Senior Director – Externally Sponsored Research & Medical Governance

Senior Director – Externally Sponsored Research & Medical Governance

Requirements

• Advanced scientific or medical degree (PhD, PharmD, MD) preferred; MS or equivalent experience in biomedical sciences or related field considered.
• 15+ years of experience in Medical Affairs and ISTs within the biotechnology or pharmaceutical industry.
• Proven ability to develop and execute medical education strategies aligned with company and scientific priorities.
• Strong expertise in grants governance, funding oversight, and compliance frameworks.
• Experience in IST program leadership, including proposal review, funding allocation, and study execution.
• Ability to navigate cross-functional partnerships with Legal, Compliance, Regulatory, and Clinical teams.
• Strong analytical and strategic thinking skills with the ability to assess educational and research proposals for scientific merit and alignment.
• Excellent communication, interpersonal, and presentation skills to engage internal and external stakeholders effectively.
• Strong background in Medical Governance, Compliance, Regulatory Affairs, or Medical Operations.
• Deep knowledge of global regulatory requirements for Medical Affairs, including FDA, EMA, ICH, GVP, and industry best practices.
• Proven experience developing SOPs, policies, and governance frameworks to support medical organizations.
• Strong track record in inspection readiness, audits, and compliance oversight for Medical Affairs functions.
• Ability to navigate complex regulatory and legal environments and advise teams on governance best practices.
• Experience leading Medical Review Committees (MRCs) or similar governance structures.

Responsibilities

• Develop and oversee the end-to-end ESR process, including proposal review, approval, funding, execution, and publication planning.
• Partner with cross-functional teams (Clinical Development, Medical Affairs, Regulatory, Legal, Compliance, Corporate Communications) to establish clear ESR governance, review criteria, and execution frameworks.
• Ensure that ESRs align with scientific and strategic objectives while maintaining compliance with regulatory and legal requirements.
• Monitor ongoing ESRs progress, ensuring milestone tracking, study reporting, and data dissemination.
• Develop strategies to optimize ESR program efficiency, including systematic tracking of proposals, funding allocations, and study outcomes.
• Serve as a key point of contact for ESR-related interactions with internal and external stakeholders.
• Work closely with Medical Affairs, Clinical Development, Commercial, and other teams to align research funding with strategic priorities.
• Build relationships with external medical and scientific communities, including medical societies, KOLs, and academic researchers.
• Ensure timely and transparent communication with investigators, maintaining strong external partnerships.
• Develop and implement a comprehensive Medical Governance framework to support strategic and operational excellence across Medical Affairs.
• Lead governance process for the Medical Affairs, including facilitation and coordination of the Medical Project Review Group.
• Oversee the medical review responsibilities and process for Medical Legal Review committees, including MRC, ensuring efficient and compliant medical review of materials, communications, and scientific content.
• Ensure medical activities align with corporate policies and external regulatory guidance, including FDA, EMA, PhRMA Code, ICH, GVP, and other relevant regulations.
• Establish, maintain, and optimize Medical Affairs Standard Operating Procedures (SOPs), work instructions, and best practices to drive consistency and compliance.
• Conduct periodic reviews of policies and ensure Medical Affairs teams are trained on key processes.
• Lead inspection readiness efforts across Medical Affairs, ensuring processes, documentation, and governance frameworks meet regulatory expectations.
• Act as a point of contact for regulatory inspections and internal audits, providing oversight and guidance on Medical Affairs-related compliance activities.
• Collaborate with QA and Compliance to identify risks, implement corrective and preventive actions (CAPAs), and maintain audit readiness.
• Work across therapeutic areas, geographies, and functions to ensure seamless integration of governance processes within the Medical Affairs organization.
• Provide strategic guidance to Medical Affairs leadership on governance best practices and risk mitigation strategies.
• Act as the key liaison between Medical Affairs, Compliance, Legal, and other internal stakeholders to align governance initiatives across the organization.

Preferred Qualifications

• Prior experience in oncology, precision medicine, or targeted therapies.
• Experience leading medical education initiatives and research collaborations in a global biotech/pharma environment.
• Familiarity with digital tools and platforms for medical education tracking, grant submissions, and IST management.
• Ability to optimize IME, grants, and IST processes for scalability and operational efficiency.