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Career postings for the Massachusetts Biotechnology Council

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    Partner with the Head of Clinical Development, Head of R&D, and Business Unit Head to lead, drive, and grow the TA Portfolio. Provides strategic and operational direction for Global Clinical Development, including scientific and medical aspects of Phase II-IV clinical trials and specific post-marketing studies. Lead the global TA R&D development project teams and coordinate with the commercial team, to establish strategic direction and global product lifecycle management for TA pipeline and products. Ensure optimization of the TA portfolio, including the assessment of both internal and external therapeutics. Strategic R&D partner to the Business Units and provide scientific and medical perspective to the global TA strategy.

    Responsibilities include: Progression of Clinical Development candidates within the TA. TA Strategic leadership. Business Development. Culture and people leadership.

    Education & Experience Requirements
    * MD degree with board certification or equivalent in a medical specialty.
    * A seasoned R&D leader with 10+ years of drug development experience, early through late stage development, including the design and conduct of Phase 1-4 clinical studies. Experience with multiple therapeutic modalities, principally small molecules and biologics, would be preferred.
    * Experience in the due-diligence/in-licensing arena.
    * Credibility within the international medical and scientific community. Demonstrated links and strong industry contacts with thought leaders/centers in the Neuroscience therapy area.
    * Excellent interpersonal and communication skills. Ability to act as company spokesperson or scientific witness as needed.
    * International experience is preferable.
    * Experience with drug devices and companion diagnostics would be preferable.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.


    Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuODI0OTcuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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  • 12/22/15--22:33: Registry Manager
  • Primary Role: Registry Manager is responsible for managing or supporting the management of Registry Outcome Surveys conducted within the Global Clinical development Group. This individual may lead cross functional team members to appropriate and timely completion of registry-related projects; may oversee project timeline development and maintenance. Internally interfaces with data management and biostatistics, CRO's, CRAs, and will be a liaison with investigators and clinical site staff.

    Responsibilities:

    50%:
    * Candidate will have experience in managing some aspects of Registry outcomes from start-up to close-out activities to assure adherence to intended timeline to achieve survey goals while ensuring compliance in accordance with FDA, EMA, GCP, and ICH guidelines.
    * Candidate will have experience in coordinating interdisciplinary activities involving study/site start-up: investigator meeting planning, case report form development, informed consent deve
    lopment, development of contracts and budgets and study manuals
    * Together with the Registry Lead, create and implement a strategy for the registry.
    * Candidate will support Registry Lead in activities to ensure Global Regulatory Objectives/Commitments are properly prioritized.
    * Together with the Registry Lead, coordinate and manage activities for OS globally, such as: o Point of contact for sites o Reviewing monitoring reports from OMV and RMV o Participate in OS internal meetings o Production of study material/documents o Production of training material o Preparation of slide decks o Tracking of registry activities e.g. contracts, ICF, EC/IRB submissions, decision logs. o Filing of registry documents in RMF and eRMF o Planning and preparing for Board Meetings, Investigator's Meeting, Working Group Meetings
    * Encourage active participation and involvement of OS physicians in Global regions. Together with Registry lead and Global Medical Affairs, identify and develop new OS centers and KOLs
    * Support data completion initiatives for the OS Centers
    * Participate in and conduct visits and meetings with investigative sites, physicians and consultants, as needed

    30%:
    * Oversee contract organizations to help in the execution of the Registries. Contribute with the selection and management of contractors and third parties for work conducted by Shire Outcome Survey group and ensure successful conduct of Outcome Surveys by managing daily activities including timelines to ensure data integrity and quality
    * In close relationship with the CRO and OS Data Manager, ensure high quality and completeness of the data.
    * May Plan and implement resource allocations (both people and financial) to the individual surveys and activities of the department in collaboration with the Registry Outcomes Team Lead or Registry Lead.

    Assuring effective resource utilization in line with the department priorities:
    10%:
    * Work with marketing and commercial colleagues on strategies for supporting products during their life cycle, identifying research to support sales and ensuring its execution

    5%:
    * Maintain awareness of global HEOR requirements, regulatory legislation, payor trends & requirements

    5%:
    * May develop standard global processes and procedures to support health outcomes work practices
    * Stay current with developments in Registry Outcomes Indications Education & Experience Requirements:
    * Scientific/health care field preferred but not required.
    * A background with demonstrated success in clinical project management in the pharmaceutical industry
    * Experience managing GCP studies (both clinical and post-market)
    * Experience with observational databases preferred
    * Strong Organizational, IT and writing skills, as well as strong attention to detail
    * Experience in building relationships with physicians/centers, in particular KOLs
    * Experience in managing external expert groups Other Job Requirements: Up to 20% travel domestic and international About Shire: Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMTEwNDkuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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  • 12/22/15--22:36: Lead Medical Writer
  • Primary Role:
    The Lead Medical Writer (MW) is responsible for medical writing activities for a program (eg, a compound with one indication or single indication within a compound or several compounds if scope is small). With some oversight, provides strategic direction to cross-functional project team to ensure that clinical documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. Lead development of quality deliverables (development, review, approval) that are scientifically rigorous, logically organized, and accurate data presentation and interpretation. Activities (performed with some oversight) include, but are not limited to, writing, development of timelines, project management of the MW deliverables, participation on project team. May mentor less experienced writers. Generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration.

    The Lead MW reports to a Medical Writing Group Lead.

    Responsibilities:
    85%: Leading the MW activities for assigned project(s) including writing key deliverables.
    15%: Leading or participating on non-project related initiatives

    Education & Experience Requirements:
    * Advanced degree in a relevant scientific/clinical/regulatory field preferred;
    * Bachelor's degree required.
    * 5-7 years experience in clinical/pharmaceutical development with directly related medical writing experience.
    * Global regulatory submission experience preferred.

    Key Skills, Abilities, and Competencies:
    * Ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
    * Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW)
    * Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups
    * Ability to manage work timelines within assigned program(s).
    * Strong written presentation skills and ability to present information to others
    * Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues)
    * Ability to interact effectively with team members/leaders
    * Ability to assess issues and develop potential solutions
    * Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP)
    * Working knowledge of the regulatory guidances regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs)
    * Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook.
    * Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.

    Other Job Requirements: Less than 5% travel

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMzUwNTMuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Role:
    * Providing leadership and management within Clinical Development (CD) to provide medical and scientific support for products within assigned therapy area.
    * Support development and execution of medical & clinical strategy for assigned Shire product(s).
    * Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
    * Provide primary medical leadership in execution of clinical trials
    * Partner with other Shire functions to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements.
    * Acting as a senior company representative interacting with external scientific leaders and/or Regulatory authorities.
    * Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
    * Co-chair of the safety review team for assigned products
    * This position may be combined with the GCDL position when the program is limited in its scope and complexity

    Education & Experience Requirements:
    * M.D. degree (required); specialty training and certification (preferred)
    * Generally has at least six (6) years of experience in the Pharmaceutical Industry with relevant industry experience (clinical development).
    * Demonstrated ability to collaborate in a matrixed environment
    * Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
    * Experience in designing and conducting Phase 1-3 clinical trials; and/or
    * Significant late-stage development research.

    Other Job Requirements:
    * Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results. Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts. Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMjY4OTUuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Role:
    * Drives clinical activities of one or more Programs including life cycle management (LCM) and co-leads the development operations team (DOT)
    * In collaboration with the DOT, defines clinical strategy (clinical development plan, CDP) which is aligned with the Program strategy as defined by the global development team (GDT)
    * Responsible for the benefit/risk clinical assessment, in collaboration with the safety review team (SRT); reports to GDT major safety issues and proposes adaptation accordingly; ensure together with PV leader the delivery of key safety documents (e.g., Risk Management Plan)
    * Participates on the Global Medical Team as the GCDL
    * Co-chair of the safety review team (SRT)
    * Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
    * Provide primary medical leadership in execution of clinical trials
    * Partner with other Shire functions to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements.
    * Acting as a senior company representative interacting with external scientific leaders and/or Regulatory authorities.
    * Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.

    Education & Experience Requirements:
    MD required with at least 2 years experience in Clinical Research in the Pharmaceutical or Biotech industries. Experience conducting phase 2 or 3 studies required. Experience in Ophthalmology and/or training in Ophthalmology preferred.

    Other Job Requirements: A substantial amount of domestic and international travel (up to 30%) is required.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMTUwODAuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Duties :
    * Serve as a field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establish strong professional relationships, provide credible scientific expertise and serve as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs (GMA)
    * Support local team disease area and product knowledge through scientific training

    Responsibilities:
    50%:
    KOL Relationship Management
    * Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain “peer-to-peer” scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Ensures appropriate scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading
    * Provide scientific liaison support to Investigators currently involved in Shire's interventional or observational studies and investigator sponsored trials
    * Serve as a liaison between HCPs and Shire medical affairs

    25%:
    Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate in local medical and cross-functional initiatives
    * Provide field-based medical support to Shire's clinical research programs, registries, and facilitation of the investigator sponsored trials process
    * Communicates key medical insights from KOLs/HCPs to inform refinement of medical strategy
    * Gains customer insights, opinions and feedback and engages with internal colleagues to connect business opportunities with internal resources

    15%:
    Mentoring and Project Management Activities
    * Generates new ideas and constantly searches for novel applications of development plan strategies and tactics
    * Fosters teamwork within the area to achieve strategic objectives
    * Encourages an environment leading positive performance among colleagues and internal customers, and supports both individual and overall program success
    * Is a mentor for other MSL team members
    * Assist and augment training development of regional field-based MSLs

    10%:
    Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquiries from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs

    Education and Experience Requirements:
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic research/experience or substantive patient care experience is required (3 years minimum)
    * Require minimum 36 months of experience as a field MSL
    * Demonstration of expertise in key skills and competencies

    Other Job Requirements:
    * Frequent travel is required. Availability to travel approximately 40-70% of time
    * Availability to attend meetings on holidays and weekends
    * Clean and valid driver's license

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL: http://www.aplitrak.com/?adid=amRpZXR6Ljc4NjA1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Duties :
    * Serve as a field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establish strong professional relationships, provide credible scientific expertise and serve as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs (GMA)
    * Support local team disease area and product knowledge through scientific training
    * Maintain personal expertise in relevant disease areas and MSL best practices

