Senior Director, Head of Medical Review
Takeda
11 days ago
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Medical Affairs
Senior Director, Head of Medical Review (Hybrid)
Position Objectives:
- Oversee medical assessment of individual case safety reports (ICSRs) for investigational and marketed products across therapeutic areas.
- Ensure high-quality ICSR medical assessment in the Global Safety Database in compliance with domestic and international regulations.
- Lead and manage global medical review; provide medical oversight for outsourced medical review.
- Ensure processes and activities comply with ICH, FDA, EMA, and MHRA requirements.
- Provide guidance to harmonize medical assessment of LOC-originated cases.
- Manage a team of medical review physicians; oversee vendor staff performing medical review.
- Ensure medical reviewers are trained per company SOPs and guidelines for ICSR review.
Position Accountabilities:
- Provide strategic leadership and oversight for medical review and case assessment.
- Develop/author/maintain/approve procedural documents, templates/forms, training materials, and toolkits.
- Ensure compliance with domestic/international regulations and ICH/GCP for patient safety.
- Communicate with internal/external stakeholders and manage queries.
- Collaborate with peer, cross-functional, and Quality stakeholders with PSPV Operations/Medical Safety and Vendor Safety.
- Lead process impact assessments for regulatory changes and implement required updates.
- Improve medical review activities/processes; support inspections/audits and CAPA.
- Monitor best practices/industry trends/technology/vendor landscape.
- Ensure staff/vendor meet KPIs for quality and timeliness.
- Review safety sections of clinical trial protocols, investigator brochures, and informed consents.
- Perform other duties as requested.
Education & Skills:
- Medical degree required (or equivalent).
- USMLE/ECFMG/COMLEX-USA/FLEX preferred.
- 15+ years industry experience; 3 years post-graduate clinical/patient experience.
- 15+ years pharmacovigilance experience with ICSR medical review.
- Knowledge of US/EU/MHRA drug safety regs, CIOMS, ICH.
- Experience updating Reference Safety Information (IB, CCDS, local labels).
- People leadership; manage matrix teams; strong strategic/planning/execution/communication.
- Global/international collaboration experience.
- Clinical development operational experience.
Compensation/Benefits (U.S.):
- Base salary range: $212,000–$333,190.
- Possible incentives and benefits may include medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time, holidays, well-being, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application Instructions:
- Apply via Takeda’s “Apply” button (no phone calls or recruiters).
Position Objectives:
- Oversee medical assessment of individual case safety reports (ICSRs) for investigational and marketed products across therapeutic areas.
- Ensure high-quality ICSR medical assessment in the Global Safety Database in compliance with domestic and international regulations.
- Lead and manage global medical review; provide medical oversight for outsourced medical review.
- Ensure processes and activities comply with ICH, FDA, EMA, and MHRA requirements.
- Provide guidance to harmonize medical assessment of LOC-originated cases.
- Manage a team of medical review physicians; oversee vendor staff performing medical review.
- Ensure medical reviewers are trained per company SOPs and guidelines for ICSR review.
Position Accountabilities:
- Provide strategic leadership and oversight for medical review and case assessment.
- Develop/author/maintain/approve procedural documents, templates/forms, training materials, and toolkits.
- Ensure compliance with domestic/international regulations and ICH/GCP for patient safety.
- Communicate with internal/external stakeholders and manage queries.
- Collaborate with peer, cross-functional, and Quality stakeholders with PSPV Operations/Medical Safety and Vendor Safety.
- Lead process impact assessments for regulatory changes and implement required updates.
- Improve medical review activities/processes; support inspections/audits and CAPA.
- Monitor best practices/industry trends/technology/vendor landscape.
- Ensure staff/vendor meet KPIs for quality and timeliness.
- Review safety sections of clinical trial protocols, investigator brochures, and informed consents.
- Perform other duties as requested.
Education & Skills:
- Medical degree required (or equivalent).
- USMLE/ECFMG/COMLEX-USA/FLEX preferred.
- 15+ years industry experience; 3 years post-graduate clinical/patient experience.
- 15+ years pharmacovigilance experience with ICSR medical review.
- Knowledge of US/EU/MHRA drug safety regs, CIOMS, ICH.
- Experience updating Reference Safety Information (IB, CCDS, local labels).
- People leadership; manage matrix teams; strong strategic/planning/execution/communication.
- Global/international collaboration experience.
- Clinical development operational experience.
Compensation/Benefits (U.S.):
- Base salary range: $212,000–$333,190.
- Possible incentives and benefits may include medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time, holidays, well-being, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application Instructions:
- Apply via Takeda’s “Apply” button (no phone calls or recruiters).