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For Companies Location: Cambridge, MA or 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. As the Senior Clinical Research Director (Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver multiple operational tasks.
Main Responsibilities:
- 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 CRDs 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 operational development activities pertaining to study start-up.
- Provide appropriate medical input & support for all activities related to clinical studies conduct.
- Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies.
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP).
- Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy.
- Prepares Internal Governance documents and contributes to the medical aspects of the TPP, TVP and other GPT documents.
- Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders.
- Raise study or project-level issues to the project head and propose related corrective action plans.
- 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 activities.
- Collaborate and communicate appropriately with all function stakeholders.
- 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.
- Review and provide clinical input across different study documents.
- Ensure quality of clinical data through continuous data validation.
- Ensure trial master file documents readiness and availability.
- Lead the study specific committees with operational support.
- Co-Develop the SAP in collaboration with biostats.
- Responsible for key results preparation.
- Develop/Review the clinical study report.
- Represent project in interactions with regulatory bodies.
- Develop and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP.
- Ensure clinical data meets all necessary regulatory standards.
- Participate and author manuscripts and abstracts.
- Establish and maintain appropriate collaborations with knowledge experts or advisory boards.
About You
Experience: At least 4 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in a Healthcare institution.
Soft skills: Very good communication skills (verbal and written), excellent problem solving capability, quality-focused, multiple tasks handling and prioritization, ability to negotiate, mentoring skills.
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: Medical Doctor (MD) preferred; GP or specialist; training in pediatrics or pediatric neurology is a plus.
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. Enjoy a thoughtful, well-crafted rewards package that recognises your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits.
Senior Clinical Research Director, Rare in Cambridge employer: Sanofi
Contact Detail:
Sanofi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Research Director, Rare in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their mission and values, especially in the RARE Therapeutic Area. Tailor your responses to show how your experience aligns with their goals and how you can contribute to their innovative research.
✨Tip Number 3
Practice your pitch! Be ready to explain your background, skills, and what makes you a great fit for the Senior Clinical Research Director role. Keep it concise but impactful, highlighting your medical expertise and leadership abilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Sanofi and contributing to groundbreaking research.
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Clinical Research Director role. Highlight your relevant experience in clinical development and showcase how your skills align with our mission at Sanofi.
Showcase Your Soft Skills: We value emotional intelligence and problem-solving abilities. In your application, share examples of how you've successfully navigated challenges and collaborated with diverse teams in previous roles.
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon. We want to see your qualifications without having to sift through unnecessary fluff!
Apply Through Our Website: For the best chance of success, make sure to submit your application through our official website. This way, we can easily track your application and ensure it reaches the right people.
