Global Clinical Development Strategy Expert

Sanofi; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Job summary

Sanofi seeks a Global Clinical Development Strategy Expert to drive clinical development strategy and execution for acne vaccine and related targets. You will lead a Clinical Team and collaborate across monitoring, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs to ensure rigorous, compliant development.

You will shape the development plan, manage licensure evidence, and interact with authorities while upholding Sanofi SOPs and fostering external

Qualifications

• MD or PhD with extensive clinical development experience.
• Experience leading cross-functional clinical teams.
• Proven track record in vaccine or therapeutics development.

Responsibilities

• Define the strategic clinical development plan aligned with global R&D strategy and regulatory needs.
• Lead the Clinical Team and support monitoring, data management, statistics, medical writing, pharmacovigilance and regulatory affairs.
• Manage the clinical development process from early-stage to licensure and evidence generation.
• Collaborate with pharmacovigilance to define safety surveillance and risk management plans.
• Prepare key clinical documents (protocols, reports) and CTD submissions for authorities.
• Ensure SOPs align with Sanofi standards and continuously improve processes.
• Build a network of internal and external collaborators and authorities.

Skills

Clinical development strategy

Leadership

GCP/ICH experience

Regulatory submissions

Vaccine/therapeutics development

Education

MD or PhD in life sciences

Job description

About The Job

As Global Clinical Development Strategy Expert within our Global Clinical Development Department, you will be a key member of the Project Team and Clinical Team, responsible for clinical development strategy and execution. You will primarily focus on clinical trials in the context of Acne therapeutic vaccine development and New Targets projects, though responsibilities may extend to other vaccine areas within Sanofi's flexible model. You will lead the Clinical Team to ensure that clinical development strategy is executed according to adequate processes with the highest clinical and medical scrutiny. Ready to get started?

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.

Key Responsibilities

• Define the strategic clinical development plan in line with global R&D strategy, franchise strategy, and regulatory needs, and present for endorsement with appropriate governance committees
• Lead the Clinical Team and support different functions (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) with expertise and leadership
• Manage the clinical development process from early-stage development through licensure, providing clinical leadership for evidence generation that supports licensure and commercialization
• Work closely with the pharmacovigilance department to define safety surveillance processes during clinical development and design the safety risk management plan
• Lead preparation of key clinical documents for clinical trials (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities
• Ensure operational development processes align with Sanofi Standard Operating Procedures and help review and improve current SOPs
• Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators, and competent authorities

About you

• MD with specialization in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD in a life science area (Biology, Immunology, Pharmacology, or related field) with extensive clinical development experience.
• 5-10+ years of experience in clinical development with demonstrated expertise in vaccine or therapeutics development and clinical strategy in academia, non-profit, government or industry.
• Experience working according to GCP/ICH guidelines.
• Proven ability to lead and manage transversal teams with excellent interpersonal skills.
• Experience with regulatory submissions and interactions with health authorities.

Technical And Soft Skills

• Background in clinical immunology is welcome.
• Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine preferred.
• Experience with therapeutic vaccines, particularly for dermatological conditions such as Acne, and any later stage development is highly valued.
• Excellent oral and written communication skills in English.
• Considerable degree of autonomy with ability to act for change and empower others.
• Ability to work in diverse environments with different stakeholders

Languages

Excellent command of oral and written English

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

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.

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 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 #vhd 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.