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Career postings for the Massachusetts Biotechnology Council

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    Senior/Staff Scientist: Molecular and Cell Biology/Antibody 

    About Acceleron: 

    Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. 

    Position overview: 

    We are seeking an experienced and highly motivated Scientist with expertise in molecular and cellular biology with focus on biologics discovery and development to join our R&D team. This hire will play a key role in the development of unique new products and will be required to interact across teams internally as well as with external parties. This person will be responsible for management of antibody projects, including vector construction, antibody production in mammalian cells and antibody characterization. In addition the candidate will be involved in the construction and in vitro evaluation of various discovery molecules using different cellular assay formats such as reporter gene assays, flow cytometry, ELISA, etc. We are looking for a candidate who has demonstrated a natural flair for innovation, outstanding analytical skills, and the ability to manage complex projects from conception to completion. Experience in supervising the work of others and managing key collaborator relationships would be a great advantage. You will have a self-starting attitude, willing to go to lab to get the project started, leadership qualities, excellent interpersonal and organizational skills, and the ability to work under tight deadlines. The title will be determined based on the experience.

    Basic Qualifications: 

    • PhD in molecular biology, cell biology,  biochemistry or related field
    • 5-10 years of recent hands-on experience in development of protein therapeutics
    • Ability to manage all aspects of the design, engineering, and generation of protein therapeutics (especially monoclonal antibodies)
    • Technical expertise in molecular and cellular biology, cloning, vector construction, mammalian cell culture and cell line development is essential.
    • Detailed understanding of biologics production and process optimization including antibodies is required
    • Previous experience working with bispecific antibodies is a plus.
    • Hands-on experience in design, implementation and troubleshooting of cell based assays including reporter gene assay development, FACS, MSD, ELISA, etc along with data interpretation is required
    • Ability to distill complex issues and clearly articulate innovative solutions
    • Ability to communicate effectively by oral presentation, written technical reports, and scientific publications
    • Ability to lead, influence and motivate others
    • Highly analytical mind, attention to details, and organizational skills are critical
    • Highly self-motivated with a strong sense of responsibility and a collaborative spirit.
    • Strong communication, interpersonal and teamwork skills are essential 

    *Recruiters - please do not send unsolicited resumes to this posting.

    FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

    www.acceleronpharma.com

     

     

     


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  • 01/25/16--09:00: Program Manager
  • General Scope and Summary

    This is an exciting opportunity to work in a multi-faceted program management role.  Key aspect of the role is to support Discovery and Development Project Leaders with overall program coordination including developing and tracking program timelines and plans and being a focal point of team communications including meeting organization and follow-up.  Interact collaboratively with team members at Sage to ensure alignment on project action items and deliverables.  Facilitate the use of program management tools throughout company.

    Roles and Responsibilities

    • Assist Program/Product Team Leaders to integrate, document and communicate program plans, track progress and re-forecast as necessary in conjunction with team 
    • Manage program timelines, deliverables, metrics and budget
    • Organize team meetings including agendas, pre-work, minutes, action items and overall program correspondence
    • Assist with execution of project plans within a team environment.  Institute a development pathway with decision stage gates
    • Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities.  Ensure detail on investments to be made across the portfolio and $ to complete are well understood and coordinated
    • Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies
    • Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project
    • Develop and implement communication tools that enhance information exchange and stimulate creative project interactions
    • Assist Project Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations and other appropriate meetings involving moving through the key decision points of a program

    Experience, Education and Specialized Knowledge and Skills

    • Bachelor’s degree in science, business or equivalent - advanced degree preferred
    • 3+ years experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry
    • Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
    • Strong knowledge of MS Office
    • Demonstrated ability to work successfully in a matrix environment
    • Excellent verbal and written communication, negotiation, team building, presentation, and interpersonal skills
    • Established ability to work independently, prioritize and manage multiple tasks simultaneously, and demonstrated ability to identify and resolve issues
    • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player

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    General Scope and Summary

    This is an exciting opportunity to work in a multi-faceted program management role.  Key aspect of the role is to support Discovery and Development Project Leaders with overall program coordination including developing and tracking program timelines and plans and being a focal point of team communications including meeting organization and follow-up.  Interact collaboratively with team members at Sage to ensure alignment on project action items and deliverables.  Facilitate the use of program management tools throughout company.

    Roles and Responsibilities

    • Assist Program/Product Team Leaders to integrate, document and communicate program plans, track progress and re-forecast as necessary in conjunction with team 
    • Manage program timelines, deliverables, metrics and budget
    • Organize team meetings including agendas, pre-work, minutes, action items and overall program correspondence
    • Assist with execution of project plans within a team environment.  Institute a development pathway with decision stage gates
    • Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities.  Ensure detail on investments to be made across the portfolio and $ to complete are well understood and coordinated
    • Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies
    • Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project
    • Develop and implement communication tools that enhance information exchange and stimulate creative project interactions
    • Assist Project Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations and other appropriate meetings involving moving through the key decision points of a program

    Experience, Education and Specialized Knowledge and Skills

    • Bachelor’s degree in science, business or equivalent - advanced degree preferred
    • 3+ years experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry
    • Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
    • Strong knowledge of MS Office
    • Demonstrated ability to work successfully in a matrix environment
    • Excellent verbal and written communication, negotiation, team building, presentation, and interpersonal skills
    • Established ability to work independently, prioritize and manage multiple tasks simultaneously, and demonstrated ability to identify and resolve issues
    • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player

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    Title: Senior Director/Director, Development Team Lead, SAGE-689/217                       

    Reports to: VP, Portfolio & Program Management

    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program executive experience leading early to late stage drug development programs.

