Senior Director Medical Affairs

APX Life Sciences; Boston (MA); On-site; USD 210,000 - 320,000; Full time

Job summary

APX Life Sciences is seeking a strategic and experienced Senior Director, Medical Affairs to lead U.S. medical affairs activities during a pivotal transition from late-stage development toward launch preparation.

The role requires deep medical affairs expertise, strong scientific credibility, and hands‑on experience supporting major data readouts in fast‑moving environments, with responsibility for KOL engagement and cross‑functional leadership.

Qualifications

• Advanced scientific or medical degree required.
• 10+ years of Medical Affairs experience within biotech or pharmaceutical organisations.
• Proven experience supporting Phase 3 programs and/or major clinical data readouts.
• Pre-launch or launch experience strongly preferred.
• Demonstrated success in KOL engagement, advisory boards, and scientific exchange.
• Prior people leadership or matrix leadership experience preferred.
• Strong understanding of U.S. regulatory and compliance frameworks relevant to Medical Affairs.

Responsibilities

• Lead U.S. medical affairs strategy in alignment with clinical, regulatory, and commercial priorities.
• Drive medical planning and execution for topline and full data disclosures, including scientific interpretation and dissemination.
• Provide medical leadership for congress planning, publications, abstracts, and scientific presentations.
• Develop core scientific narratives, medical decks, FAQs, and reactive materials in a compliant manner.
• Build and maintain strong relationships with key opinion leaders, investigators, and external experts.
• Plan and facilitate advisory boards and scientific exchange engagements.
• Partner cross‑functionally with Clinical Development, Regulatory, Commercial, Market Access, and Communications teams.
• Support launch readiness through disease education, unmet‑need articulation, and evidence‑generation planning.
• Ensure all medical affairs activities adhere to U.S. regulatory, compliance, and industry standards.

Skills

Medical affairs leadership

KOL engagement

Regulatory compliance knowledge

Strategic thinking

Education

MD/DO/PharmD/PhD

Job description

APX Life Sciences is partnering with a growing biotech organisation is seeking a strategic and experienced Senior Director, Medical Affairs to lead U.S. medical affairs activities during a pivotal period of transition from late‑stage development toward launch preparation. This role is highly visible and will shape how key clinical data are interpreted, communicated, and translated into scientific and clinical impact.

The ideal candidate brings deep medical affairs expertise, strong scientific credibility, and hands‑on experience supporting major data readouts and pre‑commercial planning in dynamic, fast‑moving environments.

KEY RESPONSIBILITIES

• Lead U.S. medical affairs strategy in alignment with clinical, regulatory, and commercial priorities.
• Drive medical planning and execution for topline and full data disclosures, including scientific interpretation and dissemination.
• Provide medical leadership for congress planning, publications, abstracts, and scientific presentations.
• Develop core scientific narratives, medical decks, FAQs, and reactive materials in a compliant manner.
• Build and maintain strong relationships with key opinion leaders, investigators, and external experts.
• Plan and facilitate advisory boards and scientific exchange engagements.
• Partner cross‑functionally with Clinical Development, Regulatory, Commercial, Market Access, and Communications teams.
• Support launch readiness through disease education, unmet‑need articulation, and evidence‑generation planning.
• Ensure all medical affairs activities adhere to U.S. regulatory, compliance, and industry standards.

QUALIFICATIONS

Required:

• Advanced scientific or medical degree (MD, DO, PharmD, PhD, or equivalent).
• 10+ years of Medical Affairs experience within biotech or pharmaceutical organisations.
• Proven experience supporting Phase 3 programs and/or major clinical data readouts.
• Pre‑launch or launch experience strongly preferred.
• Demonstrated success in KOL engagement, advisory boards, and scientific exchange.
• Prior people leadership or matrix leadership experience preferred.
• Strong understanding of U.S. regulatory and compliance frameworks relevant to Medical Affairs.

Preferred:

• Strategic thinker with the ability to execute hands‑on in a lean, fast‑paced environment.
• Strong clinical and scientific acumen with excellent communication skills.
• Comfortable navigating ambiguity during high‑stakes milestones.
• Collaborative leader with a track record of effective cross‑functional partnership.

TRAVEL

Approximately 30–40%, including scientific meetings, advisory boards, and internal team engagements.