    Responsibilities:
    60%: KOL Relationship Management:
    * Through compliant scientific exchange, builds and maintains professional relationships with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain "peer-to-peer" scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Provide scientific liaison support to Investigators currently involved in the Shire's Company sponsored interventional or observational studies and investigator initiated trials
    * Serve as a liaison between healthcare practitioners (HCPs) and Shire medical affairs
    * Facilitate 1:1 and group scientific interactions with healthcare professionals
    * Participate in KOL planning

    30%: Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquiries from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs and Shire internal teams

    * Conducts therapeutic training for Sales and Medical colleagues upon request
    5%: Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate in local medical and cross-functional initiatives
    * Provide field-based medical support to Shire's clinical research programs, registries, and facilitation of the investigator sponsored trials process
    * Communicates key medical insights from KOLs/HCPs to inform refinement of medical strategies or tactics

    5%: Maintaining personal expertise in relevant disease areas and MSL best practices
    * Maintain knowledge base and scientific expertise on all assigned Shire disease areas and products
    * Develop and update knowledge of applicable pharmaceutical guidelines and regulations, including, but not limited to, ICH, GCP, PhRMA, DOJ, OIG, R&D Code of Ethical Practices and company policies

    Education and Experience Requirements:
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic experience/research or substantive patient care experience is required (2 years minimum)
    * Medical, clinical or research experience in the assigned disease area is preferred
    * Demonstration of expertise in key skills and competencies

    Other Job Requirements:
    * Frequent travel is required. Availability to travel approximately 40-70% of time
    * Availability to attend meetings on holidays and weekends
    * Clean and valid driver's license

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjYxMTg3LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 12/22/15--22:48: Development Director
  • Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    Development Directors drive early stage development projects to decision points on time, on scope and on budget.

    Development Directors provide project management to Development Teams within a highly matrixed organization, starting when compounds are selected and proceeding through Proof of Concept.

    Development Directors employ high quality, rigorous project management methodologies and approaches within project teams to drive project delivery to the required targets, ensuring that all projects are aligned across functional lines, and to the needs of the business and that all stakeholder needs are identified and met.

    Development Directors identify potential risks to delivery, and potential gains to project value, and guide the team to develop appropriate scenario assessments and solutions/decisions.

    Finally, Development Directors maintaining a detailed knowledge of the inter- dependencies of activities that are required to prosecute a project up to the Proof of Concept milestone at all stages of the product lifecycle.

    Responsibilities
    1. Development Strategy Planning & Options Development
    * Leads and coordinates development of integrated project plans ensuring alignment
    across lines and functions.
    Leads the process for evaluation and optimization of alternative development options / scenario planning.
    * Challenge team members to ensure optimal strategic and operational plans
    * Planning and scheduling of project activities and alignment utilizing learning from
    other projects
    * Minimize cycle times through experience, sharing of best practices and excellence in
    project planning

    2. Project management: Execution (time, budget, scope), Risk Analysis and Management
    * All aspects of timeline management, including follow up
    * Ensure that Line plans align with project plans and commercial objectives - potentially
    by setting up and leading one or more of the project sub-teams (e.g. operational sub-team).
    * Identifying opportunities and risks - highlights critical path activities, provide focus for
    acceleration, allows tracking to monitor hand-offs
    * Create and manage the risk management plan for all opportunities and risks
    * Outlines activities & inter-dependencies to progress the project

    3. Information and Communication Management - at project and portfolio level
    * Ensure that project databases are accurate and current routinely
    * Ensures effective, accurate and timely communication of project team endorsed status
    updates to the stakeholders with respect to the portfolio (resourcing, budget, timeline, etc).
    * Coordinates and contributes preparation of team documents (Development Strategy
    Documents, Transition agreements, project team agendas, minutes etc) and presentations as a means of communicating to the organization.

    4. Team Leadership & Effectiveness
    * Works with team leader (and HR if appropriate) to build and maintain the performance and effectiveness of the project team, including regular checks on team health and identification and resolution (including escalation to appropriate level) of team performance issues.

    Qualifications
    Education and Experience:
    * Advanced scientific or medical degree (PhD, PharmD or MD)
    * 8+ years in the Pharma Industry in a product development capacity, preferably in an oncology setting.
    * MBA is a plus.
    * PMP certification is a plus.

    Technical Skills Requirements:
    * Deep experience in team and matrix leadership
    * Deep knowledge of Drug Development Sciences
    * Proven track record of drug product development

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS4xODIzMC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The position is accountable for working with the Clinical Scientific Data Warehouse (CSDW) product owner and Operation Support Managers to provide value to business customers and align with overall Development Operations strategy. Work independently and within a team to develop clinical data solutions to support business needs. The ideal candidate has a strong technical background across multiple technologies related to data integration and extensive experience with the clinical trial process from data management through reporting.

    The role will focus on development of reports and visualizations to support clinical and data management functions, including safety and efficacy review, data quality oversight, adjudication review, etc. Utilizing a broad range of skills, the ideal candidate can interpret a protocol and statistical analysis plan, develop code (SAS) to create value added data sets and generate visualizations in Spotfire. This role will also support a Risk-Based Monitoring (RBM) project in large, multi-site clinical trials; a unique opportunity for a motivated and collaborative candidate to help us build a new capability within Pfizer.