    Roles and Responsibilities

    • Define and articulate clear strategic vision within program teams
    • Operational leader for the product development/early development projects and serve as visible program champion and focal point for critical program information
    • Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
    • Set and maintain focus on overall program objectives and milestones but knowledgeable of supporting detail (tasks, associated expert resources and expense)
    • Drive decision point planning and associated deliverables across all functions of the team and contributes to the Sage portfolio planning process on behalf of the program(s)
    • Ensure the input from sub-teams to support the advancement of the program’s objectives and deliverables
    • Perform full program planning and execution within team environment
    • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
    • Propose resource needs for Program
    • Develop and own budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.
    • Program Status Reporting - ensure program is viable and aligned with corporate strategy
    • Accountable for meeting targets and managing deliverables
    • Issue Identification and Resolution
    • Cross-Functional Coordination and Communication including senior management
    • Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • Advanced degree and 15+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct project/program management experience in preclinical and clinical development, ideally honed through a combination of portfolio prioritization, working within a medical affairs organization (or similar) with emphasis on discovery to early development transition
    • Demonstrated knowledge of overall drug discovery and drug development processes relevant to pharmaceutical/biotech organizations as evidenced by multiple successful drug discovery program leadership experience
    • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
    • Capable of managing multiple programs/brands simultaneously
    • Previous experience with portfolio management concepts preferred; must have advanced planning and tracking skills with attention to detail including experience with project management and tools (i.e., MS Project)
    • Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
    • Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors
    • Possesses strong written and verbal communication skills
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Excitement about the vision and mission of SAGE

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    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for strategic regulatory activities related to SAGE’s clinical development programs.

    Roles and Responsibilities

    • As a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
    • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
    • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
    • Organize and manage regulatory meetings with health authorities.
    • Review materials for compliance with advertising and promotion regulations.
    • Perform regulatory strategic assessments for new product candidates and new indications.
    • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
    • Manage contract staff and vendors as needed to support regulatory activities.
    • Provide create and innovative solutions while being an advocate for compliance.

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • 7-10 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
    • Bachelor of Science in a scientific discipline, MS or PhD preferred
    • Strong knowledge of eCTD elements and structure
    • Strong regulatory writing skills and use of Microsoft WORD
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Strong team player that has a customer service approach and is solution oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication and presentation skills.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of Sage

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    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for quality document management and training.

    Roles and Responsibilities

    Documentation Management           

    • Participate with Quality/Regulatory leadership in the development of the Quality Manual, process mapping and Quality Documentation infrastructure for a growing and multi-product business.
    • Develop and implement process maps/workstreams for efficient documentation workflows.
    • Actively promote the requirements and capabilities of the Quality Documentation System throughout the organization with current and future strategies for the Quality Documentation System (EDMS, cloud-based computerized systems).
    • Author, review and approve controlled written standards, including Master Production Records, Standard Operating Procedures, Specifications, Qualification/Validation Protocols, Test Methods, and Deviations and Change Control Documentation related to the Quality Management System.
    • Provide oversight and linkage to Training curricula for on-time operations in compliance with GxP, regulatory requirements and Quality Manual/procedures.
    • Participate and contribute to Quality/Regulatory budget for Documentation and Training.
    • Provide support during internal and external audits related to Regulatory and internal audits for Documentation/Training.

    Training Management

    • Lead, manage and execute an Annual Training Plan for all GxP employees in line with current and future Quality/Regulatory strategies.
    • Identify associate capability &/or training needs by consulting with business managers, human resources and conducted needs analysis.
    • Develop training curricula for employee functions for GCP/GLP/GMP processes
    • Conduct instructor led training programs including the “why” for presenting complex issues to a diverse audience. Assess training effectiveness to ensure transfer of skills and knowledge into associate work behavior
    • Lead the creation, review and update of a Learning Management systems: for programs, content, while working with internal stakeholders and systems experts to track and deploy eLearning as appropriate.
    • Develop and present formal recommendations for enhancements, upgrades and business process changes related to Documentation and Learning Management Systems.
    • Establish and deploy timely metrics for Documentation and Training Management leading to action plans for Quality Council/meetings for continuous improvement.
    • Use expertise in the latest learning and development methods and adult learning theory to shape and design learning programs through networking and benchmark, identify best industry practices

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills and ability to develop relationships with key stakeholders.  Ability to communicate issues in a simple way and to orchestrate plans to resolve issues and risks.

