Clinical Biomarker, Senior Director

Proclinical is currently recruiting for a Clinical Biomarker Senior Director with a leading biotechnology company located in Cambridge, MA. Successful candidate will liaise with external assay laboratories, collaboration partners and CROs. This position will work collaboratively across several disease teams and associated compounds to ensure planning, execution and data delivery of the biomarker strategy for clinical trials conducted by the company and will manage a team of direct and indirect reports.

Job Responsivities:

• 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 (8+ years pharmaceutical/biotechnology experience) or PhD (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 drug development from early phase through licensure.
• Companion diagnostic development experience is desirable.
• 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) 929-388-1651 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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