Director, Clinical Science

San Francisco, CA | Clinical Development

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Job Description

Job Summary

Reporting to the VP, Clinical Development, the Director, Clinical Science (DCS) will be a key contributor to Clovis’ clinical development programs.  In conjunction with others in Clinical Development, this individual is responsible for directing the planning and execution of clinical studies in order to successfully move programs through the clinical research process in a timely manner, in adherence with GCP, appropriate SOPs, and government regulations.

 

The DCS will work closely with individuals in other functional areas (e.g., clinical operations, regulatory, pharmacovigilance, pharmacology, translational medicine, companion diagnostics, project management, quality, manufacturing, etc.) in the creation, management, and execution of one or more clinical trials/programs, in developing innovative and efficient solutions to medical and scientific clinical trial issues, and ensuring the successful execution and completion of Clovis’ clinical trials.  The DCS may also assist with other broad or diverse activities as needed, and when appropriate

 

Job Responsibilities

  • Under the direction and oversight of the VP, Clinical Development, design, oversee and/or execute, as needed and as appropriate, clinical deliverables in support of the clinical program objectives as defined and approved.
  • Key clinical deliverables include document development (Study Concepts/Synopses, Protocols, ICFs, etc.), contribution to clinical sections of other key documents (Investigator Brochures, INDs, NDAs, Briefing Documents, abstracts, manuscripts, etc), and medical and scientific input into the development of deliverables required for study activation, conduct, and closure (CRFs, SAP, Data Listings, CSRs, etc.)
  • Review, analyze, interpret and present clinical data both internally and externally.
  • Represent a clinical study or development program on one or more teams or subteams
  • Contribute to and optimize an effective KOL and investigator communication strategy.  Interact with investigators as warranted to obtain necessary information before, during and after the study.  Organize and present at KOL advisory board and investigator meetings.
  • Train/mentor Clovis colleagues, CRO and study site staff on the therapeutic area, molecule and clinical documents as appropriate.
  • 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.

Skills & Requirements

Qualifications

  • Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
  • Extensive clinical oncology experience; candidates with exceptional experience in other therapeutic area(s) would be considered if they demonstrated clear potential to apply their existing skills to oncology.
  • A thorough understanding of the phases of clinical development.  Familiarity with the drug approval process through NDA (or BLA) in US is required.  Familiarity with ex-US drug approval process also preferred.
  • Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the VP, Clinical Development.
  • Proven track record of successfully delivering projects on time, to budget, and with the 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.
  • Leadership and interpersonal skills are a necessity.  Must be able to facilitate and work in a team environment.
  • Ability to move in a fast paced and dynamic environment.
  • Proficient in Microsoft Word, Excel and PowerPoint and extensive experience with clinical trial databases (eg. Medidata Rave, InForm, etc.)

Education and Experience

  • Clinically related science degree (PhD, RPh, BSN-NP, PharmD, MPH, PA, MA/MS) preferred; other advanced degrees and/or relevant experience will also be considered.
  • 10+ years clinical trial experience, including at least 7 years of industry experience.

Working Conditions

  • Office-based position.  Able to travel to clinical sites, investigator and advisory board meetings, medical/scientific conferences, etc., as needed.