    • B.S/B.A. in an engineering, operations or science degree
    • 10+ Quality Assurance experience including 5 years experience in Documentation/Training eLMS systems
    • Possess in-depth knowledge of GCP/GLP/GMP regulations, principles, concepts, industry practices and standards
    • Strong knowledge of quality assurance processes and procedures including sterile/solid dosage manufacturing
    • Extensive knowledge of instructional design theory, adult learning principles and methods for curriculum design
    • Proficient in validation / computerized system validation / Part 11 requirements with demonstrated experience in implementation of a Document Management System (User Requirements, beta-testing, writing/executing protocols) while building internal and external relationships with vendors, consultants and key stakeholders 
    • Excellent knowledge in MS Office, Visio, MS Project, eLMS, EDMS systems and database software
    • Excellent interpersonal, problem solving, risk analysis and negotiation skills
    • Effective organization, communication, and team orientation skills
    • Ability to coordinate timelines with internal customers and external clients and vendors
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication skills
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of SAGE

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    Seeking a Contract Medical Writer for one of Aerotek's best clients!

    This is a 12 mo renewable contract.

    Partial remote opportunity. Will be asked to go into the office in Cambridge 1-2 times per month (on average) for office/group meetings.

    Looking for a Medical Writer who is able to committ 40 hours per week

    Seeking a Contract Medical Writer for one of Aerotek's best clients!

    This is a 12 month renewable contract. Candidates must be able to work 40 hours per week.

    ** Please note: This is a partial remote opportunity. Will be asked to go into the office in Cambridge 1-2 times per month (on average) for office/group meetings.

    Job Description and Qualifications:

    • Specialty: Oncology

    • Ideally looking for a candidate who has biomarker analysis experience

    • Must have experience working across multi-disciplinary teams

     


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    Requsition Number: 169706BR

    Job Purpose Accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM). Senior Clinical Trial Leader (CTL) on the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). Responsible for program level activities; may also function as a Lead CTL.
    Major Accountabilities 1.Clinical Trial Leader for Phase I/II including multi-country / multi-center trials. The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration. 2.Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members. 3.Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings. 4.Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised. 5.Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility. 6.May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc. 7.Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner. 8.Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements. 9.Accountable for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines. 10.Contribute to the evaluation of clinical sites and external service providers for performing TM studies in healthy volunteers and patients. 11.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions. 12.Oversee and coordinate the work of assigned support Clinical Trial Associate(s) and Clinical Scientist(s) at the study/project level ensuring clear delegation /assignment of duties are documented. 13.May function as a Lead CTL on one or more projects. Additional responsibilities of a Lead CTL may include: contributing to project level documentation, coordination and consistency of activities across TM studies within a project, development of program specific standards, assisting in the coordination of TM related submission documents, and attending and participating in project team meetings, as required. 14.Provide expert advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned. 15.Identify and help implement areas for process improvements. 16.Contribute to talent and career development of CS&I and TM staff through active participation in on-boarding, training and mentoring activities of new CS&I or TM hires. In collaboration with CS&I management, contribute to the hiring/interview process for new CS&I or TM hires. 17.Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned. 18.Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTAs and Clinical Scientists.

    Education (minimum/desirable): PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
    Languages: Business-level written and oral English
    Experience/Professional Requirement: 1.At least 6+ years experience in clinical trials / drug development. 2.Extensive knowledge of Good Clinical Practice. 3.Track record of successfully managing multiple concurrent phase I and IIa, complex clinical trials. 4.Office and clinical trial software IT computer literacy. 5.Demonstrated leadership and problem-solving skills. 6.Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. 7.Clear written and verbal expression of ideas, an active/proactive communicator. 8.Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships. 9.High level of customer orientation awareness and focus. 10.Used to working independently and in a team environment, being flexible and adapting in a changing environment.


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    COMPANY:

    The development of CRISPR/Cas9 gene editing technology opens a new frontier in biomedical research and clinical intervention. Adapted from a natural cellular process, CRISPR/Cas9 permits the editing of any gene in any organism with unprecedented simplicity and flexibility. Intellia Therapeutics was founded in 2014 by Caribou Biosciences and Atlas Venture, along with a consortium of leading scientists who have helped define the space. Intellia Therapeutics holds exclusive access to a broad intellectual property portfolio covering the application of CRISPR/Cas9 technology for human therapeutic use. As we build our team, we’re looking for people who share our commitment and energy to make a difference.

    SUMMARY:

    Intellia is seeking highly skilled and motivated cell biologists to join our growing team. The primary responsibilities for this position will be to support the identification and prioritization of lead candidates through functional cell-based assays following next-generation sequencing (NGS) screening.

    APPLY HERE

    GENERAL RESPONSIBILITIES:

    • Maintain and generate mammalian cell lines and primary cells
    • Purify genomic DNA and perform NGS library preparation
    • Perform established functional cell-based assays
    • Execute experiments to troubleshoot and optimize protocols
    • Develop appropriate functional assays to support specific programs
    • Communicate research and development findings with internal teams

    REQUIRED SKILLS:

    • Extensive experience with cell culture and transfection techniques
    • Experience and understanding of standard molecular biology techniques
    • Competence with cell-based assays, Western blotting, immunoprecipitation, and ELISA

     PREFERRED SKILLS:

    • Experience with primary mammalian cells is a plus
    • Ability to perform cell-based assays in high-throughput formats

    QUALIFICATIONS:

