Senior Director, Autoimmune Clinical Biomarkers
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.
- 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 firstname.lastname@example.org.
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