Senior Medical Director - U.S. Medical Affairs
No salary listed
Senior
PharmD, PhD, MD
Boston, MA, USA
HybridFour days on-site per week, Monday through Thursday.
Biology & Biotech
About the job
Requirements
- An advanced clinical or scientific degree (MD, DO, PharmD, or PhD) is required; MD or DO is preferred.
- At least 7 years of relevant Medical Affairs experience in the biotechnology or pharmaceutical industry, with progressive responsibility and demonstrated medical leadership.
- Deep scientific and medical expertise in rare diseases, including understanding rare disease treatment landscapes, clinical development, and unmet medical needs.
- Significant experience leading development and execution of U.S. Medical Affairs strategy, preferably for commercial-stage products, with demonstrated ownership of medical plans and initiatives.
- Strong experience in scientific exchange, key opinion leader engagement, medical communications, and evidence generation.
- Ability to critically evaluate and interpret complex clinical data and translate scientific insights into actionable medical strategies.
- Experience collaborating cross-functionally with Commercial, Market Access, Patient Advocacy, and other internal stakeholders.
- Demonstrated leadership capabilities and interest in managing and developing a field-based Medical Science Liaison team alongside broader corporate Medical Affairs responsibilities.
- Excellent communication, strategic thinking, and relationship-building skills, with the ability to operate effectively in a dynamic, growing biotechnology environment.
Responsibilities
- Develop, lead, and execute the U.S. Medical Affairs strategy for MIPLYFFA, aligning it with organizational priorities, evolving scientific evidence, and the needs of patients and healthcare professionals.
- Serve as a senior medical and scientific expert in Niemann-Pick disease type C, maintaining a deep understanding of the disease landscape, clinical data, treatment considerations, and emerging scientific developments.
- Provide medical leadership and scientific guidance across U.S. Medical Affairs initiatives, including medical education, scientific communications, evidence generation, and external engagement.
- Establish and maintain relationships with key opinion leaders, healthcare professionals, investigators, and other external scientific stakeholders to facilitate scientific exchange and identify unmet medical needs.
- Lead and support evidence generation initiatives, including Phase IV studies, registries, investigator-initiated studies, real-world evidence initiatives, and expanded access programs, as appropriate.
- Partner cross-functionally with Commercial, Market Access, Patient Advocacy, and other internal stakeholders to provide medical expertise and support compliant, scientifically sound business initiatives.
- Review scientific publications, abstracts, presentations, medical education materials, promotional and non-promotional content, reimbursement dossiers, and payer-related materials as a medical reviewer.
- Support development and execution of medical communications and educational initiatives to advance understanding of Niemann-Pick disease type C, MIPLYFFA, and the broader rare disease landscape.
- Provide medical and scientific input into payer engagement activities, including communicating clinical evidence and developing scientifically accurate resources supporting patient access.
- Translate scientific developments, external stakeholder insights, and emerging clinical evidence into actionable recommendations that inform U.S. Medical Affairs priorities.
- Provide leadership and oversight to the U.S. field-based Medical Science Liaison team, including coaching, mentoring, performance management, and professional development.
- Ensure field medical activities and scientific engagement strategies align with U.S. Medical Affairs objectives and are executed with scientific rigor and compliance.
- Partner with Medical Excellence to establish and evaluate appropriate metrics, field medical insights, and performance indicators to support continuous improvement.
- Provide medical expertise and scientific training to internal teams, including field medical and cross-functional stakeholders, as appropriate.
- Maintain scientific integrity, ethical conduct, and compliance with applicable regulatory requirements, industry standards, and company policies.
Desired Qualifications
- Experience leading U.S. Medical Affairs strategy for commercial-stage products is preferred.
- MD or DO is preferred.
- Prior people management experience is preferred.
About the company
Zevra Therapeutics develops and commercializes therapies for rare diseases, focusing on CNS disorders with unmet needs. It grows its portfolio through in-house development and strategic acquisitions, including OLPRUVA for urea cycle disorders (acquired via Acer Therapeutics) and azstarys, a once-daily ADHD treatment marketed in the U.S. with Corium. The company is advancing arimoclomol for Niemann-Pick disease type C and engages with the FDA to navigate approvals. Zevra earns revenue from product sales, royalties, and milestone payments from its partnerships, and aims to build a differentiated portfolio that serves underserved patient populations.
Company Size
51-200
Company Stage
IPO
Headquarters
Boston, Massachusetts
Founded
2006
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Simplify's Take
What believers are saying
- Q2 2026 revenue hit $39.7 million, up 53% year over year.
- Cash reached $260.2 million June 30, 2026, after debt repayment and asset sale.
- Q2 2026 prescription enrollment reached 184, with 69% covered-life access.
What critics are saying
- EMA rejected arimoclomol in 2026; re-examination can still fail again.
- MIPLYFFA drove $30.2 million of Q2 2026 revenue, creating single-product dependence.
- If Europe stays closed, Zevra loses its biggest near-term expansion pathway.
What makes Zevra Therapeutics unique
- MIPLYFFA won FDA approval September 20, 2024, for Niemann-Pick disease type C.
- Zevra owns orphan and Orange Book protection for MIPLYFFA through 2041.
- The 270-patient NPC dataset gives Zevra unmatched long-term real-world evidence.
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Benefits
- Wellness Program
- Remote Work Options