    • B.S. in biology, molecular biology, or related field with at least 3 years of industry experience, or M.S. in biology, molecular biology, or related field with at least 1 year of industry experience.
    • Local applicants preferred

     

     COMPETENCIES:

    Attention to detail

    Ability to follow Standard Operating Procedures (SOPs)

    Exceptional time management

    Effective communication skills (both written and verbal)

    Ability to work independently and collaboratively

    Ability to thrive in a team

     

    POSITION: Full-Time, Exempt

     

    APPLY HERE 

     


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    Requsition Number: 169705BR

    Job Purpose Accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM). Clinical Trial Leader (CTL) on the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).
    Major Accountabilities 1.Clinical Trial Leader for Phase I/II studies including multi-country / multi-center trials. 2.Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members. 3.Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings. 4.Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised. 5.Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility. 6.In collaboration with the Medical Expert and CTT, manage the ongoing medical/ sci-entific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are trans-ferred/available in a timely manner. 7.Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements. 8.Responsible for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines. 9.Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers. 10.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions. 11.Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear del-egation /assignment of duties are documented. 12.Act as a mentor to support the training and on-boarding of new CS&I associates. 13.Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned. 14.Identify areas for process or technology improvements. 15.Responsible for following best practices and standards for trial management within TM; expected to share lessons learned. 16.Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists.

    Education (minimum/desirable): PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
    Languages: Business-level oral and written English
    Experience/Professional Requirement: 1.Approximately 3-6 years experience in clinical trials / drug development. 2.Good knowledge of Good Clinical Practice. 3.Track record of successfully managing multiple Phase I and IIa clinical trials concurrently. 4.Office and clinical trial software IT computer literacy. 5.Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. 6.Clear written and verbal expression of ideas, an active/proactive communicator. 7.Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships. 8.Customer orientation awareness and focus. 9.Used to working independently and in a team environment, being flexible and adapting in a changing environment.

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    GENERAL SUMMARY OF POSITION:

    A research position is available in the Benanti laboratory to study the molecular mechanisms that control cell growth and division. This individual will work closely with the principle investigator to carry out an independent research project and also have lab organization responsibilities. A degree in cell biology, molecular biology, genetics or related area and some lab experience is required. Applicants must be highly organized and independent. Recent graduates are encouraged to apply. This is an ideal position for someone interested in going to graduate school in 2-3 years.

     

    Under the supervision of the Principal Investigator or designee, the Research Laboratory Technician I, performs a variety of specimen preparatory techniques, dry lab data collection, and routine laboratory maintenance.

     

    Please include names and contact information for three references. Recent graduates should also include degree date, GPA, and list of relevant coursework.

     

     

    MAJOR RESPONSIBILITIES:

    • Perform a variety of laboratory experiments using both routine and special techniques and methods
    • Assist in more complex laboratory tasks
    • Collect, analyze, and process laboratory samples
    • Record results, organize data, and perform basic computations
    • Maintain laboratory supplies and equipment
    • Comply with all safety and infection control standards
    • Perform other duties as required.

    REQUIRED QUALIFICATIONS:

    • Bachelor's degree in Biological Science or equivalent experience
    • Knowledge of Microsoft Office products
    • Ability to perform duties independently
    • Judgment and action skills required to solve commonly encountered problems

    SUPERVISION RECEIVED:

    Under the supervision of the Principal Investigator or designee

     

    SUPERVISION EXERCISED:

    None

     

    ENVIRONMENTAL WORKING CONDITIONS:

    Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.



    Apply Here

    PI92762859


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    GENERAL SUMMARY OF POSITION:

    A research position is available in the Benanti laboratory to study the molecular mechanisms that control cell growth and division. This individual will work closely with the principle investigator to carry out an independent research project and also have lab organization responsibilities. A degree in cell biology, molecular biology, genetics or related area and some lab experience is required. Applicants must be highly organized and independent. Recent graduates are encouraged to apply. This is an ideal position for someone interested in going to graduate school in 2-3 years.

     

    Under the direction of the Principal Investigator or Designee, the Research Associate performs a variety of complex research experiments.

     

    Please include names and contact information for three references. Recent graduates should also include degree date, GPA, and list of relevant coursework.

     

     

     

    MAJOR RESPONSIBILITIES:

    • Conducts in-depth analysis of research experiments
    • Performs complex laboratory experiments
    • Interprets data, forms conclusion, and decides on and plans next experiments to be done with a high degree of independence
    • Compiles and analyzes data and performs computations using image analysis software, spreadsheets, graphing, and curve fitting software
    • May modify protocols and be responsible for a single, independent research project
    • Assists in writing the text of scientific publications and grants. Reviews literature
    • Trains new laboratory personnel, students, and collaborators
    • Maintains laboratory supplies and equipment
    • Complies with all safety and infection control standards
    • Perform other duties as required

    REQUIRED QUALIFICATIONS:

    • Bachelor's degree in Biological Sciences, or equivalent experience
    • 1 year relevant research experience
    • Knowledge of Microsoft Office products
    • Strong ability to analyze complex visual data in a quantitative and objective manner
    • Judgment and action skills required to solve commonly encountered problems
     

    SUPERVISION RECEIVED:

    Under the direction of the Principal Investigator, or designee

     

    SUPERVISION EXERCISED:

    May functionally supervise Lab Technicians and Aides

     

    ENVIRONMENTAL WORKING CONDITIONS:

    Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.



