Sr. Director, Clinical Assay Lab Head job in Cambridge, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Research Associate (CRA), CRA Manager, Project/Study Manager (CSM/CPM)

Location: United States

This vacancy has now expired. Please see similar roles below...

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 m.robinson@proclinical.com.

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.

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