Senior Clinical Research Director - Bone Marrow Transplantation

Job Title: Senior Clinical Research Director - Bone Marrow Transplantation

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Reporting to the Global Project Head (GPH), the Clinical Leader will be responsible for leading the execution of the clinical development strategy of the assigned ph 3 and ph 2 programs, and for leading the clinical evaluation of business development opportunities within the stem cell transplant program.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Supervises study Clinical Research Directors / Clinical Scientist of assigned ongoing clinical trials

• Collaborates with cross functional teams from Clinical Operations, Medical, Biostatistics, Regulatory, Translational Medicine, Clinical Pharmacology, Health Access, Project Management and Pharmacovigilance on assigned programs

• Establishes or adapts clinical development strategy for the program including discussions with clinical investigators, advisors and regulatory authorities

• Works with GPH to evaluate business development opportunities and future clinical development programs within stem cell transplant

• Supervises the authoring of protocol extended synopses, clinical sections of Investigator Brochure, clinical sections of IND/IMPD fillings, annual reports, development risk management plans.

• Leads the clinical interpretation of study results within the program, and leads the generation of clinical study reports and clinical summaries, including regulatory submissions.

• Presents clinical program plans or results to health authorities, and leads response to clinical questions from health authorities

• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical programs within a matrix environment

• Presents and discusses clinical development strategy results with key internal stakeholders including governance bodies

• Assists the authoring of clinical abstracts, presentations for conferences, and manuscripts, when appropriate

About You

Job Requirements:

• Medical degree required

• Oncology and/or Hematology fellowship training or significant clinical experience (6+ years) in Oncology and/or Hematology (required)

• 5+ years clinical practice in bone marrow transplantation (required)

• 5+ years experience in translational or clinical trials as investigator in academia or study lead in industry (preferred)

• Ability to work independently and work with other team members to execute clinical development plans

• Demonstrated ability to interact productively with and attract top external investigators

• Demonstrated ability to communicate in various scientific and internal governance committees

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

• Proficiency in speaking and writing in English

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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