    Apply Here

    PI92762882


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    Company Overview:

    Berg is a Greater Boston based company that employs a novel approach to systems biology and utilizes systems engineering and bioinformatics modules to cross-validate biological output. The Berg Interrogative Biology™ Drug Discovery Platform allows for rapid and precise identification of therapeutic and biomarker candidates for drug discovery and development. The company uses network biology to mine disease pathophysiology. 

    Job Description:

    Reporting to the Director of Network Systems Administration, the Network Systems Administrator is responsible for managing, supporting, and implementing information technology projects to augment, enhance, and/or replace business systems and network infrastructure throughout Berg’s Framingham, Massachusetts office.  This position will also serve as an escalation point for challenging IT Help Desk issues.

    Responsibilities:

    • Participate in ensuring the stability of all of Berg’s information technology systems with teamwork and professionalism, including, but not limited to, carrying and responding to a mobile phone and being available when needed for critical system support
    • Develop technical specifications and timelines for various information technology projects for the purpose of prioritization and work flow management
    • Analyze and resolve complex technical compatibility issues amongst multiple systems and recommend solutions that are consistent with Berg technology & security standards
    • Maintain network security and access to resources by creating, editing, or deleting user accounts, network shares, e-mail lists, and access control lists with attention to appropriate security procedures
    • Maintain the security of servers and data by ensuring operating system updates and virus protection are installed as well as finding and eliminating malicious applications
    • Manage project implementation to on-time, on-budget completion, which may include coordinating the work of contracted resources and internal staff
    • Create and/or implement technical solutions for individual project components as needed to make the technology fit the business need
    • Facilitate planning and efficiency by communicating project specifics and status appropriately and effectively to internal Berg audiences and IT leadership
    • Provide well-written, concise documentation and appropriate training for technical solutions to support on-going operational support by junior-level support staff and Berg-wide technological literacy
    • Provide the highest level of technical support for information technology systems and infrastructure to ensure system reliability and act as the highest technical point of escalation for team members
    • Provide outstanding customer service to Berg staff and serve as a role model to junior team members
    • Perform other work-related duties as required by the Director of Network Systems Administration

    Qualifications:

    • Requires a B.A. or B.S. in Information Technology, Business, or equivalent with a minimum of 3-5 years’ experience in a fast-paced, IT support environment. Alternatively, 5-7 years’ experience in all aspects of the information technology field
    • Ability to be a team player and the ability to multi-task in a fast-paced, pharmaceutical environment; experience in a biotechnology lab-oriented environment a plus
    • Ability to work flexible schedules as needed
    • Significant customer service/support experience a plus
    • Demonstrated project management and exemplary customer service skills to facilitate the planning and implementation of information technology projects
    • Ability to meet deadlines and manage time to meet the needs of a variety of situations
    • Demonstrated ability to mentor junior staff in customer service skills, technical skills, and familiarity with both industry and organizational IT and project management best practices
    • Understanding of information systems privacy and security issues including common practices for protecting systems
    • Strong listening and problem-solving ability
    • Ability to explain and document computer systems in terms equivalent to user’s experience level
    • Comprehensive knowledge of and extensive hands-on experience with network administration including the following:
      • TCP/IP networking and related protocols
      • Cisco Catalyst & Nexus switches and routers (CCNA highly desired)
      • CheckPoint security gateways & endpoint protection
      • Converged communications administration (VOIP & videoconferencing)
      • Enterprise class storage solutions (on premises & cloud-based, EMC VNX, Dell EqualLogic)
      • Enterprise class wireless networks (Aruba Networks experience highly desired)
      • VMware vCenter & vSphere hypervisors
      • Windows Active Directory (Server 2008 R2 / 2012 R2; LDAP & RADIUS)
      • Ubuntu Server Linux
      • Enterprise systems backup & recovery methodologies
      • Network cabling design & implementation (Cat 5E/6 & fiber optic)
      • Demonstrated ability with Internet/Intranet coding tools and scripting (e.g. PowerShell, Bash, PHP, ASP, etc.)
      • General knowledge of and some experience with the following:
        • Apple Mac operating systems and networking
        • FDA 21 CFR Part 11 requirements
        • Good Laboratory Practice (GLP) & Good Manufacturing Practice (GMP) principles

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  • 01/25/16--09:12: Sr. Principal R.A./Scientist
  • Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics.  We are looking for a creative, talented and highly motivated scientist to join our interdisciplinary team to help advance novel RNAi therapeutic programs from discovery through clinical development, with a particular focus on orphan genetic, as well as metabolic diseases.  This position will be a laboratory based, and requires strong background in drug metabolism and pharmacokinetics. Technical skills include conducting in vitro ADME assays, experience with cell culture (including primary hepatocytes). Pharmacokinetic/Pharmacology background is preferred. Knowledge in biochemistry and molecular biology is a plus. The successful candidate must be highly flexible and collaborative, efficient at multi-tasking, well-organized, detail and results oriented, team-player, fast learner, citical thinker and have analytical approach to problem solving. 

