Clinical Research Director, Immunology & Inflammation (Rheumatology)
- 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
- 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
- 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.
#LI-SA #LI-Onsite #vhd 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.
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