- Working within a matrix model, establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors and regulatory authorities.
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans.
- Lead the clinical interpretation of study results
- Contributes to clinical study reports and clinical summaries, including regulatory submissions.
- Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial
- Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities
- Author clinical abstracts, presentations for conferences, and manuscripts
- Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus.
- At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution
- Excellent communication skills (verbal and written English) with both internal and external stakeholders
- Adept at problem solving
- Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach
- 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.
- Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions
- International/ intercultural working skills
- 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.
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Clinical Research Director - Cambridge - Eacademy Sanofi
Description
Job Title: Clinical Research Director - Oncology
Location: Cambridge, MA, Morristown, NJ
About the Job
Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
As a Senior Clinical Research Director (Senior CRD) within the Oncology Therapeutic Area, you will lead the clinical trial strategy for one or more multiple myeloma assets, creating synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities
About You
Education
Experience
Soft skills
Preferred location is Cambridge, MA. Morristown, NJ and Vitry, France considered.
Why Choose Us?
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
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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