Senior Director, Autoimmune Clinical Biomarkers job in Cambridge, USA

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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?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM), Program Manager / Director, Clinical Scientist

Location: United States

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

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 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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