Gastrointestinal & Inflammation (GI2) Therapeutic Area Head (TAH), Global Medical Safety (Vice President)
Takeda
August 25, 2026
Remote friendly (Boston, MA)
United States
$321,000 - $504,460 USD yearly
Medical Affairs
Objective / Purpose
- Accountable for end-to-end safety and benefit–risk strategy across the Therapeutic Area (TA), ensuring integrated, science-driven decision-making across GI2 development and marketed products.
- Defines and drives the global vision for patient safety within the TA.
- Serves as a senior enterprise decision-maker shaping Safety Board/executive governance outcomes (go/no-go, labeling, development strategy).
- Builds and leads a high-performing, future-ready safety organization.
Accountabilities
- Owns and is accountable for the TA-wide benefit–risk profile; integrates internal/external data to drive evidence-based decisions impacting development and regulatory positioning.
- Leads interpretation of complex safety signals/emerging risks; directs proactive/reactive response strategies and oversees Safety Management Teams (SMTs) to drive aligned safety recommendations.
- Shapes enterprise decisions (go/no-go, study design, risk tolerance, labeling), balancing patient safety with scientific/business considerations.
- Provides central leadership at Safety Board and other enterprise bodies; ensures decision-ready safety narratives and cross-functional alignment.
- Leads high-impact regulatory interactions with Health Authorities.
- Leads/ develops multi-layered safety organization (EMDs, SMDs, GSLs, PV Scientists) including talent strategy, org design, and succession planning.
- Drives adoption of advanced analytics and AI-enabled approaches.
- Mentors and develops GSLs and PV Scientists.
- Interfaces with cross-functional partners to ensure integrated lifecycle product strategy.
- Represents organization externally (regulators, advisory boards, partners) and leads/oversees safety due diligence for business development.
- Ensures excellence in pharmacovigilance (signal detection, risk management, regulatory submissions) and high-quality regulatory contributions; maintains compliance with global pharmacovigilance regulations/standards and inspection readiness.
Education & Competencies (Technical and Behavioral)
- M.D. or D.O. (or equivalent) ideally with Ph.D./Master in healthcare or Public Health.
- Direct clinical patient care experience.
- 10+ years in Pharmacovigilance, Clinical Research, or Clinical Development in pharmaceutical industry/academia/CRO, including global PV organization experience.
- 3+ years people management.
- Knowledge of drug safety regulatory requirements and methodologies; ability to synthesize complex data.
- Experience in multi-disciplinary and international drug development across therapeutic areas.
- Experience managing outsourced partners (CROs/vendors).
- Strong communication, analytical judgment, time management, leadership, mentoring, and global cross-functional collaboration.
Travel Requirements
- Up to 15% domestic/international travel.
Compensation & Benefits
- U.S. base salary range: $321,000.00–$504,460.00; may be eligible for incentives and listed insurance/benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires).
Hybrid Work
- Position is classified as “hybrid” per company policy.
Application Instructions
- Apply via the “Apply” button; acknowledge application processing and data use per Privacy Notice and Terms of Use.
- Accountable for end-to-end safety and benefit–risk strategy across the Therapeutic Area (TA), ensuring integrated, science-driven decision-making across GI2 development and marketed products.
- Defines and drives the global vision for patient safety within the TA.
- Serves as a senior enterprise decision-maker shaping Safety Board/executive governance outcomes (go/no-go, labeling, development strategy).
- Builds and leads a high-performing, future-ready safety organization.
Accountabilities
- Owns and is accountable for the TA-wide benefit–risk profile; integrates internal/external data to drive evidence-based decisions impacting development and regulatory positioning.
- Leads interpretation of complex safety signals/emerging risks; directs proactive/reactive response strategies and oversees Safety Management Teams (SMTs) to drive aligned safety recommendations.
- Shapes enterprise decisions (go/no-go, study design, risk tolerance, labeling), balancing patient safety with scientific/business considerations.
- Provides central leadership at Safety Board and other enterprise bodies; ensures decision-ready safety narratives and cross-functional alignment.
- Leads high-impact regulatory interactions with Health Authorities.
- Leads/ develops multi-layered safety organization (EMDs, SMDs, GSLs, PV Scientists) including talent strategy, org design, and succession planning.
- Drives adoption of advanced analytics and AI-enabled approaches.
- Mentors and develops GSLs and PV Scientists.
- Interfaces with cross-functional partners to ensure integrated lifecycle product strategy.
- Represents organization externally (regulators, advisory boards, partners) and leads/oversees safety due diligence for business development.
- Ensures excellence in pharmacovigilance (signal detection, risk management, regulatory submissions) and high-quality regulatory contributions; maintains compliance with global pharmacovigilance regulations/standards and inspection readiness.
Education & Competencies (Technical and Behavioral)
- M.D. or D.O. (or equivalent) ideally with Ph.D./Master in healthcare or Public Health.
- Direct clinical patient care experience.
- 10+ years in Pharmacovigilance, Clinical Research, or Clinical Development in pharmaceutical industry/academia/CRO, including global PV organization experience.
- 3+ years people management.
- Knowledge of drug safety regulatory requirements and methodologies; ability to synthesize complex data.
- Experience in multi-disciplinary and international drug development across therapeutic areas.
- Experience managing outsourced partners (CROs/vendors).
- Strong communication, analytical judgment, time management, leadership, mentoring, and global cross-functional collaboration.
Travel Requirements
- Up to 15% domestic/international travel.
Compensation & Benefits
- U.S. base salary range: $321,000.00–$504,460.00; may be eligible for incentives and listed insurance/benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires).
Hybrid Work
- Position is classified as “hybrid” per company policy.
Application Instructions
- Apply via the “Apply” button; acknowledge application processing and data use per Privacy Notice and Terms of Use.