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Director/Senior Director, Clinical Development

Reference Number: 3906
Location: MA

Our client is a clinical stage biotechnology company. They have asked us to assist them in their search for a Director/Senior Director, Clinical Development.

Major tasks and responsibilities will include:

  • Provides leadership, strategy, direction and coordination with key research functions to one or more drug development programs.
  • Collaborates with the Clinical Operations lead to coordinate study activities in the program.
  • Leads the development and execution of the Clinical Strategy/Clinical Development Plan.
  • Provides medical oversight into protocol development, study conduct, data generation, and reporting.
  • Oversees Phase I-III clinical development programs to support the Company’s strategy.
  • Ensures regulatory requirements and quality standards are met and compliance obligations for Good Clinical Practices guidelines and standard company operating procedures are maintained or exceeded.
  • Acts as Company representative interacting with external scientific thought leaders and regulatory authorities for assigned program(s).
  • Searches and analyzes medical literature.
  • Writes/reviews abstracts, manuscripts, etc., for publications and/or presentation at internal and/or external meetings.
  • Leads and participates in investigator meetings and advisory committee meetings as needed.
  • Leads and participates in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program. 
  • Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
  • Co-leads product safety review committees as appropriate.
  • Provides consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials.
  • Participates in due diligence efforts for clinical partnerships and/or in-licensing opportunities.
  • Works with specific clinical and research partners to facilitate seamless execution of collaborative efforts.
  • May act as deputy for Head of Clinical Development.
  • May supervise other Medical Directors and/or Clinical Scientists.

We seek candidates with the following qualifications: 

  • Requires an advanced degree (MD or equivalent).
  • Board-certification in medical oncology/hematology highly preferred.
  • Subspecialty training in a discipline relevant for oncology/hematology therapeutic area required.
  • Must have experience in regulatory interactions throughout the different phases of development.
  • Requires the demonstrated potential or ability to design, initiate, and conduct clinical studies.
  • Experience and solid understanding of drug developing strategy and process required.
  • Proven experience as a study director in academia or industry, experience in phase I/II oncology clinical trials required, phase III experience preferred.
  • Must have the proven ability to analyze and interpret efficacy and safety data relating to oncology.
  • Requires Strong interpersonal skills, the ability to influence, and the ability to function in a global team environment.
  • Strong and effective communication skills (written and verbal), with excellent medical/scientific writing skills required.
  • Must have demonstrated leadership experience leading the successful development of drug therapies on time, on budget and with quality assurance and regulatory compliance.
  • Excellent personal ethical integrity and a commitment to improving the outcomes for patients.

If interested, please email your resume as a Word attachment to us, reference 3906.  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.