Clinical Research Director - Immunology and Inflammation

Job title:

Clinical Research Director - Immunology and Inflammation

Location:

Cambridge, MA / Morristown, NJ

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, Solid Organ Transplant focus, 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.

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:_

Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.

Scientific and technical expertise

• Has and maintains deep scientific, technical and clinical expertise in transplant, nephrology, hepatology and/or immunology/inflammation 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 dermatology field to maintain credibility with internal and external stakeholders

Clinical research planning and execution

• 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
• Serve as medical monitor for the studies assigned

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

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.

About You

Basic Qualifications:

• Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
• Minimum 2 years experience in pharmaceutical drug development and/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 transplant/immunology field
• Knowledge of drug development and in immunology
• 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)