     

    Summary of Key Responsibilities:

    • Design and execute studies to understand distributional properties of new molecular entities (NME).
    • Develop and conduct assays (e.g. in vitro cell based assays, qPCR, LC-MS, HPLC, Western blot) involving quantitative analysis of test compound
    • Perform PK analysis using PK data analysis software, like Phoenix WinNonlin.
    • Prepare high quality experimental reports and data presentations
    • Maintain accurate and timely records of experimental designs, assay development, experimental results, data analysis, and interpretation within laboratory notebooks.
    • Excellent oral and written communication skills.
    • The ability to work well in a collaborative fast-paced, matrix team environment.

     

     

    Qualifications:

     

    • Requirements include a Masters (with 8-10 years) or Ph.D. (with 0-2 years’ experience) in a relevant scientific field.
    • Previous pharmaceutical industry experience within relevant scientific discipline is desirable.
    • The ideal candidate should have skills to develop assays and troubleshoot in new areas of development. In case there is no prior experience with certain skills, desire to learn quickly is strongly encouraged.
    • Desire to drive innovation and contribute intellectually in a highly matrix collaborative team environment.
    • Title and compensation will depend on years of previous relevant experience and scope of responsibilities.

     


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  • 01/25/16--09:53: Manager, Market Research
  • Overview:

    Alnylam is committed to a vision of harnessing RNA interference for human health with the goal of developing and commercializing RNAi therapeutics for patients in need of new treatments. For our company to be successful, we must deeply understand the unmet needs of the stakeholders we serve and align our products to meet those needs. Alnylam is seeking to build its market research capabilities to ensure we engage these stakeholders and develop clear insights into how our products can meet their needs. The Manager, Market research will work in close alignment with Alnylam program teams across multiple therapeutic areas to develop impactful and innovative market research programs and will work with our commercial and business planning teams to develop an appropriate suite of market research tools and capabilities. The position will report to the Senior Manager, Market Insights.

    Summary of Key Responsibilities:

    Responsibilities

    • Manage the conduct of primary and secondary market research to support the development of product opportunity assessments for multiple products across the Alnylam pipeline
    • Employ tools, modeling techniques, and analytical methods to highlight key features of Alnylam markets and products and inform the design of strategy, positioning, and initiatives
    • Synthesize market insights by accessing and integrating multiple sources of market and competitive data
    • Implement processes, tools, and technology required to support market research projects for commercial-stage biotechnology company
    • Present findings from market research in front of mixed audiences of commercial, clinical, medical, operational, and executive audiences and build credibility for the market research function
    • Keep abreast of market & industry developments and incorporate applicable elements into market insights
    • Work collaboratively with internal customers in the clinical, medical, and commercial organizations ensure market research addresses key program uncertainties
    • Integrate market research into product opportunity working group to ensure that forecast assumptions are fact-based and reasonable
    • Create and maintain comprehensive and up-to-date assessments of relevant therapeutic markets, including epidemiology, treatment trends, unmet need, key market developments and competitive analysis
    • Evaluate and recommend new primary and secondary data sources and vendors
    • Develop suite of market research methodologies for use in insight development
    • Develop a robust system of communicating the output of market research and ensuring the data are available when needed for decision making

    Abilities and Attributes

    • Ability to manage multiple projects concurrently
    • Experience with market research best practices and ability to recommend and implement new processes, tools and technology within a growing organization
    • Initiative to advocate for and demonstrate value of the market research function and to access the resources needed to build market research capabilities
    • Strong technical/analytical skills to identify and solve problems
    • Strong understanding of statistics and research methodologies for market research projects to ensure quality and actionable output
    • Excellent oral and written communication skills
    • Ability to interface with all levels of management and multiple departments
    • Confidence for presentations to large, mixed audiences
    • Track record for completing assignments on-time and on-budget.
    • Willingness to work collaboratively and experience incorporating diverse perspectives into project decision-making.
    • Proven ability to work with a high level of integrity, accuracy, and attention to detail
    • Resourceful, tenacious, creative, enthusiastic, and results-oriented.
    • Self-motivated, assertive, and self-confident
    • Entrepreneurial, enjoys working in a fast-paced, small-company environment.
    • Bias for action and passion for excellence
    • Strong organizational skills
    • Strong interpersonal and teambuilding skills

    Qualifications:

    Job Requirements

    • Bachelor’s degree, preferably in a Business or Science field
    • A minimum of 3 years of experience conducting or managing market research for the pharmaceutical, biotech, or similarly regulated industry
    • Understanding of market research methods and data analysis
    • Ability to develop analysis and presentations with standard tools (i.e., Excel, Powerpoint)
    • Proven ability to manage time effectively and handle multiple conflicting priorities
    • Experience developing market/product forecasting based on market research output preferred
    • Experience working in rare diseases preferred
    • Strong working understanding of the drug development process preferred
    • Knowledge of pharmaceutical secondary data sources (e.g., IMS, patient/claims data, etc.) preferred
    • Experience with emerging market research methods (i.e., social media) preferred

    Expectations:

    Clear alignment with Alnylam Core Values:

