Director, Rare Disease Clinical Biomarkers

Highly Competitive Salary
  1. Permanent
  2. Project/Study Manager (CSM/CPM), Program Manager / Director, VP/Head of Clinical Operations
  3. United States
Cambridge, USA
Posting date: 18 May 2021

Proclinical is seeking a Clinical Biomarker Director to develop and drive biomarker strategy across Rare Disease 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:

  • Lead a team of dedicated Clinical Biomarker leaders with responsibility for all clinical biomarkers within the Rare Disease pipeline
  • Collaborate with clinical and research teams to define overall biomarker strategies for upcoming Rare Disease programs
  • Oversee biomarker plans and strategy with input from research and clinical leads for Rare disease studies
  • Responsible to ensure assay labs complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality for Rare disease clinical biomarker assays
  • Ensure timely and efficient delivery of all biomarker operational aspects across Rare disease clinical trials: accountable for planning, coordinating, and overseeing all operational activities by the Rare disease clinical biomarker team as required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition with support from the Biomarker Operations
  • Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICH
  • Serve as a primary point of contact for biomarker operations across Rare disease with collaborators, assay labs and CROs.
  • Contribute to the identification and selection of biomarker vendors and aid in building the strategy for the selection of those vendors
  • Represent Rare disease teams on governance bodies, contribute to protocol writing, INDs and BLAs as well as attend CRO kick-off meetings to lead biomarker activities across the Rare disease and Autoimmune space
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection

Skills and Requirements

  • PhD (with at least 5 years pharmaceutical/biotechnology experience) in the Rare disease space
  • Experience leading a team of clinical translational or biomarker scientists and deep understanding of the role of clinical biomarkers across drug development from early phase through licensure
  • Understanding of the CDx and Complimentary diagnostics space and requirements
  • Deep understanding of the regulatory expectations for pivotal biomarkers in clinical trials
  • Solid experience in the application of biomarkers during development of assets required including experience with clinical translational research, development, validation and implementation of biomarkers in the Rare Disease space.
  • Experience in managing third party assay laboratories, collaborations and budget management.
  • Strong communication and project management skills

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.