    Responsibilities
    * Responsible for clinical programming to enable study teams to monitor various aspects of their trials, including data quality, primary endpoint and safety review
    * Drive discussions with study teams to extract the relevant requirements for data visualizations and reports that will support their needs.
    * Responsible for developing technical solutions to support business use of the Clinical Scientific Data Warehouse (CSDW) including design and implementation of data marts (data modeling, ETL) and the data access layer, development and management of the CSDW Global Library (standard code, templates, metadata)
    * Responsible for working with business and technical SMEs across the organization to collaborate on strategies to streamline clinical data integration and access
    * Responsible for representing CSDW in technical discussions with Information and Business Technology colleagues, Clinical Aggregation Layer (CAL) Data Providers and external vendors
    * Responsible for collaborating with SMEs across Development Operations to develop and implement tools and processes to ensure quality in our clinical data
    * Responsible for development and/or implementation of strategies for analytics to align with overall business strategies.
    * Coordinate with other departments to develop, manage and execute repeatable programs based on analytic findings
    * Develops visually compelling presentations that communicate the relevant insights to stakeholders in an easily consumable manner
    * Deploy advanced analytics and provide the support for the people using them. May lead analytical projects that support strategic business direction/decisions
    * May be required to support new business initiatives through demonstration of analytical capabilities
    * Support the development and implementation of new and existing statistical techniques for RBM
    * Interact with the external vendor(s) who are providing Risk Based Monitoring (RBM) support to Pfizer
    * Responsible for the business activities supporting implementation or integration of reporting and visualization tools
    * Develop and Implement processes, metrics & other measures to create, support and drive business analytic activities
    * Provide company representation on industry focus groups and forums that have leading edge insight into emerging innovations
    * Responsible for business strategies that visually integrate Pfizer internal and external data
    * Ensure all activities comply with relevant global regulatory requirements & SOPs

    Qualifications
    EDUCATION AND EXPERIENCE
    Minimum of a Bachelor's degree (B.A. or B.S.) in biological sciences, Statistics, or a related discipline with a comprehensive understanding of biomedical data and systems and the clinical trial process. Master's degree in Mathematics, Statistics or Computer Science or other quantitative experience is desired.

    TECHNICAL SKILLS REQUIREMENTS
    Desirable skills will include:
    * Excellent analytical skills with demonstrated ability to solve problems
    * Strong technical background with demonstrated knowledge of SAS and PL/SQL
    * Experience in data modeling, DB development and ETL tools (Informatica) is preferred
    * Strong oral and written communication and interpersonal skills to successfully build long-term relationships with colleagues and business partners.
    * Experience in various reporting and visualization platforms
    * Strong experience in the clinical trial process (data collection through reporting)

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Please apply at: Application URL: http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS4wNDc2MS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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  • 12/23/15--00:33: Research Associate
  • The MIT-Broad Foundry is a cutting-edge synthetic biology facility focused on streamlining genetic design. To do this, we develop high-throughput methods for the design, construction, and analysis of complex genetic programs. We are in search of an experienced Research Associate to join the Foundry team and execute the newly developed Synthetic biology protocols.

    The ideal candidate must possess excellent communication skills and be a resourceful problem-solver who is highly motivated and thrives in a fast pace environment. This will be an integral role in process scale-up and increasing throughput capacity by providing valuable insight and feedback as the process end user.

    OVERALL RESPONSIBILITY:
    The primary focus is on executing Synthetic Biology related protocols at the lab bench (e.g., Molecular Biology, Biochemistry, and instrument operation). The desire to take an active role in method improvement, through investigation of process failures and suggestions for enhancement, is expected and the capacity to solve problems is required.

    CHARACTERISTIC DUTIES:
    - Develop and execute protocols related to Molecular Biology, Biochemistry, microbial cell culture and high-throughput automation
    - Participate in assay development and optimization including generation/revision of SOPs and related documents
    - Proactively engage in process optimization
    - Attend group meetings share project plans, status and recommendations
    - Maintain accurate laboratory notebooks

    EDUCATION
    - Bachelor’s Degree in Molecular Biology/Biochemistry/Chemistry/Genetics/Biological Engineering or a related field with a minimum of 2 years laboratory experience post degree required (industry or academic). Masters Degree preferred.

    SKILLS-
    - Experience with Molecular Biology techniques including essential nucleic acid manipulation techniques (extraction/purification, cloning, assembly and analysis) required
    - Experience with microbial culture techniques are essential
    - Experience with Biochemistry/Chemistry assay execution for protein/chemical analysis essential
    - Experience with some or all of the following: automated liquid handling, colony picking, plate handling, microscopy
    - Experience with Next Generation Sequencing (NGS) and sample prep a preferred, Mass Spec experience a plus
    - Some course work and/or practical experience with basic Genetics to understand replication, transcription and translation components
    - Highly organized and able to simultaneously maintain accurate records for multiple projects and large datasets
    - Excellent communication skills and ability to effectively interact with all levels of staff
    - Must be able to work effectively in a team setting yet also be motivated to work independently on primary tasks once appropriate training is given
    - Basic computer skills including Microsoft Office and Google Drive documents, experience with LIMS and documentation/bug tracking packages a plus

    The Broad Institute will not offer visa sponsorship for this opportunity.

