**Location:** Cambridge, MA, Morristown, NJ* 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 in rare 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, preferably pulmonology, 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* 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.
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