Sanofi
Biopharma
ClinicalResearchDirectorImmunologyandInflammation
“Clinical Research Director - Immunology and Inflammation at Sanofi. Skills: Immunology, Inflammation, Clinical research, Drug development. Develop clinical trials. Execute clinical trials”
Industry & Context.
Analytical skills
What They're Looking For.
Must Have
Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise, Minimum 2 years experience in pharmaceutical drug development, Minimum 2 years experience in clinical research, Clinical research or pharmaceutical experience medicine experience in transplant/immunology field, Knowledge of drug development, Knowledge of immunology, Fluent in English (verbal and written communication)
Nice to Have
Phase 3 experience, Proven record of scientific achievement, Presentations in peer-reviewed journals, Successful completion of major clinical studies, Successful completion of submissions, Knowledge on antibody is a plus
What You'll Do.
Develop clinical trials
Execute clinical trials
Report clinical trials
Develop abbreviated protocol
Develop clinical protocol
Participate in protocol review
Participate in study report review
Participate in labeling review
Support interactions with regulatory agencies
Support interactions with ethics committees
Maintain scientific expertise
Maintain technical expertise
Maintain clinical expertise
Evaluate medical literature
Maintain visibility within dermatology field
Contribute to clinical strategy
Contribute to clinical plan
Lead protocol development
Represent clinical function on teams
Provide input into Translational Medicine Plan
Define biomarker strategy
Increase knowledge about pathway
Increase knowledge about drug effects
Target development activities for timely achievement
Interact with opinion leaders
Interact with external consultants
Serve as medical monitor
Represent Division at regulatory agency meetings
Ensure clinical data meets regulatory standards
Support registrations
Support label submissions
Support label modifications
Contribute to Briefing Package
Participate in Advisory Committee preparation
Ensure timely submission of clinical data
Ensure timely dissemination of clinical data
Support planning of advisory board meetings
Establish collaborations with knowledge experts
Maintain collaborations with knowledge experts
Ensure GPT activities compliance
Ensure compliance with regulations
Ensure compliance with laws
Ensure compliance with guidance from FDA
Ensure compliance with guidance from EMEA
Ensure compliance with guidance from CHMP
Ensure compliance with Sanofi policies
Ensure compliance with Sanofi procedures
How You'll Work.
Team & Collaboration
Matrix team; Clinical Study Teams; Global Project Team
Communication Scope
Interpersonal skills; Communication skills; Presentation skills; Negotiation skills; Written communication
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