Executive Director, Clinical Science
Reporting to the SVP, Clinical Development, the Executive Director, Clinical Science (EDCS) will lead the clinical aspects of the Clovis FAP-2286 development program. FAP-2286 is a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). This individual is responsible for directing the planning and execution of clinical studies in order to successfully move the FAP-2286 program from the IND stage through to later stage trials, and if successful, commercialization, with the expectation that the clinical development program progress in a timely manner, in adherence with GCP, appropriate SOP’s and government regulations.
The ECDS will work closely with individuals in other functional areas (e.g., clinical operations, regulatory affairs, translational medicine/companion diagnostics, pharmacovigilance, project leadership, quality, manufacturing, finance, vendors etc.) in the creation, management, and execution of the FAP-2286 Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and ensuring the successful execution and completion of clinical trials.
The ECDS will also assist with other broad or diverse activities as needed, including Clinical Development activities (e.g., contributing to the development of departmental policies, SOPs, etc), Business Development activities (e.g., contributing to diligence activities for other radiopharmaceutical agents, etc.), and other activities (e.g, competitive intelligence).
- Design, oversee, and execute clinical deliverables in support of the FAP-2286 CDP. Will be responsible for multiple studies as the program expands and moves into later-phase trials.
- Represent Clinical Development on the cross-functional FAP-2286 Project Team that reports into the Executive Committee.
- Lead the cross-functional FAP-2286 Clinical Development subteam in partnership with other Clinical Development and Clinical Operations personnel.
- Attend and contribute, as needed, at meetings with Health Authorities (HAs) related to FAP-2286 program; develop responses to HAs and IRBs on clinical/medical questions.
- Develop and optimize an effective KOL and investigator network to support the FAP-2286 CDP. Convene Advisory Board, Steering Committee and other similar type meetings as needed to support the program. Consult with KOLS for advice on complex development or safety issues; Maintain and lead external collaborations.
- Key clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review process, and other deliverables as needed.
- Assess, recommend, and track functional area budgetary needs for medical/clinical aspects of FAP-2286 program, as aligned with the Clovis operating model.
- Manage other clinical scientists, if appropriate, based on the current / future organizational structure and roles / responsibilities of others in the department.
- Working with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are appropriate for a matrixed environment.
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines.
- A thorough understanding of the phases of clinical development and extensive experience with oncology clinical trials.
- Familiarity with the drug approval process through NDA (or BLA); Familiarity with drug approval process in Europe and/or Japan also preferred.
- Sufficient content expertise to be able to meaningfully contribute to document development (such as INDs, Protocols, IBs, Regulatory Packages, etc.).
- Strong understanding of statistics and study design principles applicable to primary efficacy endpoints in registrational trials to critically assess study conclusions.
- Proven track record of successfully delivering projects on time, to budget and required quality.
- Excellent interpersonal, verbal and written communication skills (including experience in making presentations).
- Ability to build and maintain effective internal and external professional relationships.
- Strong leadership and interpersonal skills.
- Ability to move in a fast paced and dynamic environment.
- Previous management experience required.
Education and Experience
- Advanced degree (e.g., MA/MS, PhD, PharmD, RN, MD) in a field related to biological sciences or a medically related discipline required.
- 10+ years of clinical trial experience, inclusive of at least 4 years of industry experience.
- Prior experience in radiopharmaceutical development and/or nuclear medicine in academic or industry setting required / strongly preferred.
- Strong knowledge of Clinical Development, Site Monitoring, Contract Management, Project and functional outsourcing management.
- Leadership/management experience.
- Office-based position. Occasional travel to clinical sites, investigator meetings, scientific / clinical meetings, etc. as needed.