SVP/Head, Clinical Development

Massachusetts
4469
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a SVP/Head, Clinical Development.  

Major tasks and responsibilities will include:
  • Leads clinical development physician team.
  • Prioritizes efforts and delivers on corporate goals and objectives.
  • Plays a key supporting role in all business development discussions (in-licensing and out-licensing) across the portfolio.
  • Plays a key role in the design and implementation of the clinical development strategy across the entire portfolio.
  • Leads creation and implementation of innovative trial designs to accelerate delivery of high quality data to address key scientific questions, including proof-of-concept.
  • Serves as the medical lead for clinical stage programs. Oversees all medical aspects of the conduct of clinical studies (e.g. safety/benefit risk determination, protocol deviation review, clinical quality, etc.), partnering closely with cross functional Heads.
  • Provides medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serves as primary point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
  • Represents the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
  • Leads authorship of clinical sections of regulatory submissions and represents the company at regulatory meetings.
  • Actively participates with the corporate leadership team on the strategic direction of business and provides guidance on opportunities/hurdles.
  • Develops and manages budgets required to implement clinical development plans, and regularly reports plan progress to stakeholders.
  • Leads and conducts the performance management throughout the year for the clinical development physician team; this includes assuring clinical development employees are properly managed, qualified, and trained to perform their jobs effectively.
  • Coaches, manages, and mentors direct reports while providing job enrichment and developmental opportunities.
   
We seek candidates with the following qualifications:
  • MD, DO, or foreign equivalent is required.
  • Must have prior management experience with a focus on attracting and developing high performing physician talent.
  • Deep experience as a drug developer with established track record of success across all phases of development is required.
  • Requires hands on experience working in a translational medicine/early development capacity.
  • Prior achievement in basic research is preferred.
  • Prior experience thriving in a small/entrepreneurial setting is preferred.
  • Must be a team player with strong negotiation, problem-solving, and strategic influencing skills.
  • Hands on experience negotiating with regulatory authorities is required.
  • Requires highly developed written and verbal communication skills, including the ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
  • Must have the proven ability to perform successfully under stringent timelines and with changing and competing priorities.
 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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