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Vice President, Clinical Development

Reference Number: 3818
Location: MA

Our client is a clinical-stage immuno-oncology company.  They have asked us to assist them in their search for a Vice President, Clinical Development. 

Major tasks and responsibilities will include:

  • Ensures efficient, high quality therapeutic development programs by guiding direction of the clinical development strategy and processes for specified projects within the company.
  • Has accountability and ownership of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, clinical sections of regulatory submissions.
  • Acts as the line manager for a small team of medical directors and clinical scientists and clinical operations.
  • Medically monitors clinical research studies.
  • Determines the direction of peer-reviewed abstracts, manuscript preparation, and presentations.
  • Initiates and develops strong scientific and medical relationships with consultants with particular focus on relationship building and understanding unmet medical needs.
  • Interprets clinical safety, immunogenicity, and efficacy results for strategic regulatory and pharmacovigilance purposes.
  • Provides medical and scientific input to support strategic positioning of the company's pipeline.
  • Provides medical and technical perspective to the Business Development function in the identification of potential partners.
  • Attracts, assesses, retains, and develops highly competent and experienced clinical personnel.
  • Sets clear, focused, challenging targets that allow highly skilled clinical professionals to accomplish significant business objectives consistent with departmental goals.
  • Shares medical expertise with counterparts in other functional areas such as Manufacturing, Quality, Regulatory Affairs, R&D, Legal and BD.
  • Maintains knowledge of and complies with Good Clinical Practice (GCP) specifications as practiced in different geographies.
  • Presents frequently to Executive Leadership team at BOD.
  • Creates and communicates a compelling vision that generates excitement, credibility, and support of the clinical research mission both internally and externally. 

We seek candidates with the following qualifications:

  • Must have an MD, MD/PhD, or equivalent.
  • Specialty oncology training required.
  • Significant experience in the pharmaceutical/biotechnology and/or academic/clinical practice sector required.
  • Requires experience record communicating with regulatory bodies.
  • Must have demonstrated knowledge of GCP rules and regulations, and solid understanding of drug development strategy and process.

If interested, please email your resume as a Word attachment to us, reference 3818.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.