Clinical Research Director
About the Job
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?
Job Summary
Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned program(s) within the clinical development team, 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.
The clinical development team further develops a compound through life cycle management.
Job Duties and Responsibilities
Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to :
Authors abbreviated protocol.
Reviews the final protocol and protocol amendments.
Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
Reviews the study specific committee charters. Leads study specific committees with operational support.
Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine
Participates and contributes to regulatory and safety documents and discussions
Reviews and / or contributes clinical sections of the Investigator Brochure, IND / IMPD filings, DSUR, development risk management plans
Contributes to the clinical sections of the NDA / CTD, Briefing packages for regulatory meetings, PSP / PIP
Participates in Advisory Committee preparation
Scientific data evaluation and authorship
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate
Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate
About you
Job Requirements :
MD degree or equivalent, preferably with Hematology / Oncology fellowship or experience (3+ years) in hematological malignancies
Expertise in pharmaceutical medicine based on industry experience (2+ years) or academic clinical research experience (2+ years), preferably with experience in clinical development
Demonstrated ability to interact productively with 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 Cambridge, MA, USA or Bridgewater, NJ, USA.
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 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.
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Pursue , discover
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen.
So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at !
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