Senior Director, Autoimmune Clinical Biomarkers

Highly Competitive Salary
  1. Permanent
  2. Project/Study Manager (CSM/CPM), Program Manager / Director, Clinical Scientist
  3. United States
Cambridge, USA
Posting date: 13 May 2021

We are seeking a Clinical Biomarker Senior Director to develop and drive biomarker strategy across autoimmune / immune inflammation clinical compounds working collaboratively with cross functional therapeutic team members. The role will lead a team of direct and indirect reports to liaise with external assay laboratories, collaboration partners and CROs.

Job Responsibilities:

  • Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of autoimmune / immune inflammation compounds
  • Develop the biomarker strategy with input from the research and clinical leads for the study
  • Drive the biomarker strategy to ensure assay labs complete appropriate qualification or validation work in order to execute on the clinical biomarker plan on time and with good quality
  • Ensures the timely and efficient delivery of all biomarker operational aspects across therapeutic area clinical trials
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition
  • Responsible for collaborating closely with Translational Science/Research and Biosample leads to execute biomarker operational strategies, serving as a single point of contact for biomarker operations across teams, and with collaborators, assay labs and CROs.
  • Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads
  • Ensure collection, delivery and analysis of biosamples according to the protocol and in compliance with protocol, informed consent, local regulations as well as GCP/ICH
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
  • Leads the development and finalization of the Biomarker Plan based on input from scientific and operational team members to deliver on biomarker operational strategies
  • Develops and provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
  • Attends operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data reporting

Skills and Requirements:

  • MS (with at least 8 years pharmaceutical/biotechnology experience) or Ph.D. (with at least 5 years of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, molecular biology, biotechnology).
  • Experience in clinical translational or biomarker work and its role across autoimmune / immune inflammation drug development from early phase through licensure
  • Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation and implementation.
  • Experience in managing third party assay laboratories, collaborations and budget management.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.