    EOE / Minorities / Females / Protected Veterans / Disabilities

    To apply for this position, please CLICK HERE


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    Infinity is seeking a highly motivated individual to join the Purchasing/Procurement team. In this role you will be responsible for working cross-functionally on all purchasing related activities including but not limited to purchase orders, order inquiry, order placement, fulfillment, follow up post-delivery and invoice payment.  In this heavily customer oriented position, you will work cross-functionally to provide high quality customer service to our research, development and general business functions. This is a contract role with the potential to convert to permanent.

     

    Responsibilities:

    • Provides support for assigned departments including assistance with general operational activities (administrative support, supplier evaluations, ad hoc projects such as research assistance, responding to queries, drafting & delivery of presentation materials).
    • Supports existing processes, and develop process improvements to enhance departmental productivity and efficiency.
    • Works with Strategic Sourcing and Legal team members as part of the contracting process (i.e. Purchasing Contracts, RFPs, RFQs) for all vendors.
    • Understands and communicates department policies and procedures, particularly related to Sarbanes-Oxley (SOX) requirements.
    • Resolves basic contract and purchase order differences with suppliers.
    • Partners with Accounts Payable on resolving any invoice discrepancies.
    • Reviews requisitions in accordance with business requirements and budgets.
    • Assists in preparing RFPs and soliciting competitive bids, quotations and proposals with pertinent specifications, terms and conditions for all goods.
    • Expedites deliveries and conduct follow-up procedures when necessary.
    • Maintains agreement files, equipment records and/or specifications.
    • Prepares periodic activity reports.
    • Assisting in organizing annual information on capital equipment, expenditures, service contract renewals, etc. for annual budget process.

    Qualifications

    The qualified individual will be a highly motivated self-starter that works well both in teams as well as independently. 

    • Bachelor or Associate Degree, or equivalent work experience, plus 3-5 years’ experience in functional area (e.g. purchasing, strategic sourcing, etc.) or related field.
    • Excellent verbal, written and oral communication skills.
    • Strong attention to detail.
    • Demonstrated success working in a team environment.
    • Flexibility and ability to react promptly to multiple short term deadlines and manage competing priorities.  Proven ability to manage multiple projects / tasks effectively.
    • Ability to function independently on basic research projects, including sourcing/procurement of equipment/supplies.
    • Strong computer skills required: Microsoft Word, Excel, Outlook and PowerPoint.
    • Knowledge of Oracle and various reporting tools or similar systems preferred.
    • Fundamental knowledge of Sarbanes-Oxley (SOX) in a biotech/pharmaceutical company preferred
    • Excellent customer service skills, both internally and externally.

    To apply, please visit our website at http://www.infi.com


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    Research Associate, Molecular Biology and Protein Expression at Equipoise Therapeutics

     

    The successful candidate will work with the Equipoise Therapeutics team to develop novel therapies that stimulate immune responses against both solid and hematologic cancers.

     

    Responsibilities:

    • Mammalian cell expression and purification of recombinant proteins
    • Molecular cloning to construct new proteins products
    • Perform biochemical, cell and molecular biology experiments
    • Culture of cancer cell lines and immune cells
    • Plan experiments and coordinate with others when needed
    • Generate, analyze, interpret, and present experimental data
    • Develop new assays and troubleshoot when needed
    • Manage daily work flow independently and seek advice when appropriate
    • Stay attentive but flexible with deadlines
    • Work collaboratively with the Equipoise team

     

    Qualifications:

    • B.S. or M.S. degree in biochemistry, molecular biology, or relevant field
    • 2+ years of relevant research experience, industry experience preferred
    • Strong background in biochemistry, cell and molecular biology, or cancer biology
    • Experience with protein expression, purification, and assay
    • Mastery of basic cell and molecular biology techniques and cell culture
    • Proficiency with data analysis methods and software
    • Strong organizational and record keeping skills
    • Ability to multi-task with a high attention to detail
    • Ability to work in concert with a team as well as independently
    • Excellent written and verbal communication
    • Self-motivated, conscientious, and enthusiastic about curing cancer

     

    Equipoise Therapeutics is a discovery-stage company that aims to stimulate immune responses against cancer. We are developing novel first-in-class therapeutics targeted at natural killer cells as well as other cells of the innate immune system. These therapies are designed to counterbalance immune suppressive factors present in the tumor microenvironment and mobilize anti-cancer immune responses. Our molecules are expected to be potent as single agents as well as in treatment combinations with existing cancer immunotherapies. Our scientific founders are major figures in cancer biology and immunology and have launched Equipoise to effectively harness the power of the immune system to provide durable cancer treatments for patients.

     

    Please send your cover letter and resume to: join@equipoisetherapeutics.com.

    Updated December 21, 2015.

     

    Equipoise Therapeutics | One Kendall Square | Bldg 200, Suite 2203 | Cambridge, MA 02139 | equipoisetx.com


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    JOB OPPORTUNITY – Laboratory Technician / Viral Vector Lab Operations

     

    Company Description

    Addgene is a thriving, non-profit company that facilitates biomedical research and discovery. Addgene assists scientists by archiving their plasmid DNA samples and distributing these samples to researchers who need them for future experiments. Broad availability of these unique research materials promotes both the progress of research and Addgene’s mission to increase collaboration in the scientific community.

