Clinical Research Director - Immunology and Inflammation

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

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)