Clinical Research Director, Immunology and Inflammation

Clinical Research Director, Immunology and Inflammation

Sanofi

Gentilly, France

About the job

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.

Main responsibilities

Scientific and technical expertise:

• Has and maintains deep scientific, technical and clinical expertise in 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.

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.

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

Experience:

• Medical Doctor (MD) required; hematology or transplant clinical expertise strongly preferred;
• Minimum 2 years of experience in pharmaceutical drug development or clinical research;
• Clinical research or pharmaceutical medicine experience in the immunology/hematology/transplant field required.

Soft and Technical Skills:

• Strong scientific and academic background with deep understanding of disease pathology;
• Knowledge of drug development in immunology/hematology/transplant;
• Understanding of antibody therapeutics is advantageous;
• 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;
• Cultural sensitivity and flexibility to work across global teams;
• Adaptability to different time zones and remote collaboration;
• Good networking ability in cross-cultural environments;
• 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.

Education:

• Medical Doctor (MD) required.

Languages:

• Fluency in spoken and written English required (for global collaboration with US and European teams). French: Not required (nice to have for France-based positions).