Sanofi Group Translational Medicine Lead Oncology in Cambridge, Massachusetts
Sanofi is expanding its pipeline and capabilities in oncology and is seeking outstanding Director Clinical Precision Medicine lead with significant experience in 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 (mainly US)
Working with early- and/or late-stage clinical development teams, the candidate will have the opportunity to elaborate clinical biomarker plans for oncology programs from the pre-candidate selection up to submission stage.
Responsible for delivering high quality biomarker strategies for patient selection, target engagement and pharmacodynamics endpoints.
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 operations, assay development labs, biostatistics, bio-informatics experts, PK and clinical team.
Lead the translational medicine sub team with representatives from these functions, coordinating efforts for data generation, interpretation and manage communication flow related to key biomarker program information, risks and milestones across key stakeholders including therapeutic area leadership, functional leads and team members.
Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals and consent forms.
Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
Point contact for resolving study biomarker issues.
Interface with discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.
As appropriate, provide biomarker expertise to progress validated biomarkers into development of pharmaco-diagnostic tools.
Proactively identify and engage external KOL’s on specific hypothesis-driven collaborations to complement internal effort and drive the publication of biomarker and translational research for respective studies.
The candidate may be involved in the evaluation of external assets and represent Sanofi translational medicine in key partnerships.
PhD or MD required.
Fluent English mandatory.
8+ years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials in Oncology.
Deep knowledge of cancer biology, biomarker strategies and application to clinical trials.
Experience in high-impact contributions to biomarker discovery and/or assay development.
Experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team.
Experience in managing research collaborations, contract laboratories and budgets.
Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
Effective verbal and written communication skills.
Flexibility to work on multiple projects as the portfolio evolves over time.
Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms.
Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
Strong interpersonal skills and ability to thrive in a matrix environment.
Knowledge in companion diagnostic.
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.