Gastrointestinal & Inflammation (GI2) Therapeutic Area Head (TAH), Global Medical Safety

Job Description

Objective /

Purpose:

Principal responsibilities include:

• 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, 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

• Builds and leads a high-performing, future-ready safety organization, advancing innovation and strengthening global capability in safety science and benefit–risk assessment

Accountabilities:

Enterprise Safety Strategy & Decision Making:

• 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

Governance Leadership & Executive Influence:

• Plays a central leadership role at Safety Board 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

Organizational Leadership & Capability Building:

• 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

Cross-Functional & External Leadership:

• 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

Operational Oversight with Strategic Impact:

• 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

Enterprise Leadership:

• 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

Education & Competencies (Technical and Behavioral):

• Medical Degree (M.D. or D.O.) required or internationally recognized equivalent ideally combined with 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…