Clinical Research Director

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* Job Title:

** Clinical Research Directors

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* Location:

** Morristown, NJ Cambridge, MA

** 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.

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

** 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.

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* Main Responsibilities:

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* + 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.

+ Align company position on clinical strategy with partner in alliance projects.

+ Translate biology into clinic in close collaboration with research and translational medicine.

+ Evaluate clinical aspects of business development opportunities as needed.

+ Apply high ethical standards and work with integrity.

** Scientific and Technical Expertise:*
* + This position requires a strong scientific and clinical foundation in gastroenterology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.

+ 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 Gastroenterology.

+ 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.

+ Understand the competitive environment.

+ Have established connections within the medical field of their expertise.

+ Have a credible publication record.

** About You*
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* Basic Qualifications:

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* + Medical Doctor. Should be board certified or equivalent in gastroenterology 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 clinical or scientific and/or more than 10 years industry experience within the field of gastroenterology.

+ 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.

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

+ Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.

+ Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills.

+ Fluent in English (verbal and written…