Clinical Research Director, I&I (IBD)

Job Title: Clinical Research Director, I and I, IBD

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.

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, and to incorporate new methodologies and pro-actively progress study execution.   

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:

• 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

• Leads 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 incorporating advise into development strategy

• Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program

Scientific and technical Expertise:

This position requires a strong scientific and clinical foundation in internal medicine. Gastroenterology is a plus. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.

The candidate must

• Be experienced in advancing assets from discovery into clinical development

• Have experience in novel approaches in translational medicine

• Have and maintain deep scientific, technical and clinical knowledge in immune driven disease and clinical immunology. Gastroenterology is a plus.

• Demonstrated problem solving skills 

• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area

• Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome

• Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods

About You

Basic Qualifications:

• Medical Doctor. Should be board certified or equivalent in internal medicine / clinical immunology. Gastroenterology is a plus

• 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 immune driven diseases. Gastroenterology is a plus.

• Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience internal medicine, clinical immunology. Gastroenterology is a plus

• Knowledge of drug development preferred

• Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment

• Performance oriented with ability to work along agreed timelines

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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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.