Senior Director, Head of PV Science
Alnylam Pharmaceuticals
June 26, 2026
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
Responsibilities
- Lead PV Science department (PV Scientists/Fellows) and Aggregate Reports specialists; provide strategic leadership for safety profiles across product lifecycle.
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk for investigational and marketed products.
- Partner with Head of MSRM and safety leads to drive process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate reporting.
- Collaborate with study teams and cross-functional groups; implement/monitor process enhancements.
- Manage PV Scientist participation in Investigator/Site Initiation meetings; ensure timely action items.
- Lead scientific ways of working: develop SOPs/work practices and training for Patient Safety and Risk Management.
- Participate in audits/inspections; drive corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (e.g., SRMT, ESB meetings) and meeting material direction.
- Lead signal detection via global medical literature monitoring.
- Oversee Development Risk Management Plans (DRMPs) and SME contributions to Risk Management Plans.
- Manage aggregate report readiness, planning/production/submission of DSURs and PSURs, line listings, and communications with health authorities.
- Serve as SME for Aggregate Reports during inspections/audits.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant scientific discipline.
- 12+ years pharmaceutical industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams; global RNAi/rare disease experience a plus.
Required/Preferred Skills & Experience
- Leadership/team building; strong PV and global regulatory knowledge (US/EU/LATAM/APAC) incl. device safety; safety operations/aggregate report production.
- Matrix working across geographies; business process improvement; Argus Safety and signaling tools (e.g., Empirica, PV Analytics).
- Regulatory inspection readiness; planning/organization/budgeting; strong written/oral communication; adaptability; collaboration.
- Special: primary contact for PV Science services; lead cross-functional technical briefings; negotiation; analytic/scientific data interpretation.
Benefits
- Comprehensive benefits including medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, and 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Work Location
- Hybrid; 2 days/week onsite in Cambridge (preferred) or Philadelphia.
- Lead PV Science department (PV Scientists/Fellows) and Aggregate Reports specialists; provide strategic leadership for safety profiles across product lifecycle.
- Operationalize PV Science risk management system for detection, assessment, and minimization of risk for investigational and marketed products.
- Partner with Head of MSRM and safety leads to drive process improvements across signaling, clinical trial initiations, regulatory interactions, and aggregate reporting.
- Collaborate with study teams and cross-functional groups; implement/monitor process enhancements.
- Manage PV Scientist participation in Investigator/Site Initiation meetings; ensure timely action items.
- Lead scientific ways of working: develop SOPs/work practices and training for Patient Safety and Risk Management.
- Participate in audits/inspections; drive corrective actions with Global Safety Operations and other functions.
- Oversee safety committee functioning (e.g., SRMT, ESB meetings) and meeting material direction.
- Lead signal detection via global medical literature monitoring.
- Oversee Development Risk Management Plans (DRMPs) and SME contributions to Risk Management Plans.
- Manage aggregate report readiness, planning/production/submission of DSURs and PSURs, line listings, and communications with health authorities.
- Serve as SME for Aggregate Reports during inspections/audits.
Qualifications
- Master’s or doctorate in medical/healthcare (MD, PharmD, RN) or relevant scientific discipline.
- 12+ years pharmaceutical industry; 8+ years drug safety/pharmacovigilance; 5+ years managing teams; global RNAi/rare disease experience a plus.
Required/Preferred Skills & Experience
- Leadership/team building; strong PV and global regulatory knowledge (US/EU/LATAM/APAC) incl. device safety; safety operations/aggregate report production.
- Matrix working across geographies; business process improvement; Argus Safety and signaling tools (e.g., Empirica, PV Analytics).
- Regulatory inspection readiness; planning/organization/budgeting; strong written/oral communication; adaptability; collaboration.
- Special: primary contact for PV Science services; lead cross-functional technical briefings; negotiation; analytic/scientific data interpretation.
Benefits
- Comprehensive benefits including medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, and 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Work Location
- Hybrid; 2 days/week onsite in Cambridge (preferred) or Philadelphia.