Senior Clinical Lead, Early Clinical & Experimental Therapeutics

Sanofi; Amsterdam; Hybrid; EUR 113,000 - 150,000; Full time

Benefits offered by this job

High-quality healthcare

Wellness programs

14 weeks parental leave (gender‑neural

Career development opportunities

Job summary

Sanofi is seeking a Senior Clinical Lead in Amsterdam to steer early oncology trials from First-in-Human to Proof-of-Concept within Translational Medicine. You will integrate preclinical insights, biomarkers, and pharmacology to shape strategies and enable Go/No-Go decisions.

You will manage study design, safety monitoring, and dose escalation while coordinating regulatory, biostatistics, and CRO activities. English fluency and an MD or MD/PhD are required for this global role.

Qualifications

• Clinical research experience including oversight of early Phase 1/2a trials.
• Proven ability to design and execute early development studies in pharma or CROs.
• Experience with translational/biomarker research and safety oversight.
• Strong leadership in cross-functional teams and risk management.
• Knowledge of GCP and use of emerging digital/AI-driven tools.

Responsibilities

• Design and lead early clinical studies (FIH, POC) for oncology assets.
• Integrate preclinical data into early development plans supporting validation.
• Serve as Study Medical Manager: study prep, safety monitoring, dose decisions.
• Lead cross-functional teams including regulatory, safety, PK, biomarker, CRO oversight.
• Make frontline protocol decisions; ensure scientifically sound, high-standard execution.
• Author protocols, ICFs, brochures, reports, and regulatory submissions.
• Engage investigators, ethics committees, health authorities to advance pipeline.
• Present data at meetings; act as internal consultant for therapeutic areas.

Skills

Clinical research leadership

Cross-functional leadership

GCP knowledge

AI tools

Communication skills

English fluency

Education

MD

MD/PhD

Tools

AI tools

Digital tools

Biomarker analysis tools

Job description

About the Job

As Senior Clinical Lead, Early Clinical & Experimental Therapeutics within our Translational Medicine Unit, you'll be at the forefront of oncology drug development—designing and leading early clinical studies that could transform treatment options for patients with solid tumors and hematologic malignancies. Ready to get started? This is a rare opportunity to shape the clinical development of a RAS-associated pathway inhibitor—both as monotherapy and in combination with agents of varied modality—while also helping translate a portfolio of preclinical assets into first-in-human studies. You'll work at the exciting intersection of deep immunoscience, AI-powered research, and bold clinical innovation, addressing significant unmet needs in oncology. You'll be an integral member of asset Global Project Teams and Translational Medicine Subteams, guiding assets from preclinical development through Phase 2a. Your work will span the full early development journey—from natural history studies and experimental model validation to Proof-of-Mechanism and Proof-of-Concept trials—contributing directly to Human Target Validation and Go/No Go decisions that shape Sanofi's oncology pipeline. Success in this role requires close collaboration with research scientists, toxicologists, pharmacokineticists, biomarker experts, and late-phase clinicians, as well as operational coordination across regulatory, safety, biostatistics, and clinical operations functions including CRO oversight. Your ability to integrate outputs from multiple disciplines into a coherent translational medicine plan will be essential to driving meaningful progress for patients.

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

• Design and lead early clinical studies including First-in-Human, natural history, mechanistic, signal-seeking, Proof-of-Mechanism, and Proof-of-Concept trials for oncology assets such as small molecules, monoclonal antibodies, antibody drug conjugates, and immune cell engagers
• Drive translational strategy by integrating preclinical data, biomarker insights, and pharmacological evidence into coherent early development plans that support Human Target Validation
• Serve as Study Medical Manager for selected clinical studies, overseeing study preparation, conduct, safety monitoring, dose escalation decisions, and final reporting
• Lead cross-functional teams coordinating regulatory, safety/pharmacovigilance, biostatistics, biomarker, PK, and clinical operations functions including CRO oversight
• Make front-line clinical decisions on protocol design, dose escalation, safety monitoring, and regulatory submissions, ensuring studies are scientifically sound and executed to the highest standards
• Author and review key clinical documents including protocols, informed consent forms, investigator brochures, clinical study reports, regulatory submissions, and scientific publications
• Engage with internal and external stakeholders including investigators, key opinion leaders, ethics committees, health authorities, and cross-functional colleagues to advance the oncology pipeline
• Present data and insights at internal and external scientific meetings, serving as an expert and internal consultant for assigned therapeutic areas

Key Internal & External Relationships

Internal Collaborators: Translational Medicine Unit departments (Biomarkers & Precision Medicine, Preclinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations, Evidence Generation & Decision Science) Bench research and toxicology colleagues for target validation and asset suitability assessment Clinical Trial Managers and Data Managers for operational support Regulatory Affairs, Patient Safety & Pharmacovigilance, and Oncology Development Groups

External Partners: Clinical investigators and site service providers Early-phase Clinical Research Organizations and clinical trial vendors Clinical and scientific experts, Key Opinion Leaders Ethics committees and Health Authority representatives

About You

Experience: Clinical research experience including oversight of patients on early Phase 1/2a clinical trials; proven track record in designing and executing early development studies in pharmaceutical industry, academic institutions, or clinical research organizations; experience with medical safety oversight and translational/biomarker research

Leadership Skills: Demonstrated ability to lead cross-functional teams in a matrix organization; strong capability to challenge decisions and the status quo with a risk-management approach; effective international and intercultural working skills

Technical Skills: Broad biomedical knowledge applicable to nonclinical and clinical experiment design; demonstrated knowledge of GCP practices; experience using emerging digital and AI-driven tools; ability to acquire and apply new technical skills rapidly

Communication: Excellent verbal and written communication skills appropriate for global interactions across functional areas, CROs, and regulatory agencies

Languages: Fluent English (written and spoken)

Education: Advanced degree (M.D. or M.D./Ph.D.) required; M.D. + Ph.D. or equivalent bench science experience strongly preferred

Preferred Qualifications: Experience in global pharmaceutical settings Medical and/or scientific experience with combination therapies and drugs targeting cytoplasmic signaling pathways Postgraduate residency training and laboratory research experience in industry or academia Experience in the conduct of late-phase clinical trials

Why Choose Us?

• Pioneer oncology breakthroughs by leading early clinical development of cutting-edge assets including RAS pathway inhibitors and novel combination therapies
• Work at the frontier of AI-powered research, leveraging digital tools to accelerate drug development and improve patient outcomes
• Collaborate globally with world-class scientists, clinicians, and researchers across multiple locations and disciplines
• Shape the future of cancer treatment through translational medicine strategies that bridge preclinical discovery and clinical proof-of-concept
• Drive meaningful decisions with real authority over protocol design, dose escalation, and Go/No Go recommendations
• Grow your expertise with endless opportunities for career development across functions, regions, and the full product lifecycle
• Enjoy comprehensive benefits including high-quality healthcare, wellness programs, and at least 14 weeks' gender-neutral parental leave

#LI-EUR #LI-HYBRID

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.

We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.

Salary and Benefits

The salary range for this position is :€112.800,00 - €150.400 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs. We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth.