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Vice President Clinical Development

Reference Number: 3366
Location: MA

Our client is a global biotechnology company.  They have asked us to assist them in their search for a Vice President of Clinical Development

Major tasks and responsibilities will include:

  • Oversees the design, execution and report of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for achieving desired end points and approval of drug candidates.
  • Interacts with global regulatory agencies and responsible for authoring and/or reviewing relevant IND/BLA sections and generating responses.
  • Collaborates with Project Team Leaders, manages a virtual clinical development group comprising a diverse team of consultants including the functions of biostatistics, data management, and medical writing.
  • Ensures adherence to regulatory requirements of study conduct and industry standards in accordance with Good Clinical Practice.
  • Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Interprets results of clinical investigations in preparation for new drug applications to relevant regulatory authorities.
  • Manages the presentation of key clinical findings to internal and external constituents.
  • Develops manuscripts for publication in peer-reviewed journals and prepare presentations for scientific conferences as well as for clinical study investigator meetings and clinical advisory meetings.
  • Establishes productive, interactive relationships with key internal departments, as well as the medical and scientific community.
  • Represents the Company as needed as a clinical spokesperson at a variety of scientific, business and government groups/agencies.
  • Develops and maintains yearly and long-term budget and resource plans for all IND-enabling- and clinical stage programs.
  • Serves as a key member of the Senior Management Group and work across the organization and provide clinical research insights across the multiple program teams.
We seek candidates with the following qualifications:
  • An MD with Board Certification in Oncology or Hematology is required, preferably with experience in immunology.
  • Must have 10+ years of experience in clinical development obtained in the biopharmaceutical industry.
  • Must have excellent knowledge of the drug development process, preferably with significant experience with biologics.
  • Hands-on experience of designing and conducting clinical trials in oncology and immune-oncology related therapeutic areas is required.
  • Must have experience of working in a leadership role within a clinical development project team, including a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
  • Must have strong communication skills (including writing and presentation skills) with success in influencing at all levels and the ability to work effectively in a trans-Atlantic team.
  • Proven leadership abilities in a highly complex, fast-paced and resource-lean environment where an ambidextrous skill set is essential for success.

 

If you are interested, please email your resume as a Word attachment to us, reference 3366.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.