Clinical Research Director, Immunology & Inflammation (Rheumatology)

Sanofi•Cambridge, MA

21h

About The Position

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. Position Overview: 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 rheumatologic diseases, incorporate new methodologies, and pro-actively progress study execution. The role will focus on developing innovative therapies for autoimmune and inflammatory diseases, with a particular emphasis on rheumatology. 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?

Requirements

MD or MD/PhD in a relevant scientific discipline with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
Have experience in novel approaches to translational medicine
Have and maintain deep scientific, technical and clinical knowledge in immunologic/rheumatologic diseases
Expertise in autoimmune and inflammatory diseases, particularly in rheumatology
Demonstrate 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
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences
Proven track record of scientific publications and presentations at international conferences

Responsibilities

Create clinical development strategy and plans for one or more assets
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the clinical development plan through internal management review
Lead a clinical sub team to design clinical studies and to create study protocols
Execute the clinical development plan in close collaboration with clinical operations
Advance scientific and clinical knowledge for immunology in rheumatologic diseases
Incorporate new trial, scientific and digital methodologies
Pro-actively progress study execution
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
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)
Serve as a medical expert and provide strategic input to early-stage programs
Collaborate with external experts, key opinion leaders, and investigators to advance clinical research
Represent Sanofi at scientific conferences and regulatory meetings

Benefits

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.

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