Clinical Research Director; CRD), Rare Diseases

Position: Clinical Research Director (CRD), Rare Diseases
*
* 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.
#J-18808-Ljbffr