Clinical Research Director, I&I

Sanofi • Cambridge, MA, United States • $200k - $250k / year • 1w ago

Clinical Research Director, I&I

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), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in areas such as Gastroenterology, Dermatology or Rheumatology, incorporate new methodologies and pro-actively progress study execution.

The CRD is responsible to:

create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
advance the CDP through internal management review
lead a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol
oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
contribute to data review, interpretation and publication of clinical study results
represent Clinical Development at Health Authorities and incorporate advice into development strategy
translate current understanding of disease pathogenesis into functional consequences and clinical outcomes
understand novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
understand the competitive environment
have established connections within the medical field of their expertise
have a credible publication record

Basic Qualifications:

Medical Doctor. Should be board certified or equivalent in rheumatology, pulmonology or dermatology or allergy/immunology
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
More than 5 years of relevant clinical, scientific and/or industry experience within the field of Gastroenterology, Rheumatology or Dermatology.
Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred
Knowledge of drug development preferred

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.

US and Puerto Rico Residents Only

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