Senior Director Clinical Development

Aliso Viejo, CA 92656

Posted: 06/07/2019 Employment Type: Direct Hire Industry: Clinical Job Number: 6342

Reporting to the Vice President of Clinical Development, the Senior Director Clinical Development is responsible for the design, planning, and medical oversight of clinical studies for all phases of development. The Senior Director, Clinical Development will collaborate with Clinical Operations for study implementation and serve as medical monitor. The Senior Director, Clinical Development will also oversee interpretation and dissemination of study results, including clinical study reports and related publications.  The Senior Director of serve as a core member of the clinical development team, will contribute to devising of the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations. 

Essential Job Functions

Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance.  Develop and implement SOPs for clinical trials and related activities, as required.  Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.

 
  • MD degree with a valid medical license required. Clinical experience in Neurology or Psychiatry required.
  • 10 years of experience in the biotechnology / pharmaceutical industry with at least five years of hands-on clinical trials management and/or clinical development teams. Experience in CNS drug development highly preferred.
  • 10+ years of experience leading, developing, mentoring and manage others required
  • Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems
  • Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design
  • Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
  • Strong knowledge of FDA and ICH regulations
  • Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
  • Expert knowledge of Good Clinical Practice (GCP)
  • Ability to multi-task and manage several projects in parallel, paying attention to detail
  • Ability to forge cross-functional working relationships with internal teams and external project partners
  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion
  • Ability to travel up to 25% of time
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