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Director of Translational Medicine

Reference Number: 3004
Location: NJ

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Director of Translational Medicine.

The Director of Translational Medicine supports the development of oncology compounds by supporting the implementation of scientifically-driven clinical development plans, including correlative scientific components in all pivotal studies.

Major tasks and responsibilities will include:

  • Acts as pathway subject matter expert within the clinical development team.
  • Ensures timely execution of patient selection, stratification, pharmacodynamic and correlative studies for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations and Academic Labs) for assigned program(s) with limited oversight.
  • Contributes input to the clinical team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders.
  • Liaises to facilitate companion diagnostic development as needed and serve as a member of the Biomarker/Diagnostics sub-team where implemented.
  • In collaboration with Molecular Diagnostics and Translational Medicine, identifies and validates external laboratories involved in CTAs for clinical trials and companion diagnostic development.
  • Authors the biomarker portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports.
  • Supports regulatory submissions by acting as subject matter expert within the team.
  • Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents.
  • Coordinates data requirements with reference labs to support submission.
  • Partners with Biomarker Trial Heads and other internal stakeholders to ensure all aspects of data collection are executed with high quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples.
  • Actively educates other team members through knowledge sharing.
  • Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamic monitoring and correlative studies.
  • Acts as core member of the International Clinical Team.

We seek candidates with the following qualifications:

  • MD, PhD or MD/PhD with a minimum of 7 years of experience in correlative science in Oncology, including biomarkers, of which a minimum of 3 years must be in the pharmaceutical industry.
  • Must have a minimum of 2 of experience in development and implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience.
  • Residency in a general medical field with additional subspecialty training, preferably in Oncology, Molecular Pathology, or Lab Medicine.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3004. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.