products and possibly marketed products.
  • Identify, evaluate, prioritize, and gain access to valuable secondary research reports and databases.  Provide regular updates about P&R trends and changes to key healthcare systems.
  • Build effective business relationships with cross functional/regional business partners and stakeholders (e.g. US Market Access, GOR, NPP, Marketing, Development, Europe, Latin America, Asia, etc.)
  • Develop early assessments of the access viability of a product, using a variety of methods and techniques
  • Key Objectives/Deliverables:
  • Responsible for providing GPMA-HE support for four to five oncology pipeline products.
  • Partner with cross functional/regional business partners
  • Anticipate payer need to successfully implement P&R strategy.  Influence the development of target product profiles (TPP) and study protocols to reflect payer needs.
  • Include payer needs in key product decisions including, but not limited to: indication selection, indication sequencing, product presentation, and trial design.  Highlight potential payer issues associated with variable dosing across indications and wastage.

REQUIRED BASIC QUALIFICATIONS:

  • Fundamental understanding of oncology drug development process and clinical trial design.
  • Advanced degree in Science or MBA/MHA or other graduate level program preferred
  • Additional PhD in Economics, Econometrics, or any other related field with 8 years of relevant experience is a plus
  • Minimum of 8 years experience with specialty pharmaceutical reimbursement and access, oncology is a plus.
  • At least 2 years in a global or regional pricing and reimbursement role is strongly preferred.
  • Understanding of key market access decision makers in major European markets.
  • Familiarity with commercial and public payers customers in the US (e.g. PBM’s, MCOs, Employers, Medicaid, Managed Medicaid, CMS (Parts B & D), and the complex dynamics among key players affecting the payer customer is a plus.
  • Familiarity with Asian, Latin American, and CEE markets a plus.
  • Leadership – strong ability/desire to work in a highly matrixed organization
  • Strong analytical capabilities and excellent communication skills (written and oral)
  • Strategic thinking and demonstrated problem solving capability
  • Influencing skills (one on one and in group setting) – consensus builder with ability to effective drive decision making
  • Strong history of delivering high quality, sustainable results using skills and capabilities.  
  • 20% Domestic and/or International travel

 

PREFERRED QUALIFICATIONS:

  • Previous experience in Hematology and/or Oncology is strongly preferred
  • Prior commercial experience with early stage assets (NPP) at regional or global role is preferred

 

  • Direct payer experience and/or experience in product commercialization a plus

Head of Supply Chain Management (ID: 1182)

0
0

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Head of Supply Chain Management will lead those functions with primary responsibility for ensuring the  reliable supply of small molecules and antibody components of ImmunoGen’s ADCs, as well as for the ADCs themselves (both drug substance and drug product) for both clinical and ultimately commercial use. This individual will lead teams / staff responsible for supply chain planning (demand planning, supply planning and materials planning), logistics and distribution (including warehouse / inventory control).

This senior leadership role will report to the VP, Manufacturing Operations and will provide strategic, leadership and direction to the Supply Chain Management organization in alignment with ImmunoGen’s operational and long term objectives.  The Head of Supply Chain Management will work closely with key stakeholders including Manufacturing, Quality, Clinical and Commercial teams to define and build the capabilities required to effectively manage ImmunoGen’s complex global supply chain and support eventual launch and commercialization efforts.

Responsibilities to include:
 

