Vice President, Clinical Development

Location
San Diego, CA, United States
Posted
Jan 18, 2019
Ref
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Required Education
Doctorate/PHD/MD
Position Type
Full time
Function/Scope:

The Vice President of Clinical Development will provide strategic direction and technical leadership to the clinical development group and is responsible for the overall management and performance of department functions from Phase I-IV for drug products, including: clinical trial design, implementation and execution, clinical research, data analysis and management. The Vice President of Clinical Development is responsible for overseeing clinical development and pharmacovigilance according to agreed-upon deadlines and budgets. Working closely with the CMO, the Clinical Development/Pharmacovigilance/Biostatistics group(s), R&D, Regulatory, Medical Affairs and the Commercial Development teams, the Vice President of Clinical Development will develop and execute regulatory and Phase I-IV clinical trial strategy and design. The Vice President of Clinical Development is responsible for the management of the Clinical Development department.

Duties and Responsibilities Include But Are Not Limited To:
  • Responsible for preparing clinical portions of new Drug Applications and Biologics License Applications, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
  • Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings.
  • Establish and maintain relationships with alliance partners, external companies (such as CRO), investigators and opinion leaders to optimize performance on clinical trial activities.
  • Prepare manuscripts for technical journals and make presentations at scientific meetings.
  • Work collaboratively with Research and Development providing input into design of preclinical trials to support drug products entering or in the clinic and by helping initiate Investigational New Drug Applications
  • Provides input to evaluate products for in licensing/out licensing.
  • Participate in business development processes as needed.
  • Accountable for clinical portion of regulatory documents such as Investigator Brochure update, and Drug Safety Update Reports.
  • Manage and be responsible for pharmacovigilance for clinical projects including review and reporting of SAEs with support from pharmacovigilance providers as available.
  • Performs other duties as required.
  • Appendix A: Accountable for medical monitor activities for Phase I-IV studies through direct execution of activities or supervision of a medical monitor dependent on current staffing.

Desired Knowledge and Abilities:
  • Exemplify Tocagen's guiding principles of building strong teams, leading with inspiration, making data driven decisions, and maintaining focus,
  • Critical, creative and deep thinker.
  • Demonstrated ability to think strategically and successfully operationalize ideas and visions
  • Excellent communications skills; team member that can work collaboratively and extremely well with colleagues across all functions and levels.
  • High level of personal integrity, high moral character, excellent work ethics and respect for colleagues at all levels, and empathy.
  • Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills.
  • Excellent manager with a desire to help with career development of individuals on cross-functional teams
  • Demonstrated experience of FDA/EMEA/Japan PMDA requirements, good clinical practices and pharmaceutical clinical development in oncology.
  • Demonstrated experience leading to drug approval
  • Must have leadership experience in a high growth environment and the ability to delegate tasks as appropriate.
  • Ability to build on solid relationships with the NCI, NIH and other agencies including European collaborative groups and to forge strong internal and external partnerships.
  • Excellent analytical and strategic planning skills, with a track record of recruiting and/or out-sourcing high-performing clinical teams.
  • Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously.
  • Ability to maintain a problem-solving attitude in response to time demands and unexpected events.
  • Capable of supporting multiple projects simultaneously.
  • Ability to succeed in a deadline-driven environment.
  • Work proactively and effectively in a fast-paced environment.
  • Ability to work accurately with close attention to detail.
  • Ability to adapt to changes in company structure and responsibilities.
  • Ability to travel domestically and internationally

  • Education/Experience:
  • MD required in a relevant scientific discipline.
  • Minimum of approximately 6 years' experience in relevant industry experience in clinical/medical research or pharmaceuticals/devices.
  • Minimum 4 years of supervisory experience managing a clinical functional team.
  • Oncology experience required.