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Clinical Research Director I&I

Synthorx

Synthorx

Cambridge, MA, USA
Posted on Monday, April 8, 2024

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?

The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.

Scientific and technical expertise

  • Has and maintains deep scientific, technical and clinical expertise in respiratory/immunology field

  • Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage

  • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus

  • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

Clinical research planning and execution

  • Contributes to the development of the clinical strategy and plan

  • Leads the development of the Abbreviated Protocol and Protocol development

  • Represents the clinical function on Clinical Study Teams and other teams as appropriate.

  • Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug

  • Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)

  • Interacts with opinion leaders and external consultants

In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.

Basic Qualifications

  • Medical Doctor with dermatology/allergy/immunology clinical expertise preferred

  • Translational research experience preferred, especially analyzing multiomic outputs to identify gene/protein dysregulation and its application to dermatology, respiratory, rheumatologic and gastrointestinal diseases

  • Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus

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 progress, discover extraordinary

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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!