Sanofi Group Clinical Research Director - Oncology in Cambridge, Massachusetts
Clinical Research Director
Leads clinical trial strategy of assigned programs within clinical development teams for one or more multiple myeloma assets, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan.
Job duties and responsibilities:
Establishes or adapts clinical development plans for the programs including discussions with clinical investigators, advisors and regulatory authorities and contingency planning.
Authors protocol extended synopses, clinical sections Investigator Brochure, clinical sections of IND/IMPD fillings, annual reports, development risk management plans. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries, including regulatory submissions.
Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial program within a matrix environment
Presents and discusses development strategy and clinical study results with key internal stakeholders, external investigators and advisory boards, and regulatory authorities, as appropriate
Author clinical abstracts, presentations for conferences, and manuscripts, when appropriate
MD degree or equivalent Oncology and/or Hematology fellowship or significant experience (5+ years) in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies.
Expertise in medicine, oncology and pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), preferably with experience in early development.
Demonstrated ability to interact productively with and attract top external investigators.
Demonstrated ability to work with a multi-functional team to achieve project milestones.
Understanding of and willingness to meet applicable regulatory, quality and compliance standards.
Preferred location is Cambridge, MA. Will also consider candidates in Bridgewater, NJ and Vitry, France
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.