Director, Medical Affairs Framework

Role Summary

The Director, USMA Framework Architecture is responsible for establishing, maintaining and continuously improving the medical affairs framework within US Medical Affairs. This role ensures medical affairs operates ethically, transparently and in full compliance with internal policies, industry codes and regulatory requirements. This role oversees the design and implementation of robust medical mechanisms for medical content, scientific exchange, evidence generation and external engagement to uphold the highest ethical standards, patient-centricity, and scientific integrity.

Responsibilities

• Identify and share opportunities to improve specific Medical Affairs framework, policies and input into relevant global and local policies.
• Develop, lead, and continuously improve the U.S. Medical framework to support compliant medical operations and decision-making.
• Drive medical affairs framework and ethical training programs and ensure ongoing training within USMA and US Affiliate as required.
• Ensure appropriate onboarding of employees into USMA framework in collaboration with Global Learning and Development.
• Ensure an effective medical contribution to the review and approval processes for U.S. promotional and non-promotional materials, ensuring medical accuracy and compliance (PRC).
• Ensure an effective medical contribution to the U.S. Medical Review Committee (MRC), ensuring timely and compliant review of medical content.
• Manage the USMA input into PRC and MRC escalation
• Collaborate closely with U.S. Commercial, Regulatory, Legal, and Compliance teams to support business objectives while upholding medical affairs framework standards.
• Ensure adherence to U.S. regulatory and industry standards including FDA promotional guidelines, PhRMA Code, and OIG compliance requirements.
• Provide medical governance oversight for U.S. medical field activities (e.g., MSL engagements, scientific exchange, advisory boards, investigator-sponsored studies).
• Support audits and inspections as needed.
• Up to date on emerging global and U.S. regulatory, clinical, ethical and compliance trends and assess their impact on USMA framework.
• Act as key liaison between Medical Affairs, Regulatory, Legal, Compliance and Commercial teams to ensure medical affairs has the optimal framework to enable compliance and USMA deliverables.
• Oversee risk assessments and implement control measures for emerging issues and manage medical and scientific risks across the US Affiliate.
• Develop appropriate metrics and dashboards to reflect key performance indicators for effective Medical Affairs framework within the US.

Qualifications

• BS/BA degree with 12+ years of experience or MS/MA degree with 10+ years of experience or PhD/PharmD with 8+ years of experience or MD with 4 years of experience
• Advanced degree in a life science discipline (MD, PharmD, or PhD strongly preferred).
• Minimum 5 years of experience in U.S. Medical Affairs roles within the pharmaceutical or biotech industry.
• Deep understanding of US FDA regulations, PhRMA Code, Sunshine Act, and other applicable laws and guidance.
• Proven understanding or ability to lead governance frameworks within a US-based, cross-functional Medical Affairs environment.
• Strong experience in promotional review committees and medical content governance.
• Exceptional interpersonal, influencing, and communication skills.
• Strategic mindset with the ability to navigate complex challenges and drive ethical, compliant decision-making.