Senior Director, Clinical Operations/Development

Zevra Therapeutics • Boston, MA

224d

About The Position

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.

Requirements

• 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 1 through 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 biologic science degree is preferred.
• Good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.
• Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage timelines and budgets.
• Detail-oriented, a self-starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment wherein all clinical trials are outsourced.
• Proficient with MS Office, and with MS Word (experience with Word formatting features such as Styles).

Responsibilities

• 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.

Benefits

• Travel: Requires travel on a frequent basis to meet with potential partners and internal and external stakeholders, or to attend national and international scientific meetings and congresses.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree