Senior Director, Head of PV Science

Manage teams of PV Scientists and Fellows, as well as the Aggregate report specialists Responsible for operationalizing PV Science department to provide continuous support in development, implementation and maintenance of a risk management system for detection, assessment and minimization of risk for investigational and marketed products Work closely with the Head of MSRM and safety leads analyzing MSRM team's needs and potential process improvements in all functions, including routine and ad-hoc signaling activities, clinical trial initiations, regulatory interactions, and aggregate reports production Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problem solving Implement and monitor process enhancements and improvements Manage participation of PV Scientists in Investigator meetings and Site Initiation meetings, ensuring effectiveness of the content delivery Responsible for ensuring the team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes. Participate in audits, inspections and quality improvement initiatives. Provide direction on relevant meeting material preparation Ensure timely completion of all action items Participate in relevant safety discussions providing scientific and operational contributions Responsible for signal detection through global medical Literature monitoring Responsible for SME contributions to initial Risk Management Plans Responsible for planning, production, and successful submission of PSURs. Education: Master or doctorate degree in a medical or healthcare related discipline (MD, PharmD, RN), or relevant scientific discipline. Experience: A minimum of 12 years in the pharmaceutical industry with a minimum of 8 years in drug safety/pharmacovigilance. A minimum of 5 years of experience in managing teams. Specific experience in RNAi therapeutics and rare disease areas at a global level is an advantage Strong leadership and team building skills with track record of team building and expansion Extensive knowledge of Pharmacovigilance and advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements including device safety regulations Extensive knowledge of safety operations, including but not limited to case processing and aggregate reports production Ability to work in a matrix environment in accordance with the company leadership commitments and values. Experience of working across diverse geographic areas, business settings and cultures strongly preferred Ability to apply business process improvement methodologies and/or developing ideas into practical business solutions Extensive knowledge of Argus Safety Database and Signaling tools (eg. Empirica, PV Analytics) Regulatory Inspection readiness experience Strong planning, organization, and budgeting skills Superb written and oral communication skills Adaptability and ability to approach change with positivity and foster a resilient environment Ability to foster collaboration within internal and external teams maintaining supportive and positive work culture Supervision: Individual is expected to work independently with support from management and colleagues in SRM. LI-JB1 #LI-Hybrid U.S. Pay Range $245,500.00 - $332,100.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

Biopharmaceutical company pioneering RNA interference (RNAi) therapeutics for rare genetic, cardiometabolic, and CNS diseases. Headquartered in Cambridge, MA.

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