  • Overse staff, suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure customer goals are fulfilled on a timely basis and inventory goals are met.
  • Direct communications with internal customers (Manufacturing, External Manufacturing, QA, QC, Clinical…) regarding supply, demand and scheduling issues through planner.
  • Oversee Clinical Supply staff responsible for coordinating external product finishing, packaging and logistics activities, clinical demand / supply modeling and development, implementation and maintenance of Integrated Response Technologies.
  • Provide oversight for import / export compliance and logistics management between ImmunoGen, suppliers and partners.
  • Work closely with other functions to drive overall supply chain efficiency and product delivery in a cost-efficient manner.
  • Lead the Demand & Operations Planning process as well as cross-functional process improvement initiatives.
  • Drives development of relevant supply chain metrics, data collection and reporting.
  • Ensure appropriate inventory controls and partner with Finance for financial closes and audits.
  • Supports the development of regulatory CMC documentation and partner due diligence.
  • Work with the Supply Chain, Quality and Clinical organizations as necessary to ensure that any excursions, deviations, CAPAs… are initiated, addressed and closed within target timeframes.
  • Establish long range strategic and operating plans and set near-term priorities for the Supply Chain Management organization consistent with ImmunoGen’s Technical Operations strategy and long term objectives.
  • Establish functional priorities and goals and identify performance improvement targets and metrics ensuring capabilities in place to effectively deliver on all commitments and performance targets.
  • Optimize resources by deploying and modelling robust talent development, performance management, and succession planning and rewards/recognition practices.
  • Build and lead high performing team and ensure tight alignment between all functions as well as other corporate functions.
  • Implement appropriate team/departmental structures and governance and establish the required processes and communications to enable the Supply Chain Management organization to deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
  • Build and nurture employee engagement by creating environment within which individuals and teams can grow and excel. Serve as coach/mentor.
  • Prepares annual and multi-year financial budgets and forecasts. Manage headcount and expenses to meet approved spending plans while delivering on commitments.
  • Stay current with current industry standards, new trends and all applicable regulations.
  • Develop and maintain external relationships with subcontractors, and service providers.

 

Job Requirements

  • A minimum of 15 years in biopharmaceutical supply chain management with a minimum of 12 years in leadership roles.
  • Advanced degree in supply chain management, operations management or similar relevant discipline.
  • Proven experience in building supply chain management departments, processes and systems to support biopharmaceutical development and commercialization.
  • Must have strong knowledge of materials management, global logistics, clinical and commercial supply. Experience in cold chain management strongly preferred.  Direct experience with distribution channel development and third party logistics providers strongly preferred.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.


Senior Manager/Associate Director, Validation Engineer

0
0
Overview:
  • Lead efforts in qualifying facilities, equipment and utilities at Alnylam’s manufacturing plants in accordance with established regulations and approved quality standards.
  • Develop and maintain validation program documents including SOPs, Master Plans, Protocols, and Reports for FEU qualification and cleaning validation.
  • Develop organizational budgets or project budgets encompassing for large or complex project.
  • Providing validation support in deviation investigations and change control.
  • Expected to be capable of managing complex project objectives. 
  • Expected to directly supervise staff and project resources.
  • Expected to contribute in regulatory filings and inspections.
Summary of Key Responsibilities:

Will be accountable for validation at Alnylam’s manufacturing facilities and ensuring that facilities are maintained in compliance

Qualifications:
  • Master’s degree in Science or Engineering and 8 years of operational validation experience in pharmaceutical, or biotechnology industry or  Bachelor’s degree in Science or Engineering and 10 years of operational validation experience in pharmaceutical, or biotechnology industry.
  • Experience in facilities, equipment and utilities commissioning &qualification and cleaning validation is required.
  • Experience in supervision of full time direct reports and contractors are required.
  • Experience in multiproduct pharmaceutical/ biotechnology manufacturing facility is a plus.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Analytical Associate Scientist

0
0

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Analytical Associate Scientist

Position Summary

We are seeking an experienced and motivated Analytical Associate Scientist to join our fast-growing company. The successful candidate will perform development and qualification of analytical methodologies for characterization of protein vaccine candidates. S/he will be responsible for formulation development, support stability programs for various vaccine candidates and provide technical support to process-development-related activities. Applicants should have a M.S. with 7 years or Bachelor with 10 years of industry experience in biochemistry, chemistry, pharmaceutics, or related field.

Primary Responsibilities

  • Perform lab-based activities related to the development and implementation of analytical methods as well as formulation development and vaccine stability programs
  • Participate in critical interpretation of experimental data
  • Participate in practical problem solving activities in relation to ongoing and new projects
  • Support process development group
  • Write technical reports
  • Use of problem solving and technical discretion in the design, execution and interpretation of projects.
  • Prepare slide decks independently and present them for internal company meetings.
  • Work cross- functionally within organization to achieve common goals.
  • Recognize anomalous and inconsistent results and interpret experimental outcomes.

