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Vice President, Clinical Development

Reference Number: 4235
Location: MA

Our client is a biotechnology company developing novel therapeutics to treat rare, immune-mediated diseases. They have asked us to assist them in their search for a Vice President, Clinical Development.

Major tasks and responsibilities will include:

  • Develops and manages product profiles and Clinical Development Plans.
  • Communicates regularly and effectively with senior leaders across the R&D organization.
  • Leads the clinical team to secure global regulatory approvals for pipeline products.
  • Evaluates the balance between outsourcing and in-house approaches for various Clinical Development needs.
  • Leads the design, development and implementation of innovative clinical trials for drug candidates and biosimilars translational through global Phase 3 trials and registration.
  • Leads Clinical Development efforts with approaches to drug development across multiple therapeutic areas and product modalities.
  • Applies state-of-the-art knowledge of disease mechanisms to the selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations in support of innovative clinical study designs for novel products.
  • Maintains the highest quality clinical programs, following GCP and ICH guidelines.
  • Manages timely reporting of safety signal to regulatory authorities and the generation of clinical study reports.
  • Provides strategic consultation and guidance to Research on decisions that have significant clinical components and implications.
  • Maintains accountability for all relevant timelines and deliverables.
  • Collaborates with functional counterparts and colleagues to ensure strategic integration of product development plans across the Development function.
  • Manages the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts).
  • Reviews documents including protocols, IBs, informed consent forms.
  • Influences internal and external audiences in a high impact, highly visible way.

We seek candidates with the following qualifications:

  • Ph.D or MD required.
  • Must have a minimum of 7+ years of pharmaceuticals industry experience.
  • Experience in clinical rare diseases highly preferred.
  • Requires a proven track record of successful drug development.
  • Must have experience with Phase 1 through Phase 3 trials.
  • Excellent communication and leadership skills.
  • Requires significant regulatory experience with INDs, CTAs, End-of-Phase 2 meetings and NDA/BLAs/MAA, both US and ex-US.
  • Experience having managed significant accelerations and challenges in clinical programs required.
  • Must be comfortable working with Senior Executive Team, Board members, KOLs, regulatory bodies, and investors.
  • Requires experience working with biotech/pharma partner(s) and preferably prior membership of steering committees.

If interested, please email your resume as a Word attachment to us, reference 4235.  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.