Sanofi
Clinical Research Director
The Clinical Research Director in Immunology and Inflammation Therapeutic Area leads the development, execution, and reporting of clinical trials supporting product registration. The role involves developing clinical protocols, reviewing study documents, and supporting regulatory and ethics committee interactions while operating independently and within matrix teams.
Key Responsibilities
- • Has and maintains deep scientific, technical and clinical expertise in the immunology/ transplant/ hematology field.
- • Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage.
- • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus.
- • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products.
- • Maintains visibility within the immunology/ transplant field to maintain credibility with internal and external stakeholders.
- • Contributes to the development of the clinical strategy and plan.
- • Leads 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.
- • 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.
- • Ensures timely submission and dissemination of clinical data.
- • Supports the planning of advisory board meetings.
- • Establishes and maintains appropriate collaborations with knowledge experts.
- • Ensures that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
Required
- • 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 medicine 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.
- • Fluent in English (verbal and written communication).
Benefits & Perks
- • 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 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.
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Series B
Raised $50M Series B funding - Jan 2024
Award
Named "Best Healthcare Startup" by TechCrunch - Dec 2023
Growth
Expanded to 5 new states - Nov 2023
Job Title: Clinical Research Director
Location: Morristown, NJ, Cambridge, MA
About The Job
Join the engine of Sanofi’s 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.
The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. They must be able to comfortably operate independently and within a matrix team, both face to face and remotely.
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities
Scientific and technical expertise
Basic Qualifications
#GD-SA
#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.
Location: Morristown, NJ, Cambridge, MA
About The Job
Join the engine of Sanofi’s 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.
The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. They must be able to comfortably operate independently and within a matrix team, both face to face and remotely.
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities
Scientific and technical expertise
- Has and maintains deep scientific, technical and clinical expertise in the immunology/ transplant/ hematology field.
- Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage.
- Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus.
- Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products.
- Maintains visibility within the immunology/ transplant field to maintain credibility with internal and external stakeholders.
- Contributes to the development of the clinical strategy and plan.
- Leads 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.
- 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.
- Ensures timely submission and dissemination of clinical data.
- Supports the planning of advisory board meetings.
- Establishes and maintains appropriate collaborations with knowledge experts.
- In addition to the above activities the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
Basic Qualifications
- 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 medicine 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.
- Fluent in English (verbal and written communication).
- 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 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.
#GD-SA
#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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