Required Skills

  • A solid theoretical understanding of and experience with HPLC, ELISA, Octet, DLS and gel electrophoresis techniques.
  • Method development, assay qualification and validation experience is a big plus.
  • Ability to analyze data, draw conclusions, communicate results and compile technical reports
  • Excellent record keeping abilities to adequately record and document analytical data.
  • Displays solid technical knowledge and hands-on experience
  • Ability to work effectively in a cross -functional setting.
  • Good communication skills and the ability to multitask.
  • Hands-on experience with various analytical techniques including HPLC/UPLC, UV-vis and fluorescence spectroscopy, ELISA, Octet, DLS and electrophoresis.
  • An understanding of the fundamentals of formulation sciences is preferred.
  • Excellent communication, problem solving and analytical skills.
  • Strong organization and ability to manage multiple projects simultaneously.
  • Strong work ethic and ability to work well both individually and in a team environment.

Education & Experience

  • MS in biochemistry, chemistry, pharmaceutics, or related field with significant focus on protein-related studies with more than 7 years of industry experience or Bachelor’s with more than 10 years of industrial experience in protein-based biologics product development, formulation development or pharmaceuticals.

Please reference that you are applying for the requisition numbers MSB139

Sr. Scientist / Group Leader, EBV

0
0

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Sr. Scientist/Group Leader, EBV

Position Summary

Seeking a top notch contributor to join our dynamic and dedicated team. Reporting directly to the Director of Vaccines in the Vaccine Development group, the Sr. Scientist/Group Leader will be expected to apply an understanding of Epstein-Barr virus (EBV) virology and immunology towards the development of new vaccines candidates against EBV. The candidate will contribute with both technical and intellectual expertise to many levels of a program, including antigen screening and prioritization, adjuvant testing, immunization strategies, animal modeling, and external collaborations. The successful candidate will supervise of a team that supports the evaluation of immunogenicity and efficacy of candidate vaccine formulations in animal models and clinical trials. He/she will develop collaborations to advance Genocea’s EBV strategy through strong alliance management, driving publications, and representing the company at key scientific meetings.

Competencies

  •  Excellent communication, problem solving and analytical skills
  • Deep knowledge of EBV virology and immunology
  • Understanding of EBV-associated diseases
  • Solid technical knowledge and hands-on experience with immunological and virological techniques
  • Experience in vaccine development

Required Skills

  • Plan, implement and directly supervise complex projects
  • Assist in developing budgets
  • Familiarity with current scientific literature and ability to select methods and techniques for obtaining solutions within accepted practices and procedures
  • Provide guidance and supervision to multiple direct and indirect reports, demonstrate leadership skills, successfully develop and manage timelines
  • Assume lead role in providing solutions to difficult problems associated with specific projects
  • Ensure technical quality and compliance
  • Participate in development of patentable technology
  • Maintain broad knowledge of state-of-the-art principles and theory
  • Make important contributions to scientific projects, draft manuscripts for publication, present technical data at scientific conferences
  • Exhibit an exceptional degree of sustained ingenuity, creativity and resourcefulness
  • Application and/or development highly advanced technologies, scientific principles, theories and concepts that may be new to the industry
  • High-level creative problem solving and analytical skills, using technical discretion in the design, execution and interpretation of experiments that contribute to project goals

Education & Experience

MD or PhD with 7-10 years of relevant experience in infectious diseases, immunology, oncology, virology or related field. Relevant experience in industry is a plus.

 

Please reference that you are applying for the requisition number MSB140

Scientist / Sr. Scientist, Immuno-Oncology

0
0

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Scientist / Sr. Scientist, Immuno-Oncology

Position Summary

The Scientist/Senior Scientist Immuno-Oncology reports to the Head of Immuno-Oncology. He/she is responsible for the discovery and development of T cell antigens for cancer immunotherapy. In addition, the candidate will identify and develop Immuno-Oncology biomarkers.  S/he will design and perform experiments for internally- and externally-focused research programs. The candidate will effectively and routinely collaborate with colleagues in Discovery and Vaccine Development, as well as present scientific results to multidisciplinary teams and the leadership team at Genocea Biosciences.

The Scientist/Senior Scientist will contribute to the external scientific visibility of Genocea through publications and presentations at key scientific meetings and serve as a subject matter expert in immunology and oncology.

