Mar 14, 2019

Senior Medical Director, Clinical Development

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

Job Description

The Role

Reporting to the Vice President, Clinical Development, the Senior Medical Director, Clinical Development provides medical monitoring for one or more gene therapy programs. The Medical Director leads design, implementation, monitoring, analysis, and reporting of clinical studies conducted within one or more programs. In addition, collaboration with other team members and functions to develop long-range strategic plans for the programs and execute upon these plans. The current focus of drug development at Audentes is in the development and commercialization of highly innovative gene therapy technology in diseases where there is unmet medical need and for children and adults with serious, rare genetic diseases. Importantly, the needs of the patient and family are uppermost in our minds as we progress our programs, and this philosophy is one that needs to be embodied in all colleagues at Audentes and in particular by the physicians.

Specific responsibilities include but are not limited to:

  • Participate in activities related to phase 1-4 clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports and review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).Partner with Research, Regulatory Affairs, Non-Clinical Science, and Medical Affairs to ensure timely and effective clinical and scientific input into overall program. Participate in investigator meetings and lead site initiation visits with clinical trial investigators, and partner with Clinical Operations and Medical Affairs in driving enrollment into the clinical studies Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities, as directed by the CMO and VP, Clinical development
  • Study Data Review and Analysis
    • Provide clinical input into statistical planning and lead data analysis and interpretation
    • Perform ongoing review and analysis of study data
    • Provide medical leadership as needed for scientific issues that may arise during clinical trial execution
    • Provide medical leadership and support for publication of data (manuscripts, posters, etc.) and disease or technology related scientific publications
  • Lead efforts to develop strategic partnerships with Key Opinion Leaders
  • Define, plan and provide Medical Monitoring to clinical development studies
  • Review adverse events, monitor safety and prepare analysis and regulatory submission.
  • Conduct thorough medical review of individual case safety reports (ICSRs)

Required Education, Skills and Experience

  • Medical Degree; board certification in a relevant specialty such as Pediatrics, Internal Medicine, Metabolic Diseases, Genetics or Neurology
  • 5-8+ years biotechnology/pharmaceutical relevant experience leading clinical drug development (early stage development through approval,) including developing clinical protocols, study design and successful regulatory approval (INDs, BLAs, NDAs) with US and international regulatory agencies
  • Proven clinical development experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
  • Proficient in the use of industry-standard software (eg. Microsoft Office Suite, WebEx, electronic data capture systems [RAVE, InForm, etc].
  • Proficient in data analysis software (Excel, SigmaPlot, 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, Preclinical Science and Product Development
  • Demonstrated success working with and influencing key external stakeholders (KOLs, investigators, researchers) including presenting/responding to the FDA and other regulatory authorities
  • Understanding of global pharmacovigilance regulatory requirements and guidance documents and proven ability to influence decision making around multifaceted issues involving medical safety
  • Outstanding leadership skills, comfortable, and indeed thrive in a flexible, dynamically changing and challenging environment
  • Excellent strategic planning, organizational and communication skills
  • Highest level of scientific integrity
  • Expertise and consistent success in scientific research and/or clinical practice (as evidenced by appropriate higher qualifications, publication and/or relevant specialist accreditation)
  • Willingness to travel ~30-40%, with international travel at times

Preferred Education, Skills and Experience

  • PhD degree
  • Prior management experience, successfully managing other development/clinical research professionals
  • Rare disease experience
  • Gene therapy experience

Job Details

Reference # R-201811KW
Posted on 30 Nov 2018
Closes on  
Location(s) San Francisco
Department Clinical Development
Career level Management
Hours/Status Full-time

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