    • Commitment to People
    • Innovation and Discovery
    • Sense of Urgency
    • Open Culture
    • Passion for Excellence

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


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  • 01/24/16--22:30: Medicinal Chemist
  • Medicinal Chemistry

    Positions Available

     

    Department of Microbiology and Immunobiology

    Harvard Medical School

     

    The Department of Microbiology and Immunobiology at Harvard Medical School seeks to fill two medicinal chemistry positions to support antiviral and antibacterial research programs.  Program goals are to identify novel antiviral and antibacterial targets as well as lead compounds that address those targets for pathogens that include dengue virus, Ebola virus, Staphylococcus aureus, Escherichia coli, Acinetobacter  baumannii, and Pseudomonas aeruginosa

     

    The individuals filling these positions will be key personnel on a multidisciplinary team supporting antiviral and antibacterial research and therapeutic development efforts funded by NIH grants led by Drs. Dennis Kasper and Sean Whelan.  Responsibilities will include analysis of hits from small molecule screening for drug-like properties, design and synthesis of analogs for structure-activity relationship studies and for use as biological probes, and enhancement of pharmaceutical properties of promising lead compounds that will enable in vivo efficacy studies. This work will be conducted in close collaboration with Harvard faculty and research staff.

     

    This is an exciting opportunity to join a program that has successfully developed technology licensed to biotechnology and pharmaceutical companies, published in leading scientific journals, filed patent applications, and competed for federal funding.

     

    Candidates should hold a Ph.D. in chemistry or a related discipline and have a minimum of 4 additional years of experience in organic synthesis of molecules to be used either as probes of biological systems or as candidate drug substances.  Experience in developing and executing structure/activity relationship studies to improve the specificity, potency, and drug-like properties of small molecules is essential.  Experience in antimicrobial drug discovery and development is highly desirable.

     

    Interested individuals should send a letter of introduction and CV to

     

    Gerald A. Beltz, Ph.D.

    Department of Microbiology and Immunobiology

    Harvard Medical School

    77 Avenue Louis Pasteur, Room 1032

    Boston, MA  02115

    P:  617-432-5520

    gerald_beltz@hms.harvard.edu


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    General Scope and Summary

    Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a highly-visible role that is responsible for key regulatory activities supporting the development and commercialization of Sage's products, with a focus on developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions.  Responsibilities will include: development and implementation of strategy for the earliest possible product approval, preparation and review of CTD Module 3, QOS, and other documents for FDA submission, assistance with preparation for FDA meetings, regulatory review and approval of cGMP documentation, and general regulatory compliance activities.


    Roles and Responsibilities

    • As a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
    • Compile, review, approve and submit CMC and marketing registration applications, amendments, and supplements.
    • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
    • Act as primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues;
    • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;
    • Manage contract staff and vendors as needed to support regulatory activities.
    • Provide create and innovative solutions while being an advocate for compliance.

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • 5-10 years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, CNS experience preferred.
    •  Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred
    • Established working knowledge of regulatory guidelines and regulations (US and international).
    • Regulatory experience supporting both development projects and marketed products.
    • Strong knowledge of eCTD elements and structure and regulatory writing skills.
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Strong team player that has a customer service approach and is solution oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication and presentation skills.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of SAGE.

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  • 01/24/16--23:07: Contracts Manager
  • The Contracts Manager will be part of a newly formed legal department. The individual will be responsible for assisting the Senior Corporate Counsel in the administration and coordination of contracts.  

    Responsibilities:  

    • Manage vendor, supplier and other contracts, including review, negotiation, renewal options, amendments and expirations
    • Manage a contracts database including new contracts and renewal of contracts including CAF (Contract Approval Forms)
    • Work with our clinical team on ensuring all vendors are in place with appropriate contracts for the start-up of our clinical study
    • Negotiate contract terms and conditions and interpreting existing contracts as needed
    • Issue and maintain database of contracts, non-disclosure and confidentiality agreements
    • Help drive departmental initiatives, including the redesign of legal support processes, contract programs and templates, and the use of technologies to increase efficiencies

    Qualifications:

    • Bachelor’s degree from an accredited institution preferred
    • 5+ experience working in contract management
    • Experience with preparing and reviewing non-disclosure and confidentiality agreements is required
    • Must be organized and have excellent oral and written communication skills
    • Strong interpersonal skills
    • Ability to operate independently and seek out guidance and expertise internally and externally as needed
    • Ability to identify and resolve problems in a timely manner and independently analyze information skillfully
    • Maintain confidentiality in all matters
    • Intermediate to advanced computer skills including Microsoft Office (i.e., Word, Excel, PowerPoint and Outlook) and online research
    • Team oriented, with a good sense of humor, sound judgment, self-motivation and willingness to take initiative

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    General Scope and Summary

    Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a highly-visible role that is responsible for leading the creation of a data science department and team for Sage.  This includes all Data Management, Biostatistics and programming activities that support development and future commercial programs worldwide. 

    Responsible for the creation and implementation of statistical and data handling strategies to support clinical development programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders. Participate as an active member of a multi-disciplinary team to plan and manage the Data Management tasks required for phase 1-4 studies.  Drive the delivery of end-to-end study data quality and integrity from source through publication/submission to archiving. 

