Neuroscience Therapeutic Area Head (TAH), Global Medical Safety

Principal responsibilities include ensuring integrated, science-driven decision-making for safety and benefit–risk strategy across the Neuroscience Therapeutic Area (TA), both in development and for marketed products.

Responsibilities

• Defines and drives the global vision for patient safety within the TA, aligning safety strategy with asset strategy, regulatory expectations, and enterprise priorities.
• Serves as a senior enterprise decision-maker, shaping outcomes in Safety Board and executive governance forums, including impact on go/no-go decisions, labeling, and development strategy.
• Owns and is ultimately accountable for the TA-wide benefit–risk profile, integrating internal and external data to drive clear, evidence-based decisions impacting development strategy and regulatory positioning.
• Leads interpretation of complex safety signals and emerging risks, directing proactive and reactive response strategies, while overseeing Safety Management Teams (SMTs) and ensuring GSLs proactively identify risks and drive aligned, forward-looking safety recommendations across programs.
• Shapes enterprise-level decisions (e.g., go/no-go, study design, risk tolerance, labeling), ensuring the primacy of patient safety while balancing scientific and business considerations.
• Plays a central leadership role at Safety Board and other enterprise bodies, ensuring clear, decision-ready safety narratives and recommendations while driving cross-functional alignment.
• Leads high-impact regulatory interactions, including direct engagement with Health Authorities on complex safety and benefit–risk matters, anticipating regulatory implications and shaping response strategies.
• Leads and develops a multi-layered organization (EMDs, SMDs, GSLs, PV Scientists) with full accountability for talent strategy, organizational design, and succession planning.
• Establishes a culture of accountability, scientific rigor, and innovation, ensuring consistent excellence in safety strategy and execution across the TA.
• Drives capability advancement, including adoption of advanced analytics and AI-enabled approaches.
• Mentors and develops GSLs and PV Scientists, strengthening medical judgment and advancing scientific safety leadership across the organization.
• Serves as the primary safety leader interfacing with cross-functional partners, ensuring integrated product strategy across the lifecycle.
• Represents the organization externally with regulatory authorities, advisory boards, and partners, influencing external safety and benefit–risk positioning.
• Leads or oversees safety due diligence for business development, ensuring robust evaluation and integration of safety considerations into partnerships.
• Ensures excellence in core pharmacovigilance activities (signal detection, risk management, regulatory submissions), with focus on strategic interpretation and impact.
• Ensures high-quality safety contributions to global regulatory submissions and health authority interactions, supporting development and lifecycle management.
• Ensures compliance with global pharmacovigilance regulations and standards (e.g., FDA, EMA, PMDA, ICH, CIOMS), maintaining inspection readiness.
• Core member of the PSPV Leadership Team, contributing to strategic direction and operational excellence.
• Leads and/or contributes to executive initiatives across disciplines and functions, driving enterprise impact.

Requirements

• Medical Degree (M.D. or D.O.) required, or internationally recognized equivalent, ideally combined with an Advanced Degree (e.g., Ph.D./Master in a healthcare or Public Health discipline).
• Direct clinical patient care experience following post-graduate training and appropriate grounding and knowledge of general medicine.
• 10+ years of experience in Pharmacovigilance, Clinical Research, or Clinical Development within the pharmaceutical industry, academia, and/or CRO, including significant experience in a global pharmacovigilance organization.
• Minimum of 3 years’ experience in people management.
• Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.
• Ability to comprehend and synthesize complex data and experience in identifying, analyzing, and implementing programs and procedures to achieve corporate objectives.
• Experience operating in a multi-disciplinary drug development environment, including international experience and exposure to a variety of therapeutic areas.
• Experience working in an outsourced environment managing suppliers, CROs, vendors, and strategic partnerships.
• Identifies opportunities and anticipates changes in the medical safety landscape through ongoing assessment of the environment affecting patient safety.
• Develops partnerships with internal and external stakeholders to align with strategic objectives.
• Inspires commitment through effective communication (meetings, writing, presentations) and demonstrates integrity.
• Demonstrable experience in people management at a leadership level, with well-developed skills in team-building, motivating, empowering, and developing people.
• Works productively in a fast-moving and pressured environment.
• Strong analytical and judgment capabilities to understand, analyze, synthesize, and communicate complex information concisely.
• Well-developed time management skills to prioritize multiple issues.
• Computer literate, including safety database acumen.
• Self-resourced, with confidence to take initiative and act autonomously.
• Facilitates and efficiently leads meetings, both in person and via other media.
• Excellent oral and presentation communication skills.
• Proven ability to work globally and cross-functionally, with strong interpersonal skills, assertiveness, team orientation, and mentoring ability.

Travel Requirements

Up to 15% domestic and international travel may be required to support transformation activities, governance, inspections, audits, capability-center engagement, and business meetings.

Schedule

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Pay

For Location: Boston, MA, the U.S. base salary range is $321,000.00 - $504,460.00. The actual base salary offered may depend on factors including qualifications, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and location.

Benefits

• Eligibility for short-term and/or long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per calendar year.