Primary responsibilities

  • Work collaboratively with other departments to characterize and identify the specificity of T cell responses to tumors and design and evaluate novel immunotherapies
  • Support R&D collaborations as a technical expert and scientific liaison
  • Critical interpretation of data, including formulation of suggestions for alternate approaches for data generation and evaluation
  • Integration with existing project teams
  • Drafting of manuscripts for publication in peer-reviewed journals

Required Skills

  • Experience in the development of cancer vaccines, including the evaluation of novel adjuvants and delivery systems is critical
  • Expertise in T cell culture, flow cytometric methods, and cell cloning is required
  • Experience with molecular biology including RNA, DNA and protein analysis is preferred
  • Experience with culture of tumor-infiltrating lymphocytes, in silico epitope predictions, TCR sequencing, and processing of human tumors for next generation sequencing is a plus

Candidate must:

  • work independently and manage multiple projects simultaneously
  • demonstrate the ability to analyze and present data in professional format
  • keep up-to-date with the literature related to his/her field
  • demonstrate clear and professional verbal and written communication
  • work and communicate effectively in a matrix environment

Education and Experience

A PhD or MD/PhD degree in oncology, immunology or tumor immunology related field, with at least 4 years of post-doctoral or industry experience working in tumor immunology or related field with a demonstrable record of scientific achievement is required

Please reference that you are applying for the requisition number MSB141

 

Image Analysis Developer, Nuclear Medicine

0
0

Make an impact at a dynamic and growing life sciences company. inviCRO seeks an accomplished scientist with experience in nuclear medicine physics and/or applications. The ideal candidate possesses graduate-level research experience as well as strong programming, image processing, and signal processing skills.

Overview:

This position is responsible for the development of analysis methodology, software tools, and algorithms for molecular imaging applications with a focus in nuclear medicine which may include, but is not limited to image registration, image segmentation, considerations in image reconstruction, technical support for DICOM and preclinical image formats, partial volume correction methods, tracer kinetic modeling, mechanistic modeling, general optimization techniques, and analyses of PET, SPECT, autoradiography, and gamma counter data. 

Responsibilities:

  • Develop image analysis methodology from concept through to validation, documentation, appropriate SOPs, and application in close cooperation with our research-driven customers
  • Translate image analysis tools and methods from prototype to deployment, including integration into established software platforms and dissemination to colleagues and customers successfully
  • Manage customer-specific analysis projects, including generation of appropriate inviCRO-standard supplemental materials (QC, plots, reports, spreadsheets) in parallel with project-specific analysis output
  • Oversee an image analysis team to achieve short-term and long-term image analysis goals 

Qualifications and Skills:

  • PhD or Masters with 2 or more years of relevant experience in image science,      computer science, or electrical engineering with a nuclear medicine focus
  • Knowledge of imaging modalities, primarily SPECT and PET with some experience with CT, and/or MRI and data formats, particularly DICOM
  • C++, including ITK & VTK, Matlab, and JavaScript expertise required, Perl      preferred
  • Strong analytical skills and ability to balance attention to detail while working to deadlines           
  • Ability to multitask and work to deadlines in an environment of change
  • Ability to learn quickly on the job through mentoring and action
  • Self-motivated and resourceful with good interpersonal skills
  • Ability to independently manage workflow to see projects through from start to completion
  • Strong programming, image processing, and signal processing skills are critical requirements

To apply: Send cover letter and resume indicating your authorization status to work in the United States to jobs@invicro.com. Please note job title in the subject line of the email.

Additional information about inviCRO

inviCRO, LLC, was founded in 2008 with a mission to apply imaging technology and tools to address biological questions in drug discovery and development.  inviCRO provides state of the art contract research, advanced data analysis services and software for utilization in drug research. In collaboration with partner imaging centers, inviCRO offers full-service contract research in vivo imaging services utilizing SPECT, PET, MR, CT and optical imaging technologies, as well as ex vivo 2D and 3D autoradiography, fluorescence, and histology. Our multidisciplinary team of scientists develop unique imaging and bioinformatics tools that inform the design and analysis of imaging trials across many species and therapeutic areas. Our team brings together specialized knowledge in a broad range of disciplines, including advanced degrees in physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics.

We currently manage or support more than 250 pre-clinical and clinical imaging studies per year, processing more than 30,000 medical images per quarter. Our software products are helping scientists at more than half of the top 25 pharmaceutical companies. Visit www.invicro.com for more information.

 

Viewing all 17099 articles
Browse latest View live




Latest Images