Senior Director, Clinical Operations/Development

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

Reporting to the Chief Medical Officer, the Senior Director of Clinical Operations / Development will be responsible for management and oversight of the day-to-day operations of clinical trials and studies. This position will ensure all work is conducted in accordance with SOPs, policies, good clinical practices, and applicable regulatory requirements. This position will be responsible for ensuring clinical trials and studies meet quality and timeline metrics. This position requires familiarity and understanding of drug product and clinical trial life cycle. This position also requires knowledge in biological sciences, strong organizational, management, interpersonal skills, and familiarity with a variety of the field’s concepts, practices, and procedures.

The position is based on-site in Boston, MA.

What you'll do

• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
• Selection and management of Clinical Research Organizations for conducting clinical trials including the management of relevant communications and creating/reviewing the appropriate documents such requests for proposals, statement of work, budgets, timelines, operational manuals, CRFs, ICFs, operations and other documentation required for conduct of clinical trials.
• Lead manager of protocols prepares/reviews protocols and amendments.
• Maintains and manages internal clinical trial files and documents.
• Maintains accurate and timely sponsor/site correspondence and communication.
• Reviews data, prepares, and presents clinical data reviews and data summaries.
• Prepare or review required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols.
• Serve as clinical monitor or co-monitor; supervise clinical monitoring activities and resources at CRO sites.
• Manages the day-to-day clinical operations, including management of vendors (e.g., CROs, bioanalytical labs) and coordination of activities.
• Participate in relevant meetings and conference calls with follow up, including CRO meetings such as regular team meetings, SIVs, investigator meetings, etc.
• Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements.
• Travel to clinical research clinics when necessary.
• Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects.
• Other duties as assigned.

Qualifications

• Minimum of 10 years’ experience in the pharmaceutical industry, with a minimum of 7 years direct experience in planning and managing clinical trials.
• Solid understanding of pharmaceutical clinical development processes and experience with clinical monitoring.
• Significant experience with responsible roles in the conduct or management of Phase 1through 3 clinical trials, including first-in-man pharmacokinetic/safety trials in healthy volunteers, bioequivalence, and food effect trials. Experience with CNS and Rare disease therapeutic areas is required.
• BA/BS degree or equivalent; health science degree or