Associate Director, Clinical Development

Zogenix   •  

Emeryville, CA

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 25 days ago

Associate Director, Clinical Development

The Associate Director Clinical Development will play a key role in the design and execution of ongoing and new development clinical studies. He/she will successfully lead and/or serve as the clinical representative on one or more clinical development teams (US and/or EU-based) to deliver high quality data for registration. The position requires the ability to partner with Regulatory, Early Development, Medical Affairs, Commercial and other stakeholders to deliver clinical programs for registration and launch. The successful candidate will have direct and recent experience in late phase clinical development, and in CRO and KOL interactions.

Responsibilities

  • Serves as a team leader and/or as the clinical representative to a global development team.
  • Works cooperatively with project team members to provide clinical development expertise and leadership.
  • Providing therapy area medical and scientific expertise to Clinical Development and other stakeholders to understand emerging medical discoveries and trends.
  • Writing and Editing of clinical study protocols, clinical study reports, manuscripts, and other study-related documents.
  • In partnership with Regulatory Affairs and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing
  • Work with partners to assure that the strategic positioning is in line with company goals and regulatory requirements
  • Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and integrate factors into planning
  • Prepare abstracts, manuscripts and presentations for external meetings
  • Create an atmosphere of innovation and continual improvement
  • Any additional responsibilities assigned by the leadership.

Qualifications

  • PhD, PharmD, PsyD Doctoral level degree
  • 4-5+ years of clinical development experience
  • Experience in CNS development (Psychiatry or neurology)
  • Possess extensive knowledge of the late stage clinical development process
  • Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business
  • Experience in small molecule development and registration
  • Experienced in presentations (internal and external) and regulatory writing (IND, CTD sections)
  • Proven track record of successful leadership of clinical development project teams
  • Experience building strong relationships within the group (Regulatory, Product Development) and across functional groups (Medical Affairs, Commercial) to achieve results

Other Skills

  • Excellent writing and communication skills
  • Ability to handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies
  • Proven track record of garnering support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change

Special Working Conditions

  • Ability to travel as required, including international travel. Average 10-20%, reaching 50% or more in some months.