Sr. Director, Clinical Assay Lab Head

Highly Competitive Salary
  1. Permanent
  2. Clinical Research Associate (CRA), CRA Manager, Project/Study Manager (CSM/CPM)
  3. United States
Cambridge, USA
Posting date: 19 May 2021

Proclinical is seeking a Senior Director, Clinical Assay Lab Head to lead a regulated clinical biomarkers laboratory group with responsibilities for developing, validating and running pivotal clinical biomarker assays across multiple therapeutic areas. The Senior Director will help with the design and implementation of a new clinical biomarker laboratory, as well as staffing and bioanalytical platform selection.

Job Responsibilities:

  • Lead a team of dedicated and senior laboratory scientists to develop and validate new clinical biomarker assays under appropriate guidance/regulations for clinical trial use
  • Oversee the establishment of a new bioanalytical laboratory for clinical biomarkers using immuno assays, genetic assays and flow cytometry
  • Build out a new quality and information infrastructure for the Clinical Biomarker laboratory
  • Lead the assessment of new technology and scientific breakthroughs for use inv clinical biomarker assays
  • Lead development of new clinical biomarkers for programs across the pipeline
  • Responsible to ensure assay the Clinical Biomarker lab completes appropriate development, qualification or validation of bioanalytical assays in order to execute the clinical biomarker plan on time and with good quality for Rare disease and Autoimmune clinical biomarker assays
  • Ensure timely and efficient delivery of all biomarker data for clinical programs
  • Oversee a rapidly growing team of senior and junior laboratory scientists
  • 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
  • Contribute to the identification and selection of biomarker vendors and aid in building the strategy for the selection of those vendors
  • 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 6 years pharmaceutical/biotechnology experience) in leading a bioanalytical laboratory, with experience in immunoassays, sequencing and flow cytometry
  • Experience leading a team of laboratory scientists
  • Experience with and deep understanding of relevant GxP and ICH guidance around clinical biomarker quality expectations
  • 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 Oncology 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.