Head of Medical Affairs

Position Overview

Our client is seeking a strategic and hands-on Head of Medical Affairs to lead the development and execution of global medical strategy supporting its regenerative medicine portfolio. This individual will serve as a key member of the leadership team, building and scaling Medical Affairs capabilities while ensuring scientific excellence, cross-functional alignment, and strong engagement with external stakeholders.

The ideal candidate brings deep expertise in Medical Affairs within biotech/pharma, preferably with experience in orthopedics, regenerative medicine, or advanced therapies, and a proven ability to operate in a pre-commercial to early commercialization environment. This role will be fast-paced and grant the opportunity to support a product launch and build a Medical Affairs team from the ground up, partnering directly with C-suite leadership.

Key Responsibilities

Medical Strategy & Leadership

• Develop and execute the global Medical Affairs strategy, aligned with corporate and commercial objectives
• Build and lead the Medical Affairs function, including Medical Science Liaisons (MSLs), Medical Communications, and Field Medical teams
• Serve as a key strategic advisor to executive leadership on clinical, scientific, and medical matters
• Prepare the organization for product launch readiness, including medical strategy for commercialization

Scientific & External Engagement

• Establish and maintain relationships with Key Opinion Leaders (KOLs), investigators, and academic institutions
• Lead scientific exchange and ensure accurate, compliant dissemination of clinical and real-world evidence
• Represent the company at major medical congresses (e.g., AAOS, ACR, ASCO where applicable) and advisory boards
• Support the development and execution of Investigator-Initiated Trials (IITs) and collaborative research

Evidence Generation & Data Strategy

• Oversee the generation of Real-World Evidence (RWE), HEOR, and post-marketing data to support product value
• Collaborate with Clinical Development on life-cycle management strategies, including new indications and label expansion
• Guide publication strategy, ensuring timely and high-impact dissemination of data

Cross-Functional Collaboration

• Partner closely with Clinical Development, Regulatory, Commercial, Market Access, and Pharmacovigilance teams
• Provide medical input into regulatory submissions, promotional materials, and payer engagement strategies
• Ensure alignment between global and regional medical activities

Compliance & Governance

• Ensure all Medical Affairs activities adhere to regulatory, legal, and compliance standards (FDA, OIG, PhRMA)
• Establish and maintain standard operating procedures (SOPs) and governance frameworks
• Serve as a medical signatory where applicable

Qualifications

Education & Experience

• MD, PharmD, or PhD in a relevant life sciences field required
• 10+ years of experience in biopharma/biotech, with significant leadership experience in Medical Affairs
• Prior experience supporting product launch(es) strongly preferred
• Background in orthopedics, musculoskeletal disorders, regenerative medicine, or cell/gene therapy highly desirable

Core Competencies

• Demonstrated ability to build and scale Medical Affairs functions in emerging or growth-stage companies
• Strong scientific acumen with the ability to translate complex data into clear clinical value propositions
• Proven track record of KOL engagement and external stakeholder management
• Experience working in cross-functional, matrixed environments
• Excellent leadership, communication, and organizational skills

Key Success Factors

• Strategic mindset with the ability to execute tactically in a fast-paced biotech environment
• Ability to influence across all levels of the organization
• Strong balance of scientific rigor and business acumen
• Track record of driving impact in pre-commercial or early commercialization settings