Senior Director, Head of PV Science
Alnylam Pharmaceuticals
June 29, 2026
Remote friendly (Cambridge, MA)
United States
$245,500 - $332,100 USD yearly
Medical Affairs
Responsibilities:
- Lead PV Science (PV Scientists/Fellows) and Aggregate reports specialists; provide strategic lifecycle leadership for product safety profiles.
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk.
- Partner with Head of MSRM on process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate report production.
- Collaborate with study teams and cross-functional partners/vendors; implement and monitor process enhancements.
- Ensure effective PV Scientist participation in Investigator and Site Initiation meetings.
- In partnership with Head of MSRM: scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting.
- Lead development of SOPs, work practices, and training for Patient Safety and Risk Management.
- Participate in audits/inspections; manage corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (SRMT/SRMT Chairs/ESB) and direct meeting material; ensure timely action items; contribute to safety discussions.
- Lead signal detection via global medical literature monitoring.
- Oversee creation of Development Risk Management Plans (DRMPs) and SME contributions; coordinate cross-functional updates to Risk Management Plans.
- Aggregate Reports: assess insourcing vs outsourcing/AI capabilities/geographic readiness; oversee DSUR and PSUR planning/production/submission and related health authority communications; oversee line listing production/submissions; serve as SME during inspections/audits.
Qualifications:
- MD/PharmD/RN or master/doctorate in medical/healthcare or relevant scientific discipline.
- 12+ years pharma industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams.
- Advantage: global RNAi therapeutics and rare disease experience.
- Extensive PV/regulatory knowledge (US/EU/LATAM/APAC; incl. device safety regulations) and safety operations (case processing, aggregate reports).
- Strong matrix leadership; business process improvement ability.
- Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics).
- Regulatory inspection readiness experience.
- Strong planning, organization, budgeting, and written/oral communication.
- Adaptable, collaborative, and able to lead change.
Skills (Special):
- Primary internal/external contact for PV Science; lead cross-functional briefings/technical meetings; strong negotiation; analytic and scientific data interpretation.
Benefits:
- Medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off/wellness days/holidays, recharge breaks, family resources/leave.
Application instructions:
- Hybrid role: on-site presence 2 days/week (Cambridge preferred or Philadelphia offices).
- Lead PV Science (PV Scientists/Fellows) and Aggregate reports specialists; provide strategic lifecycle leadership for product safety profiles.
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk.
- Partner with Head of MSRM on process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate report production.
- Collaborate with study teams and cross-functional partners/vendors; implement and monitor process enhancements.
- Ensure effective PV Scientist participation in Investigator and Site Initiation meetings.
- In partnership with Head of MSRM: scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting.
- Lead development of SOPs, work practices, and training for Patient Safety and Risk Management.
- Participate in audits/inspections; manage corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (SRMT/SRMT Chairs/ESB) and direct meeting material; ensure timely action items; contribute to safety discussions.
- Lead signal detection via global medical literature monitoring.
- Oversee creation of Development Risk Management Plans (DRMPs) and SME contributions; coordinate cross-functional updates to Risk Management Plans.
- Aggregate Reports: assess insourcing vs outsourcing/AI capabilities/geographic readiness; oversee DSUR and PSUR planning/production/submission and related health authority communications; oversee line listing production/submissions; serve as SME during inspections/audits.
Qualifications:
- MD/PharmD/RN or master/doctorate in medical/healthcare or relevant scientific discipline.
- 12+ years pharma industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams.
- Advantage: global RNAi therapeutics and rare disease experience.
- Extensive PV/regulatory knowledge (US/EU/LATAM/APAC; incl. device safety regulations) and safety operations (case processing, aggregate reports).
- Strong matrix leadership; business process improvement ability.
- Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics).
- Regulatory inspection readiness experience.
- Strong planning, organization, budgeting, and written/oral communication.
- Adaptable, collaborative, and able to lead change.
Skills (Special):
- Primary internal/external contact for PV Science; lead cross-functional briefings/technical meetings; strong negotiation; analytic and scientific data interpretation.
Benefits:
- Medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off/wellness days/holidays, recharge breaks, family resources/leave.
Application instructions:
- Hybrid role: on-site presence 2 days/week (Cambridge preferred or Philadelphia offices).