Clinical Research Director, I&I
Sanofi

Job title:Clinical Research Director (CRD)

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.

Our Team:

To support sustainable growth Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people.Therapeutic Areas lead the development of therapies by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT).

The Clinical Research Director (CRD) is the medical expert in the Development of R&D programs. The role requires a well-organized, strategically and, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple tasks.

Our Project:

Lunsekimig is a novel bi-specific nanobody targeting both TSLP and IL-13. Lunsekimig is in development across multiple immunology disease areas. We are seeking a highly motivated clinician-scientist to lead clinical trials in the respiratory space.

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:

The role of the CRD is to:

• Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
  
• Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
  
• Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc...)
  
• Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
  
• Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc...) and answer to questions from health authorities.
  
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
  

Key responsibilities include:

Leading the clinical development plan strategies

• Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
  
• Collaborate with other CRDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
  
• Raise study or project-level issues to the project head and propose related corrective action plans
  
• Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
  
• Collaborates with external partners, regulators, scientific experts and internal stakeholders
  
• Provide operational expertise to project clinical sub team, as needed
  
• Evaluates relevant medical literature and status from competitive products
  

Lead, Support and oversee the execution of clinical development and studies

• Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc...), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
  
• Develop the abbreviated protocol, the final protocol and protocol amendments
  
• Develop/review the Core Study Informed Consent Form (CSICF)
  
• Develop/review Study committee Charters
  
• Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
  
• Review and provide clinical input across different study documents Vendors RFPs, e-CRF, eCOA etc
  
• Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
  
• Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
  
• Answer to medical questions raised by HA, EC/IRBs, sites
  
• Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,...)
  
• Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
  
• Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support
  
• Co-Develop the SAP in collaboration with biostatistical team
  
• Responsible for key results preparation
  
• Develop/Review the clinical study report
  

Responsibilities related to regulatory and safety documents and meetings

• Review and/or contribute in the clinical section of the Investigator's brochure, CTA, IND, DSUR, DRMP, RMP
  
• Write/review the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
  
• Ensures clinical data meets all necessary regulatory standards
  
• Collaborates with the Patient Safety GSO to detect and document any safety signal
  
• Participates in Advisory Committee preparation
  

Scientific Data evaluation and authorship

• Participate and author manuscripts and abstracts
  
• Establish and maintains appropriate collaborations with knowledge experts or advisory boards
  
• Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams
  

About you

Experience:

• At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution. Background in respiratory, allergy, or immunology preferred.
  

Soft skills:

• Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
  
• Excellent problem solving capability
  
• Demonstrated capability to challenge decision and status quo with a risk-management approach
  
• Ability to negotiate to ensure operational resources are available for continued clinical conduct
  
• Very good teaching skills, demonstrated ability to assist and train others
  
• Ability to work within a matrix model
  
• International/ intercultural working skills
  
• Open-minded to apply new digital solutions
  

Technical skills:

• Understanding of pharmaceutical product development and life cycle management
  
• Very good Scientific and medical/clinical expertise
  
• Very good expertise in clinical development and methodology of clinical studies
  

Education:

• MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required
  

Languages:

• English fluent (spoken and written)
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

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