Sanofi
biopharma
ClinicalResearchDirector
Neural analysis suggests this role is
optimal for Director candidates.
“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. advancing the CDP through internal management review”
What You'll Achieve.
drive breakthroughs that could turn the impossible into possible for millions; advance the CDP through internal management review; pro-actively progress study execution; Support drug registrations; incorporate advice into development strategy; incorporate pertinent advice and learnings into the internal program; deliver compelling growth
Industry & Context.
Demonstrated problem solving skills; Excellent problem-solving skills; conflict-resolution skills; 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, 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
advancing 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; collaboration with internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing; collaboration with external partners; collaboration with regulators; collaboration with diverse internal stakeholders and collaborators
Communication Scope
interpersonal skills; communication skills; presentation skills; negotiation skills; networking skills; Outstanding communicator; Fluent in English (verbal and written communication)
Process & Methodology
execution of clinical development plans, progress study execution, work along agreed timelines
Full Job Description
**Job Title:** Clinical Research Director **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 & Inflammation (I&I) Therapeutic Area will be responsible for creation and execution of clinical development plans for respiratory assets within the portfolio. The CRD is expected to advance scientific and clinical knowledge for immunology in respiratory, allergy, or immunology, incorporating innovation and new methodologies, and pro-actively progress study execution. **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:**_ * Lead the clinical development strategy for one or more assets in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing * Advance the CDP through internal management review * Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations * Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval * Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation) * Contribute to data review, interpretation and publication of
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