     

    Addgene has helped scientists share plasmids since 2004, and is now exploring new ways to serve the research community. We will begin producing ready-to-use virus from our popular plasmids to make it easier for scientists to conduct their experiments. We are seeking a Laboratory Technician to assist with viral production and laboratory operations.  

     

    Addgene is a dynamic and collaborative workplace. Our energetic team is dedicated to making a difference within the organization and in the larger scientific community. We support team building activities outside of work, including volunteer projects, social gatherings, and sporting events. This is a terrific opportunity become part of a young, growing company and to contribute to an important resource for the scientific community.

     

    Learn more about us at www.addgene.org/careers

     

    Job Description

    As a Laboratory Technician at Addgene you will perform a wide range of activities, including:

    • Produce lentiviral and AAV particles from expression plasmids

    • Determine titer and conduct quality control of viral particles

    • Package and ship DNA and viral samples to scientists around the world

    • Organize and track samples during production and storage

    • Test and optimize protocols for production and quality control of viral particles

    • Conduct DNA preparations and quality control of individual plasmids and pooled plasmid libraries

    • Support lab operations, including inventory management, solution preparation, and standard lab tasks

    • Assist with basic research as relevant

    • Lead and participate on special projects as needed, including working with other teams at Addgene

     

    Job Qualifications

    • Candidates should be self-motivated, organized individuals who want to be a part of Addgene’s mission. Specific qualifications include:

    • B.S. (preferred) or B.A. in biological sciences OR an Associates’ degree with 2-3 years’ experience in a laboratory environment

    • Excellent organizational skills and attention to detail

    • Familiarity with pipetting and using sterile technique

    • Experience with tissue culture and viral production preferred

    • Familiarity with general computer software, including MS Office and web applications

     

    Start Date

    First quarter of 2016

     

    Job Location

    Addgene is located at 75 Sidney Street in Cambridge, MA.  It is close to MIT, walking distance from the Red Line, and parking is available.

     

    Compensation

    Salary commensurate with experience. Benefits include health and dental insurance, company-subsidized parking and/or public transportation, and annual professional development allowance.

     

    Applications

    Please send cover letter and resume to jobs@addgene.org.  Only applications with a cover letter AND resume will be considered.


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    Our privately held biopharmaceutical company is seeking an innovative, motivated and scientifically curious Senior Research Associate looking to make a difference by contributing their knowledge and expertise in cellular biology to their talented team. This candidate needs to hit the ground running and be able to get up to speed quickly on new techniques.

    REQUIREMENTS:

    • BS/MS with 5-10 years industry experience
    • Strong background in cellular biology with skills in cellular assay development and cell signaling
    • Ability to generate and manipulate stable cell lines
    • An autonomous role where you can generate your own data, present to the project team, and drive further research
    • A truly unique company with an excellent work environment!

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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  • 12/23/15--09:56: Senior Program Manager
  • We are working closely with an innovative and successful commercial drug development company located in Cambridge MA who is seeking a motivated, goal-oriented individual to join their Program Management team. This company exhibits a unique sense of culture, and this opportunity will give the right applicant the chance to part of an amazing, collaborative team working towards creating medicines.

    The right fit for this position will play a crucial part in supporting the drug development teams quest to bring inventive new life changing human medicines to the market. This key hire will provide leadership, coordination & cross-functional communication to help all teams meet and exceed their goals.

    The perfect fit for this position will be an excellent communicator, possessing strong conflict resolution skills, a scientific background and a strong knowledge and experience in clinical stage drug development, including hands on oversight of programs from an IND submittal into phases 1-3.  A PMP certification is preferred, but not required. 

    Requirements:

    • A 4-year degree and a minimum of 3-5 years of relevant work experience
    • Strong communication, presentation and cross-functional management experience a need
    • Strong experience in project planning tools, content management systems, and Microsoft Office Suite. 
    • Budget development and tracking experience

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™

     


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    Laboratory Director, Quality Control Laboratory

    Requirements:

    Thorough knowledge of the principles of organic, inorganic and physical chemistry and microbiology, including qualitative and quantitative analysis. Must have working knowledge of chemical laboratory procedures, techniques, instrumentation, equipment and laboratory safety. Must be proficient in instrument analysis, including semi volatile and volatile organics analysis (VOA), chromatography (HPLC, LC/MS, GC, GC/MS), spectrophotometry, microbiological, and metals analysis through ICP-OES or ICP-MS.

    Ideal candidate will have:

    • Masters or PhD in Chemistry, Biochemistry or related field
    • 3+ yrs of industry experience
    • Experience in laboratory management
    • Mastery of HPLC, HPLC/MS/MS, GC and GC/MS techniques
    • Proficiency in ICP-MS or ICP-OES
    • Experience with USP methods Chapters 467, 233, 61, 62
    • Experience in ISO 17025 accreditation
    • Proficiency in laboratory instrumentation maintenance.

    Salary commensurate with experience. 

    Please send your cover letter and resume to: bob@cambridgebiolabs.com
    Updated December 23, 2015.


