Director, PV Science
Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information.
The Director PV Science works closely with the Senior Director/Executive Director of Global Patient Safety & Risk Management (GPSRM) to provide internal safety representation to the development teams and medical affairs colleagues, conduct review of partner scientific and medical deliverables, and conduct activities associated with structured benefit risk assessment of assigned drugs. This role contributes to the safety and benefit-risk evaluations for the developmental and marketed products, the management of potential safety issues, evaluation of safety signals, and other activities such as facilitating of responses to regulatory inquiries with regard to safety topics.
Summary of Key Responsibilities
Clinical Trial Safety:
Reviews clinical trial protocols, and other clinical study-related documents impacting patient safety
Reviews standard design of tables, figures and listings for safety data from clinical studies
Develops Safety Management Plans for clinical development programs
Reviews, documents, and escalates concerns and issues to GPSRM management
Provides input to the development of product Reference Safety Information, including Core Company Safety Information, Investigators Brochure, local labels, etc.
Contributes to the authoring of Clinical Study Report, Summary of Clinical Safety, Integrated Summary of Safety, etc.
Periodic (Aggregate) Safety Reporting:
Leads the activities related to the aggregate report preparation in collaboration with the functional areas, the external vendor and the medical writing team
Provides input and review for aggregate reports (i.e., DSUR, PSUR/PBRER) for submission to the health authorities and other stakeholders
Provides assistance with the preparation of responses to regulatory authority PSUR assessment reports
Signal Detection, Evaluation, and Management:
Performs proactive safety monitoring and signal detection for assigned products
Completes initial assessment of safety signals and prioritizes safety signals for full evaluation
Assists with full signal work-up and drafts the initial signal safety assessment and benefit risk evaluation report
Performs case series review or review of tabulated data in support of signal analysis or regulatory query responses
Provides support for the activities of the cross-functional Safety Management Team responsible for overseeing the safety of company products
Maintains schedules, minutes, tracking sheets and ensures follow-up of decisions and assigned tasks for relevant safety activities
Assists in the preparation of presentation materials and accompanying documents in support of the decision process within the safety governance
Risk Management and Minimization:
Coordinates activities relevant to the Development Risk Management Planning for the assigned product
Drafts section(s) of the initial Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) for assigned products, and oversees the maintenance of these documents
Assists in the preparation and review of safety assessments and evaluations for ad hoc regulatory safety reports, Health Hazard Assessments for recall determination and responses to inquiries from internal and external customers
Leads the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
Collaborates with Systems and Technical teams to establish expertise with data visualization tools (e.g. Empirica, Spotfire) to support safety data analysis
Education: Degree in a medical or healthcare related discipline (MD, PharmD, RN), or high qualification relevant to scientific or business discipline.
In depth knowledge of global clinical and post marketing safety regulations, guidances, and reporting processes
Experience: A minimum of seven to ten years in the pharmaceutical industry with experience in Global Patient Safety & Risk Management/pharmacovigilance. Previous experience in managing Global Patient Safety & Risk Management personnel a plus. Specific experience in rare diseases therapeutic area at a global level is an advantage.
Ability to perform the assigned safety activities in full compliance with applicable regulations and internal procedures
Ability to recognize opportunities and apply analytical and creative thinking to maximize company performance
Ability to focus on delivering excellent results and improving process by taking initiative, trying new approaches, and working cooperatively with safety colleagues and other functional areas
Ability to express ideas and information clearly and accurately. Excellent interpersonal, communication, and personal organization skills
Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
Job Complexity: Lead global signal management, risk management planning and aggregate data review. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management.
Supervision: Position will report directly to Executive Director of Global Patient Safety & Risk Management. Individual is expected to work independently with support from management and colleagues in Global Patient Safety & Risk Management department.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.