Medical Director (Pharmacovigilance) in Boston, Massachusetts at Zevra Therapeutics, Inc.

About Zevra Therapeutics, Inc.

We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies.

With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients.

Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients’ lives.

About the role

Zevra Therapeutics is a commercial-stage rare disease company committed to improving the lives of patients with serious, underserved conditions. We are seeking an experienced and strategic Medical Director, Pharmacovigilance to provide medical and scientific leadership for pharmacovigilance and product safety across our marketed and development-stage portfolio.

The Medical Director will serve as a key internal and external representative of Pharmacovigilance, with responsibility for the ongoing evaluation and management of the safety profiles of MIPLYFFA® (arimoclomol), our FDA-approved therapy for Niemann-Pick disease type C (NPC), and celiprolol, currently in Phase 3 development for vascular Ehlers-Danlos syndrome (VEDS). This role requires experience spanning both post-marketing pharmacovigilance and clinical development safety.

This individual will lead safety surveillance, signal evaluation, benefit-risk assessment, safety governance, and risk management activities across assigned products. Operating within a lean organization, the Medical Director will combine strong medical and scientific judgment with strategic leadership and a broad understanding of the pharmacovigilance function, bringing together internal and external resources to support effective safety oversight and decision-making.

The Medical Director will partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, the Qualified Person for Pharmacovigilance (QPPV), and senior leadership, and will represent Pharmacovigilance in interactions with health authorities, external partners, and other key stakeholders.

This position will operate onsite 4 days/week (Monday - Thursday) at our Boston HQ.

KEY RESPONSIBILITIES

Product Safety Leadership

• Serve as the medical safety lead for MIPLYFFA and celiprolol, providing safety leadership across post-marketing and clinical development settings.
• Lead ongoing benefit-risk assessment and safety surveillance, integrating clinical, post-marketing, real-world, literature, and other relevant safety data.
• Lead and provide medical oversight of signal detection, evaluation, management, and communication, ensuring emerging safety issues are appropriately assessed, escalated, and addressed.
• Lead and participate in safety governance forums, representing the PV perspective and providing clear medical and scientific recommendations to cross-functional stakeholders and senior leadership.
• Provide strategic safety input into clinical development, regulatory submissions, labeling, risk management, and commercialization activities.

Regulatory & Cross-Functional Leadership

• Serve as a senior medical representative for Pharmacovigilance, effectively communicating safety strategy, emerging risks, benefit-risk assessments, and recommendations to internal and external stakeholders.
• Provide medical leadership for key safety deliverables, including DSURs, PBRERs/PADERs, RMPs, signal assessments, and safety-related regulatory submissions and responses.
• Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, and other functions to ensure safety considerations are integrated into product strategy and decision-making.
• Serve as a key medical partner to the QPPV, ensuring alignment on emerging safety issues, benefit-risk assessments, risk mitigation, and global pharmacovigilance obligations.
• Represent Pharmacovigilance in health authority interactions, audits, inspections, and interactions with external partners as appropriate.

PV Operational Oversight

• Work across Zevra's broader pharmacovigilance operating model, partnering with and providing appropriate medical and strategic oversight to consultants, vendors, and external partners supporting PV science and operations.
• Maintain visibility across core PV activities and external resources, helping ensure appropriate coordination, quality, compliance, and escalation of safety issues across the function.
• Help identify opportunities to evolve PV processes, capabilities, and infrastructure as the organization and portfolio grow.

QUALIFICATIONS:

• MD or equivalent medical degree required.
• 8+ years of progressive pharmacovigilance/drug safety experience within the biopharmaceutical industry.
• Demonstrated experience as a Global Safety Lead, Product Safety Lead, or comparable safety leader, with responsibility for product-level safety strategy and benefit-risk assessment.
• Meaningful post-marketing/commercial pharmacovigilance experience required, in addition to clinical development safety experience.
• Strong experience in signal management, benefit-risk assessment, safety surveillance, and safety governance.
• Strong knowledge of global pharmacovigilance requirements, with experience contributing to key regulatory safety deliverables and health authority interactions.
• Demonstrated ability to represent Pharmacovigilance effectively with senior leadership, cross-functional teams, health authorities, and external partners, including communicating complex safety issues and recommendations to diverse stakeholders.
• Strong medical and scientific judgment, communication, and cross-functional leadership skills, with the ability to operate both strategically and hands-on within a lean organization.
• Ability to take a broad, integrated view of pharmacovigilance, working effectively across PV science, operations, regulatory requirements, and external resources to support an effective safety function.
• Experience in a small biotechnology company and/or an outsourced pharmacovigilance operating model preferred.

Equal Employment Opportunity Statement
Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Notice to External Recruiters
Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.