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  • 12/22/15--22:17: Sr. Clinical Project Manager
  • The Sr. Clinical Project Manager is responsible for the planning, implementation and conduct of large, complex clinical trials or multiple smaller studies across indications or development compound(s). The Sr. Clinical Project Manager is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables. 

    The Sr. Clinical Project Manager is also responsible for providing high quality personnel management and functional expertise so that individuals within his/her line are able to effectively contribute to the execution and delivery of projects and/or clinical trials in accordance with GCP, regulatory requirements, appropriate Vertex and/or CRO SOPs and Work Instructions, and Vertex policies. They will coach and develop staff to maximize their contributions to clinical trial execution, cross-functional drug development and process improvement activities, and the department. The line manager is expected to provide leadership within CDE and make recommendations with regards to resourcing, new process development, and process improvement to maximize GCP and corporate standards compliance, staff efficiency and growth, assist with employee training, development, and retention .

    Key Responsibilities:

    - Able to develop and execute complex study plans in one or more clinical studies with minimal supervision

    - Provides oversight and integration activities of all Clinical Operations staff supporting assigned projects

    - Able to draft plans for multiple related studies, with oversight

    - Develops study budget(s) with oversight

    - Accountable for managing performance of direct reports through consistent dialog

    - Responsible for ensuring employees adequately and in accord with Vertex management expectations oversee outsourced services to designated vendor partners.

    - Responsible for ensuring completion of the appropriate performance management activities; covering primary roles and responsibilities, goal setting in alignment with Clinical Development Execution and corporate goals, promoting Vertex values, competencies, and individual career development plans.

    - Ensures that employee relations are managed proactively and regularly to maximize the motivation and well-being of employees.

    - Ensures that employees are trained, developed, and coached so that their capabilities comply with company and regulatory requirements, maximizing their contribution to the projects and/or clinical trials and developing their skills and competencies in their respective roles.

    - Proactively manages project and resource issues that require attention on behalf of the department and liaises in consultation with the CDE Leadership to address and resolve resource issues.

    - Drives the implementation of process improvements and initiatives with the objective of enhancing GC compliance, efficiency, and productivity of staff.

    - Contributes to employee forums and incorporates feedback from individuals and the team to enhance knowledge sharing.

    - Shares insights and lessons learned across CDE and exCDE functions to ensure alignment.

    - Ensures internal compliance with Clinical Development SOP’s, guidelines and corporate compliance policies related to the clinical trial conduct aspects of GCP’s and other applicable regulations

    - Attends scientific meetings and builds relationships with Investigators, business partners

    - Participates in study data review and interpretation

    - Participates in and contributes to publication strategy and content

    - Assumes a lead role in the identification process of Investigators or vendors and assures proper prequalification of clinical sites

    - Ensures external and internal documentation prepared within the Clinical Operations function is completed in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials

    Position Qualifications:

    - M.S. (or equivalent experience) and 6+ years of relevant work experience

    -B.S. (or equivalent experience) and 8+ years of relevant work experience -Demonstrated Line/People Management Experience

    Managerial and Communicative Skills:

    - Displays highly developed leadership qualities

    - Deep understanding of Clinical Operations and Drug Development. Expert on assigned protocols

    - Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents

    - Proactively seeks out and recommends process improvements

    - Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight

    - Communicates clearly and effectively with internal and external key stakeholders

    - May contribute to Clinical Development Plans with some oversight

    - Consistently demonstrates overall leadership in Clinical Operations


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  • 12/22/15--22:37: Clinical Project Manager
  • Clinical Project Manager is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed.

    Key Responsibilities:
    • Responsible for developing and managing approved trial
    budget
    • Develops and oversees study operational plan(s).
    • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of
    assigned clinical trials.
    • Assists with protocol design and strategy and medical issue resolution.
    • Participates in study data review and assists with patient narrative writing and other data review activities as assigned.
    • Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports.
    • Proactively identifies project risks and resolves with some supervision.
    • Participates in the selection of Investigators and vendors.
    • May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel.
    • Represents Clinical Operations in cross-functional initiatives,
    as assigned by management, and may act on behalf of team.
    • Performs other duties as assigned.

    Minimun Qualifications:

    • M.S. and 4+ years of Project Manager experience in a Sponsor or CRO setting, or B.S. and 6+ years of Project Manager experience in a Sponsor or CRO setting.

    Preferred Qualifications:
    • Strong study management track record showing clear proficiency in clinical project management skills.
    • Solid vendor management skills.
    • Broad understanding of operations including those in related development functions.
    • Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development.
    • Demonstrates ability to effectively interface with key medical personnel at clinical site(s).
    • Demonstrates ability to lead multi-disciplinary teams.
    • Hands on Clinical Operations experience.
    • Have lead single or multiple studies.
    • Hands on Clinical Project Management.
    • Excellent written and verbal communication skills


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  • 12/22/15--22:51: Sr. Quality Manager
  • The Senior Quality Manager of Quality Assurance (QA) GCP is an independent contributor who is responsible for performing quality assurance activities to ensure that Vertex clinical trials are conducted in accordance with Good Clinical Practice guidelines, applicable regulations and Vertex policies and procedures. In addition, this position is responsible for adhering to the Vertex’s quality standards as set forth in the Quality Management System. The Senior Quality Manager is also responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks.

    General Responsibilities and Required Skills:


    • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice
    • Adheres to the QA department goals and ensures linkage to individual goals
    • Fosters Vertex Core Values when collaborating with cross functional teams
    • Provides GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects’ safety, rights, and wellbeing as well as the integrity and credibility of data generated.
    • Provides guidance and support to internal department in the form of SOP reviews and/or ad-hoc requests.
    • Establishes/maintains effective cross functional team communications to advance quality activities of Vertex while remaining independent and autonomous.
    • Performs other duties as assigned

    Key Responsibilities:


    • Responsible for developing a strategic audit plan for the development of assigned compounds and ensuring that audits are conducted in accordance with the plan according to the audit process as per and Vertex’s standards operating procedures (SOPs) and processes.
    • Leads domestic and international audits for Clinical Investigators and acts as the Lead Auditor Vendor Audits, Internal Process Audits and/or GCP Document Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and laws and Vertex SOPs.
    • Leads or participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause. Oversees appropriate Corrective Actions and Preventive Actions (CAPAs).
    • Assures reporting of potential or confirmed violations, as appropriate, in accordance with Vertex SOPs and processes.
    • As assigned, review and approve audit reports submitted
    by QA GCP Quality Managers for content, format, regulatory risks, and compliance with applicable standards. Promotes consistency of audit report writing.
    • Identifies and escalates critical quality issues appropriately to senior QA management.
    • Obtains audit responses from Vertex functional areas or vendors
    and evaluate proposed CAPAs for adequacy if implemented successfully in accordance with Vertex SOPs.
    • Ensures adequate and timely closure of CAPAs
    with supporting documented evidence in accordance with Vertex SOPs and processes.
    • Contributes to the development of continuous quality process
    improvements
    • Maintains and reports accurate and timely metrics associated
    with assigned compound or clinical development program as assigned
    • Provides inspectional support for Regulatory Inspections held at Vertex facilities or Clinical Investigator sites as needed.
    • Maintains current training in accordance with the QA GCP training curriculum
    • This position may require up to 30% travel.

    Minimun Qualifications:

    Master Degree in a scientific or allied health field with 4 + years or relevant GCP experience or B.S. in a scientific or allied health field and 9+ years of relevant GCP work experience, or relevant comparable background and 5 + years of relevant QA experience.


    • Advanced knowledge of FDA regulations, EU Directives, MHRA Statutory Instruments and ICH guidances
    • Understands the Clinical Development Phases of Drug Development
    • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
    • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables
    • Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building
    • Possess the necessary scientific education
    and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects, understands medical terminology, standards of care and disease states.
    • Understands the medical/therapeutic impact of investigational products
    • Demonstrates proficiency in negotiating skills and conflict resolution
    • Demonstrates advanced skills in the conduct
    of audits and the translation of findings into CAPAs that mitigate risks.
    • Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
    • Proficiency in using Microsoft Office applications is an asset (MS Word, MS Excel, MS Powerpoint


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    GENERAL SUMMARY/OVERVIEW STATEMENT:

    The mission of the Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Women’s Hospital, by building services helpful to clinical investigators and facilitating the success of individual investigators. CCI is organized into 6 programs, each led by a BWH faculty member. 

    Working independently and under supervision from the Senior Project Manager and Administrative Directors provides support to clinical research studies.  May be responsible for the following activities: overseeing and guiding the work of more entry level staff, and assisting on regulatory responsibilities of multiple research studies supported by the CCI.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    Coordinate and assist with all protocol submissions, preparation and submission of regulatory documents Assist with the submission regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA). Assist with the maintenance of various regulatory records and databases with information related to study recruitment, subject enrollment, and study completion. Maintains or assists in the maintenance of records on each study to ensure regulatory compliance with Partners policies as well as federal and ICH/GCP guidelines. Assist with preparation for and participate in monitoring visits by sponsor Train more junior staff on regulatory process and procedures Develop and document standard procedures for managing studies supported by CCI. Review and monitor progress of research studies Meet regularly with Medical Director, Manager, and CCI Administration. Initiate and monitor study start-up activities Participate in ongoing training and educational activities within CCI.  Participate in educational offerings and activities to maintain up to date knowledge of local and federal regulations and guidelines Responsible for providing support for CCI program development. Other duties as assigned

    QUALIFICATIONS:

    Bachelor’s degree required. 2 -3 years of work experience in clinical research, preferably actively coordinating human research trials. 1 year of regulatory compliance experience (FDA, IRB etc) preferred.

    SKILLS/ABILITIES/COMPETENCIES REQUIRED:

    Thorough knowledge and understanding of ICH/GCP guidelines and methodologies Sound independent judgment Excellent written and oral communication skills Ability to analyze information and problem solve Maintain confidentiality of information Demonstrate good decision-making and judgment Strong attention to detail and follow-through skills Demonstrated organization and time management/prioritization skills with the ability to work independently are required. Ability to effectively train and mentor

    Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.

     

    If you are interested in this position please apply to Job ID# 3008176 to the link below:

    http://www.brighamandwomens.org/About_BWH/Careers/external-candidate-job-listings.aspx?sub=0


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