Senior Director, Head of Medical Review
Takeda
August 21, 2026
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Medical Affairs
Senior Director, Head of Medical Review (Hybrid) — Cambridge/Boston, MA
Position Objectives
- Oversee medical assessment of individual case safety reports (ICSRs) for investigational and marketed products across therapeutic areas.
- Ensure high-quality medical assessment in the Global Safety Database and compliance with domestic/international regulations.
- Lead and manage global medical review; provide medical oversight for outsourced medical review.
- Guide harmonization of medical assessment for LOC-originated cases.
- Manage medical review physicians and oversee vendor staff.
- Ensure medical reviewers are trained to perform ICSR medical review per company SOPs and guidelines.
Position Accountabilities
- Provide strategic leadership and oversight for medical review and case assessment.
- Develop/author/maintain/approve procedural documents, templates, training materials, and toolkits.
- Ensure compliance with ICH/GCP and applicable regulations for patient safety.
- Drive cross-functional collaboration (peer function, cross-functions, quality; PSPV operations/medical safety; vendor safety).
- Conduct process impact assessments for regulatory requirement changes; lead initiatives improving medical review activities/processes.
- Support inspections/audits and implement CAPA.
- Review safety sections of clinical trial protocols, investigator brochures, and informed consents (selected programs).
Education/Experience/Skills
- Medical degree (or equivalent).
- 15+ years pharmaceutical/healthcare industry experience; 3+ years post-graduate patient clinical experience.
- 15+ years pharmacovigilance experience incl. medical review of ICSRs.
- Strong knowledge of US/EU/MHRA drug safety regulations, CIOMS, ICH guidelines.
- Reference Safety Information updates experience (e.g., IB, CCDS, local labels).
- People leadership; manage matrix teams; global/international collaboration.
Compensation/Benefits (U.S.)
- Base salary range: $212,000–$333,190.
Application Instructions
- No phone calls or recruiters please.
Position Objectives
- Oversee medical assessment of individual case safety reports (ICSRs) for investigational and marketed products across therapeutic areas.
- Ensure high-quality medical assessment in the Global Safety Database and compliance with domestic/international regulations.
- Lead and manage global medical review; provide medical oversight for outsourced medical review.
- Guide harmonization of medical assessment for LOC-originated cases.
- Manage medical review physicians and oversee vendor staff.
- Ensure medical reviewers are trained to perform ICSR medical review per company SOPs and guidelines.
Position Accountabilities
- Provide strategic leadership and oversight for medical review and case assessment.
- Develop/author/maintain/approve procedural documents, templates, training materials, and toolkits.
- Ensure compliance with ICH/GCP and applicable regulations for patient safety.
- Drive cross-functional collaboration (peer function, cross-functions, quality; PSPV operations/medical safety; vendor safety).
- Conduct process impact assessments for regulatory requirement changes; lead initiatives improving medical review activities/processes.
- Support inspections/audits and implement CAPA.
- Review safety sections of clinical trial protocols, investigator brochures, and informed consents (selected programs).
Education/Experience/Skills
- Medical degree (or equivalent).
- 15+ years pharmaceutical/healthcare industry experience; 3+ years post-graduate patient clinical experience.
- 15+ years pharmacovigilance experience incl. medical review of ICSRs.
- Strong knowledge of US/EU/MHRA drug safety regulations, CIOMS, ICH guidelines.
- Reference Safety Information updates experience (e.g., IB, CCDS, local labels).
- People leadership; manage matrix teams; global/international collaboration.
Compensation/Benefits (U.S.)
- Base salary range: $212,000–$333,190.
Application Instructions
- No phone calls or recruiters please.