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.
Job Summary
The Director of Clinical Development is responsible for leading and managing clinical development programs, ensuring the successful design and execution of clinical trials, and overseeing regulatory compliance. This role collaborates with cross-functional teams, including medical affairs, regulatory affairs, and clinical operations, to drive the development of innovative therapies from early-stage research through late-stage clinical development.
Key Responsibilities
- Develop and oversee clinical development strategies for assigned programs.
- Lead the design, execution, and monitoring of clinical trials to support regulatory submissions and product approvals.
- Ensure adherence to Good Clinical Practice (GCP) and other regulatory requirements.
- Collaborate with regulatory agencies to facilitate approvals and address inquiries.
- Work closely with cross-functional teams, including R&D, medical affairs, and commercial teams, to align clinical programs with business objectives.
- Provide medical and scientific expertise for clinical development plans and study protocols.
- Oversee data analysis and interpretation, ensuring accurate and timely reporting of clinical trial results.
- Manage clinical budgets, timelines, and resources efficiently.
- Identify and establish relationships with key opinion leaders, investigators, and research institutions.
- Stay up to date with industry trends, emerging therapies, and regulatory changes.
Qualifications & Experience
- Advanced degree in Medicine (MD), Pharmacy (PharmD), or Life Sciences (PhD, MS) preferred.
- Minimum of 8-10 years of experience in clinical development within the pharmaceutical, biotechnology, or medical device industry. Docusign Envelope ID: 9D0539DB-1EB7-4E78-9051-73FA84CF0073
- Strong knowledge of clinical trial design, execution, and regulatory requirements (FDA, EMA, ICH-GCP).
- Experience in leading cross-functional teams and managing multiple clinical programs.
- Excellent leadership, communication, and problem-solving skills.
- Proven ability to analyze complex data and provide strategic insights.
- Experience in working with regulatory agencies and submitting regulatory documents.
- Ability to travel as required for meetings, conferences, and site visits.
Preferred Qualifications
- Experience in an orphan disease clinical trials preferred.
- Prior experience in both early and late-stage clinical development.
- Prior experience in managing decentralized clinical trials
- Strong publication record and experience presenting at scientific conferences.
This role offers a dynamic opportunity for a seasoned clinical development professional to contribute to groundbreaking advancements in medical science and patient care.
