Clinical Research Director

Sanofi • Cambridge, MA

23h • Onsite

About The Position

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. Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Their deep understanding of the immune system – and innovative pipeline – enables them to invent medicines and vaccines that treat and protect millions of people around the world. Together, they chase the miracles of science to improve people’s lives.

Requirements

• Strong scientific and clinical experience and skills
• Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
• Experienced in advancing assets from discovery into clinical development
• Experience in novel approaches in translational medicine
• Have and maintain deep scientific, technical and clinical knowledge in pulmonary, allergy, dermatology or immunology, or demonstrate strong experience in drug development
• Demonstrated problem solving skills
• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
• Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
• Understand novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
• Understand the competitive environment
• Have established connections within the medical field of their expertise
• Have a credible publication record
• Medical Doctor
• Board certified or equivalent in Pulmonary Medicine, Allergy, Dermatology, and/or immunology, or other specialty with strong 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 and/or more than >5 years industry experience
• Knowledge of drug development
• Strong 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 Haves

• Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred

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 clinical study results
• Represent Clinical Development at Health Authorities and incorporate advice into development strategy
• Maintain or establish interaction with external scientific and clinical communities and incorporate pertinent advice and learnings into the internal program
• Translate biology into clinic in close collaboration with research and translational medicine
• Evaluate clinical aspects of business development opportunities as needed
• Apply high ethical standards and work with integrity

Benefits

• Endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave
• Employee benefit programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree