Clinical Lead / Clinical Lead

Join Our Team as a Clinical Development Lead

Are you an experienced clinical development professional eager to take scientific ownership of a clinical program and help shape the future of a differentiated compound? We are searching for a scientifically curious, strategic, and hands-on Clinical Development Lead to provide clinical and scientific leadership throughout the design, execution, and interpretation of clinical studies.

In this pivotal role, you will translate scientific insights into high-quality clinical evidence and make decisions that can significantly impact patient outcomes. Collaborating closely with Clinical Operations, Regulatory Affairs, Drug Safety, Biostatistics, and other cross-functional partners, you will ensure the clinical program is scientifically robust, operationally feasible, and aligned with the compound’s development objectives. This is an opportunity to combine scientific expertise with visible cross-functional leadership in a dynamic, entrepreneurial, and collaborative environment.

Key Responsibilities

The Clinical Development Lead will be responsible for leading the delivery of clinical program objectives for an assigned compound, aligned with company strategy and development plans. Main responsibilities include:

• Lead the Clinical Team at the project level, providing clear scientific direction, alignment, and guidance across the clinical program; may also involve line management responsibilities.
• Oversee the scientific development and delivery of clinical sections of trial and program-level regulatory documents, including Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities.
• Drive the clinical component of the development program in partnership with global line functions, ensuring scientific quality, clear priorities, and timely delivery.
• Provide ongoing clinical and scientific review, interpretation, and communication of clinical trial data to inform program strategy and development decisions.
• Serve as a core member of the Safety Management Team and contribute to the assessment and communication of the compound’s benefit-risk profile.
• Support the preparation of safety-related documents, including Periodic Safety Update Reports and other safety documentation, collaborating with the Project Physician and Drug Safety Physician.
• Maintain a strong understanding of the therapeutic area, competitive landscape, relevant mechanisms of action, and evolving standards of care.
• Lead clinical contributions to scientific communications, including study abstracts, posters, oral presentations, and manuscripts.
• Represent the clinical perspective in cross-functional discussions and contribute to the continuous evolution of the clinical development strategy.

Candidate Requirements

• Advanced degree in life or health sciences, such as a PhD, PharmD, MD, MSc, or equivalent.
• At least seven years of relevant experience in clinical development within the pharmaceutical or biotechnology industry.
• Proven expertise in planning, executing, reporting, and publishing Phase II to IV clinical trials in a global, cross-functional matrix environment.
• Demonstrated experience in leading clinical projects or substantial clinical development workstreams to completion.
• Strong background in preparing clinical and regulatory documentation, including Investigator’s Brochures, protocols, briefing books, and clinical study reports.
• Experience with regulatory submissions such as INDs, NDAs, and MAAs, including interactions with Health Authorities.
• Excellent understanding of global drug development, from first-in-human studies through post-approval activities.
• Strong knowledge of clinical trial design methodology and statistics applied to clinical research.
• Ability to interpret and integrate preclinical, translational, and clinical data into clinical trial design and development planning.

Apply online using the form below. Only applications matching the job profile will be considered.