Sanofi
biopharma
ClinicalResearchDirector
“Clinical Research Director at Sanofi. Skills: Clinical Research Director, Immunology & Inflammation (I&I) Therapeutic Area, clinical development plans, respiratory assets, scientific and clinical knowledge in immunology in respiratory, allergy, or immunology, innovation and new methodologies, study execution. creation and execution of clinical development plans for respiratory assets. advance the CDP through internal management review”
What You'll Achieve.
drive breakthroughs that could turn the impossible into possible for millions; advance scientific and clinical knowledge; pro-actively progress study execution; Advance the CDP through internal management review; Support drug registrations; publication of clinical study results; incorporate advice into development strategy; incorporate pertinent advice and learnings into the internal program; Translate biology into clinic
Industry & Context.
Demonstrated problem solving skills; Excellent problem-solving, conflict-resolution and decision-making skills
What They're Looking For.
Must Have
Medical Doctor, board certified or equivalent in Pulmonary Medicine, Allergy, Dermatology, and/or immunology, or other specialty with drug development background, completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent, More than 5 years of clinical or scientific research experience, more than >5 years industry experience, interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment, Performance oriented with ability to work along agreed timelines and a focus on strategy and execution, Outstanding communicator, Excellent problem-solving, conflict-resolution and decision-making skills, Fluent in English (verbal and written communication)
Nice to Have
scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area, Knowledge of drug development
What You'll Do.
creation and execution of clinical development plans for respiratory assets
advance the CDP through internal management review
Oversee the execution of clinical studies in compliance with internal SOPs
ICH guidelines and other regulations
Review documents supporting clinical development
Support drug registrations
Contribute to data review
interpretation and publication of clinical study results
Represent Clinical Development at Health Authorities
Maintain or establish interaction with external scientific and clinical communities
Translate biology into clinic
Evaluate clinical aspects of business development opportunities
How You'll Work.
Team & Collaboration
collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing; collaboration with external partners, regulators, and diverse internal stakeholders and collaborators; interaction with external scientific and clinical communities; close collaboration with research and translational medicine
Communication Scope
interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment; Outstanding communicator; Excellent problem-solving, conflict-resolution and decision-making skills; Fluent in English (verbal and written communication)
Process & Methodology
execution of clinical development plans, progress study execution, work along agreed timelines, focus on strategy and execution
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