Mar 14, 2019

Director, Clinical Science

  • Audentes Therapeutics
  • San Francisco, CA, USA
Full time Pharmaceutical Medical Affairs

Job Description

The Role

Reporting to the Vice President, Clinical Development, the Director, Clinical Science will be responsible for providing scientific support for clinical development activities. This role will collaborate closely with Clinical Operations, Research, Bioanalytics, Regulatory Affairs, Non-clinical, Clinical Development, Clinical Operations and Quality Assurance. The Director, Clinical Science will ensure alignment between clinical strategy and clinical study protocols, operational structure, and operating procedures. The candidate will be responsible for ongoing data analysis, summarizing study results for preparation of documents and publications and supporting project teams with scientific information and progress updates related to the assigned clinical studies. Other responsibilities will include leading development of clinical development related documents including study synopses and protocols, investigational brochures, clinical study reports and documents that support development and execution of clinical studies. This position will be based in our San Francisco offices.

Specific responsibilities include but are not limited to:

  • Provide strategic direction and lead staff in design, execution in the Clinical Sciences function
  • Provide scientific input to translational studies, clinical development programs and definition of efficacy and safety endpoints for Phase I, II and III clinical trials.
  • Collaborate with the clinical development team on medical monitoring, and the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting.
  • Prepare data and contribute to scientific publications including posters, abstracts and manuscripts.
  • Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations.
  • Provide input and collaborate across all functional areas, including research, non-clinical, clinical development, clinical operations, project management, biostatics, data management, and regulatory affairs departments.
  • Represent the company at investigators' meetings, as directed by the CMO and VP, Clinical development.
  • Co-author relevant sections of clinical documents and publications pertaining to translational biomarkers (e.g. Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures, abstracts and manuscripts) and documentation for submission to regulatory agencies.

Required Education, Skills and Experience

  • PhD/MS degree in a relevant scientific area with 12+ years of experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
  • Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
  • Direct experience coordinating trial activities, in clinical sample management and biomarker analysis.
  • Proven scientific leadership when working with collaborative, multi-functional teams. 
  • Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders. 
  • Demonstrated experience authoring submissions documents to regulatory agencies. 
  • Proficient in data analysis software (Excel, SigmaPlot, GraphPad, SPSS, R, etc) and data presentation.
  • A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Non-clinical Science and Product Development.
  • Highest level of scientific integrity.
  • Commitment to Audentes values: Be BOLD, Care deeply, #GSD

Preferred, Skills and Experience

  • Experience with project management software (e.g. MS Project, Spotfire, Smartsheets, JIRA, etc.)
  • 3+ years' experience in a Senior Leader role

Job Details

Reference # 2019B-212
Posted on 24 Feb 2019
Closes on  
Location(s) San Francisco
Department Clinical Development
Career level Management
Hours/Status Full-time
More details (document)

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