    This key role will be responsible for leading the the development and implementation of innovative trial design, statistical model and analysis strategies that will optimize the drug development programs in terms of time, risk and cost as well as providing data analytical support to marketing-based activities.  As a member of the development team, provide statistical input for clinical development plans as well as for regulatory submissions and interactions with regulatory agencies.  The incumbent will also provide direct oversight of Contract Research Organizations (CROs) providing tactical support to development projects.  This position will report to the.

    Roles and Responsibilities

    • Biostatistics and Programming
    • Partner with senior company leadership on creation of corporate-wide strategies for success in documents such as Target Product Profiles, Clinical Development Plans, Risk Management Plans, Briefing Books, etc
    • Create and direct the development of statistical strategies for individual trial design as well as clinical development plans with emphasis on innovative strategies to optimize product development and regulatory approval
    • Provide statistical feedback to questions arising from regulatory agencies, non-clinical and marketing activities
    • Lead statistical discussions with external opinion leaders and counterparts at regulatory agencies
    • Collaborate closely medical and clinical operations groups to ensure efficient interactions across all clinical groups
    • Oversee data handling activities of CROs including data management, data standards, programming and statistics
    • Provide statistical review and approval of documents including protocols, SAPs, data management plans, table/listing/figure output programming,  statistical analyses, clinical study reports, briefing books, etc
    • Provide data analyses/summaries to support corporate needs as required
    • Direct activities of internal technical staff, as required

    Data Management

    • Lead Phase I – IV Data Management teams comprising internal and external data management resources.  Oversee the management of clinical trials data or data management projects under aggressive timelines in a high quality and professional manner.  Ensure requirements for capture and processing of clinical data are created to ensure accuracy, consistency and completeness of the data while adhering to SOPs and work guidelines as required. 
    • Direct the oversee Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
    • Direct the development of data management SOPs and processes.
    • Oversee the design, creation and testing of clinical study databases. 
    • Direct the activities related to creation of and adherence to to Data Management timelines and budget.
    • Able to perform a thoroughly detailed review of eCRF data requirements.
    • Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, and vendor specifications.  
    • Lead the creation and review of eCRFs, annotated eCRF, eCRF completion guidelines and Data Management Plans detailing complete data management processes throughout clinical studies.
    • Identify and assess vendors for data warehousing solutions to manage cross-study and cross-program data over time.

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • PhD or Master’s degree.
    • Minimum of 7 years in clinical and drug development in the pharmaceutical/biotech industry (10 years at the Master’s level) including regulatory submission/approval experience.
    • Previous participation at meetings with FDA and/or other regulatory agencies (eg End of Phase 2, Pre-NDA, Advisory Committee).
    • Strong understanding of drug development from pre-IND through NDA.
    • Advanced knowledge of statistical methods in clinical development including strong working knowledge of statistical software and data visualization packages such as SAS, nQuery, J-Review, etc.
    • Strong knowledge on the creation of protocols, SAPs, clinical study reports, integrated summaries of efficacy/safety.
    • Experience in management of CROs, multiple vendors, and complex protocols.
    • Experience in CNS/Neurology and experience with orphan indications preferred.
    • Understands the scope and focus of clinical trials phase 1-4 and has a proven ability to perform the tasks, manage vendor resources and timelines.
    • Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management, programming and statistics practice. Knowledge of and experience with MedDRA and WHODrug data dictionaries.  Working knowledge of CDISC standards.
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Strong team player that has a customer service approach and is solution oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication skills.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of SAGE.

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    Principal Accountabilities

    Sage Therapeutics is searching for a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program executive experience leading early to late stage drug development programs.l Scope and Summary

    Roles and Responsibilities

    • Define and articulate clear strategic vision within program teams
    • Operational leader for the product development/early development projects and serve as visible program champion and focal point for critical program information
    • Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
    • Set and maintain focus on overall program objectives and milestones but knowledgeable of supporting detail (tasks, associated expert resources and expense)
    • Drives decision point planning and associated deliverables across all functions of the team and contributes to the Sage portfolio planning process on behalf of the program(s)
    • Ensures the input from sub-teams to support the advancement of the program’s objectives and deliverables
    • Perform full program planning and execution within team environment
    • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
    • Proposes resource needs for program
    • Develop and own budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.
    • Program Status Reporting - ensure program is viable and aligned with corporate strategy
    • Accountable for meeting targets and managing deliverables
    • Issue Identification and Resolution
    • Cross-Functional Coordination and Communication including senior management
    • Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • Advanced degree and 15+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct project/program management experience in preclinical and clinical development, ideally honed through a combination of portfolio prioritization, working within a medical affairs organization (or similar) with emphasis on discovery to early development transition
    • Demonstrated knowledge of overall drug discovery and drug development processes relevant to pharmaceutical/biotech organizations as evidenced by multiple successful drug discovery program leadership experience
    • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
    • Capable of managing multiple programs/brands simultaneously
    • Previous experience with portfolio management concepts preferred; must have advanced planning and tracking skills with attention to detail including experience with project management and tools (i.e., MS Project)
    • Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
    • Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors
    • Possesses strong written and verbal communication skills
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Excitement about the vision and mission of SAGE

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