Senior Director, Head of PV Science
Alnylam Pharmaceuticals
August 11, 2026
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
Hybrid role; on-site presence required 2 days/week in Cambridge (preferred) or Philadelphia.
Responsibilities
- Lead PV Science and Aggregate Reports teams (PV Scientists/Fellows and aggregate report specialists).
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk across investigational and marketed products.
- Partner with Head of MSRM on strategy, process improvements, scenario planning, portfolio prioritization, budgeting, and forecasting.
- Collaborate across study teams and stakeholders; implement and monitor process enhancements.
- Ensure effective PV Scientist participation in Investigator and Site Initiation meetings.
- Develop/oversee SOPs, work practices, and training for Patient Safety and Risk Management.
- Support audits/inspections and manage corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (SRMT/SRMT Chairs/ESB); direct meeting material and ensure action-item completion.
- Lead signal detection via global medical literature monitoring.
- Oversee DSUR/PSUR and Development Risk Management Plans; serve as SME during inspections/audits.
- Oversee line listings production and timely submissions; coordinate Health Authority communications for DSURs/PSURs.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant science.
- 12+ years pharma; 8+ years drug safety/pharmacovigilance; 5+ years managing teams. RNAi therapeutics/rare disease global experience preferred.
Required/Preferred Skills
- Strong leadership/team building; PV regulatory expertise (US/EU/LATAM/APAC, incl. device safety).
- Safety operations knowledge; Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics).
- Matrix leadership, planning/organization/budgeting, excellent written/oral communication.
- Regulatory inspection readiness; process improvement; analytic/scientific interpretation.
Benefits (as stated)
- Medical/dental/vision; life/disability; lifestyle reimbursement; flexible spending/HSAs; 401(k) with match; paid time off, wellness days, holidays, two recharge breaks; family resources and leave.
Responsibilities
- Lead PV Science and Aggregate Reports teams (PV Scientists/Fellows and aggregate report specialists).
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk across investigational and marketed products.
- Partner with Head of MSRM on strategy, process improvements, scenario planning, portfolio prioritization, budgeting, and forecasting.
- Collaborate across study teams and stakeholders; implement and monitor process enhancements.
- Ensure effective PV Scientist participation in Investigator and Site Initiation meetings.
- Develop/oversee SOPs, work practices, and training for Patient Safety and Risk Management.
- Support audits/inspections and manage corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (SRMT/SRMT Chairs/ESB); direct meeting material and ensure action-item completion.
- Lead signal detection via global medical literature monitoring.
- Oversee DSUR/PSUR and Development Risk Management Plans; serve as SME during inspections/audits.
- Oversee line listings production and timely submissions; coordinate Health Authority communications for DSURs/PSURs.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant science.
- 12+ years pharma; 8+ years drug safety/pharmacovigilance; 5+ years managing teams. RNAi therapeutics/rare disease global experience preferred.
Required/Preferred Skills
- Strong leadership/team building; PV regulatory expertise (US/EU/LATAM/APAC, incl. device safety).
- Safety operations knowledge; Argus Safety Database and signaling tools (e.g., Empirica, PV Analytics).
- Matrix leadership, planning/organization/budgeting, excellent written/oral communication.
- Regulatory inspection readiness; process improvement; analytic/scientific interpretation.
Benefits (as stated)
- Medical/dental/vision; life/disability; lifestyle reimbursement; flexible spending/HSAs; 401(k) with match; paid time off, wellness days, holidays, two recharge breaks; family resources and leave.