Clinical Research Director, I&I
BioSpace · Cambridge, MA · 3 days ago
On-siteAnalystFull-time
About The Job
Join the engine of Sanofis 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 and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
Main Responsibilities
- Scientific and technical expertise
- Contributes to the development of the clinical strategy and plan
- Led the development of the Abbreviated Protocol and Protocol development
- Represents the clinical function on Clinical Study Teams and other teams as appropriate
- Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
- Ensure that all development activities are targeted towards timely achievement (e.g. Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
- Interacts with opinion leaders and external consultants
- Regulatory Responsibilities
- Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
- Ensures clinical data meets all necessary regulatory standards
- Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
- Participates in Advisory Committee preparation
- Scientific data dissemination
- Ensures timely submission and dissemination of clinical data
- Supports the planning of advisory board meetings
- Establishes and maintains appropriate collaborations with knowledge experts
About You
- Medical Doctor with hematology/ transplant clinical expertise preferred
- At least 2 years experience in pharmaceutical drug development or clinical research
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
- Strong scientific and academic background with deep understanding of the disease
- Clinical research or pharmaceutical experience in the immunology/hematology/transplant field
- Knowledge of drug development and in immunology/ hematology/ transplant
- Good networking ability in cross-cultural environment
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Fully fluent in English (verbal and written communication)
Why Choose Us?
- 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 its through a promotion or a 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