Senior Clinical Research Director

Sanofi; Cambridge, Northern (MA, KY); On-site; USD 236,000 - 394,000; Full time

Benefits offered by this job

Health and wellbeing benefits

Parental leave (14 weeks)

Diversity and inclusion programs

Job summary

Sanofi is seeking a Senior Clinical Research Director in Cambridge, MA to lead the fitusiran registrational program and global regulatory submissions. You will develop the clinical development plan and oversee studies across functions to ensure consistency and quality.

The role requires a Medical Doctor with 8+ years of experience, strong leadership, and fluency in English. MD/PhD is preferred. This position is based in Cambridge, MA with responsibilities spanning global programs.

Qualifications

• Medical Doctor or equivalent with specialist training in Hematology, Internal Medicine, Pediatrics, or other relevant specialty
• Minimum 8 years experience
• English fluent (spoken and written)

Responsibilities

• Develop and implement clinical development plan strategies.
• Lead, support, and oversee the execution of clinical development and study activities.
• Collaborate with functions to ensure a uniform, aligned operational approach.
• Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related clinical study issues.
• Contribute to the clinical part of submission dossiers for projects, including responsibilities related to regulatory and safety documents and meetings.
• Serve as the medical reference in the team, ensuring the medical relevance of clinical data.
• Lead scientific data evaluation and dissemination.
• Foster compliance with current regulations, laws and HA guidance as well as Sanofi policies and procedures.

Skills

Clinical development

Leadership

Regulatory submissions

Cross-functional collaboration

English fluency

Medical knowledge

Education

Medical Doctor or equivalent

MD/PhD degree (preferred)

Job description

Job title: Senior Clinical Research Director Location: Cambridge, MA

About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Fitusiran Clinical Team as Senior Clinical Research Director, where you will serve as the primary Clinical Lead for the fitusiran registrational development program and ongoing global regulatory submissions. Qfitlia® (fitusiran) is a first-in-class antithrombin-lowering therapy approved in the United States and multiple countries for the prophylactic treatment of adults and adolescent patients with hemophilia. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. 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.

Main responsibilities:

• Develop and implement clinical development plan strategies.
• Lead, support, and oversee the execution of clinical development and study activities.
• Collaborate with functions to ensure a uniform, aligned operational approach.
• Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related clinical study issues.
• Contribute to the clinical part of submission dossiers for projects, including responsibilities related to regulatory and safety documents and meetings.
• Serve as the medical reference in the team, ensuring the medical relevance of clinical data.
• Lead scientific data evaluation and dissemination.
• Ensures strict compliance with current regulations, laws and HA guidance as well as with Sanofi’s policies and procedures.
• Foster a collaborative, engaging, and high-performing team environment for Clinical Research Directors and Clinical Scientists.

About you Minimum Requirements:

• Medical Doctor or equivalent with specialist training in Hematology, Internal Medicine, Pediatrics, or other relevant specialty
• Minimum 8 years experience

Basic Qualifications:

• Strong scientific and clinical background with deep understanding of the therapeutic field
• Expertise in clinical development and methodology of clinical studies
• Understanding of pharmaceutical product development and life cycle management
• Excellent communication, problem solving and decisions making skills for interactions across functional areas and for interactions with key regulatory agencies.
• Strong leadership and collaboration abilities, including the capacity to inspire and guide cross functional teams towards achieving project and team goals.
• English fluent (spoken and written)

Preferred Qualifications:

• MD/PhD degree

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.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Employees may be eligible to participate in Company employee benefit programs.
• Additional benefits information can be found through the LINK.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

#GD-SA #LI-SA #vhd #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmitive Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is: $236,250.00 - $393,750.00 All compensation will be determined commensurate with demonstrated experience.

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.