Sanofi Group Clinical Development Lead, Multiple Myeloma - Cambridge, MA in Cambridge, Massachusetts

Clinical Development Lead, Multiple Myeloma (Next Gen CD38 mAb)

Job Summary

Reporting to the Clinical Lead/Project Head for Multiple Myeloma, lead one or more multi-functional development Global Project Teams for early clinical development of a next generation anti-CD38 monoclonal antibody project, including Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan.

J ob Du ties and Responsibilities

  • Establish or adapt clinical development plans for the projects including discussions with clinical investigators, advisors and regulatory authorities and contingency planning.

  • Author protocol extended synopses, IB, clinical sections of IND/IMPD fillings, annual reports, development risk management plans. Lead and author clinical summaries and overview for regulatory submissions.

  • Present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and regulatory authorities, as appropriate

  • Author clinical abstracts, presentations for conferences, and manuscripts, when appropriate

Qualifications

  • 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 multifunctional team to achieve project milestones

  • Understanding of and willingness to meet applicable regulatory, quality and compliance standards

  • Position will be based in Vitry, France or Cambridge, MA, USA.

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.

#GD-SA #LI-SA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life