Clinical Biomarker Lead
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Sanofi is expanding its pipeline and capabilities in oncology and is seeking a clinical biomarker lead with experience in immuno-oncology and cancer biology to help further develop safe and effective medicines for cancer patients. The candidate will be based in Cambridge, US and work in a multicultural environment with colleagues at different geographic locations (US, France)
- The candidate will be involved in large clinical programs with multiple studies and will work under the mentorship of global translational medicine lead(s) in charge of the global program(s)
- This role oversees pharmacodynamic, mechanism of action/resistance, patient selection, and other clinically relevant biomarker studies through external CRO and internal efforts.
- He/she undertakes cross-functional engagement with clinical science and clinical operations for implementation of biomarker analyses in the clinic
- He/she will ensure the output of the biomarker plans meets established program standards (within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline progress without compromising quality.
- To achieve these goals, the candidate will partner with internal functions such as biomarker operational management, labs for biomarker assay development and clinical bioanalysis, biostatistics, bio-informatics experts and clinical stakeholders.
- He/she will participate to the clinical biomarker sub team led by the translational medicine lead that includes representatives from these functions.
- He/she will lead drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
- As appropriate, he/she will provide biomarker expertise to progress validated biomarkers into development of pharmaco-diagnostic tools.
- PhD or MD required
- 2+ years in drug development or research
- Fluent English mandatory
- Expertise in oncology, immuno-oncology or immunology preferred
- Deep understanding of the role of translational research/medicine and clinical biomarkers in drug development
- Lab experience in biomarker detection/measurements (e.g. by Elisa, flow-cytometry, IHC, mass spec,…)
- Ability to effectively cooperate and partner with several functions that could be testified by working experience in projects (for instance as global project lead or core team member)
- Knowledge in companion diagnostic
- Communication and analytical skills to regularly interface with a wide variety of stakeholders within and outside the organization
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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