Clinical Lead / Clinical Lead

Clinical Development Lead

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

In this role, you will be pivotal in translating scientific insight into high-quality clinical evidence and development decisions that can create a meaningful impact for patients. Collaborating closely with Clinical Operations, Regulatory Affairs, Drug Safety, Biostatistics, and other cross-functional partners, you will ensure that the clinical program is scientifically robust, operationally feasible, and aligned with the compound’s development objectives. This is a fantastic opportunity to blend scientific acumen with visible cross-functional leadership in an entrepreneurial, collaborative, and fast-paced environment.

Key Responsibilities

The Clinical Development Lead will be the expert responsible for steering the delivery of clinical program objectives for an assigned compound, in alignment with Company strategy and agreed development plans.

• Lead the Clinical Team at the project level, providing clear scientific direction, alignment, and guidance across the clinical program; may include 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 communications with Health Authorities.
• Drive the clinical aspects 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 assessing and communicating the compound’s benefit-risk profile.
• Support the preparation of safety-related documents, including Periodic Safety Update Reports, Drug Safety Update Reports, and other safety documentation in collaboration with the Project Physician and Drug Safety Physician.
• Maintain a comprehensive 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 PhD, PharmD, MD, MSc, or equivalent.
• At least seven years of relevant experience in clinical development within the pharmaceutical or biotechnology industry.
• Proven track record contributing to the planning, execution, reporting, and publication of Phase II to IV clinical trials in a global, cross-functional, and matrix environment.
• Demonstrated experience leading clinical projects or significant clinical development workstreams through to completion.
• Strong expertise in preparing clinical and regulatory documentation, including Investigator’s Brochures, protocols, briefing books, clinical study reports, submission dossiers, and responses to Health Authorities.
• Experience in supporting regulatory submissions, such as INDs, NDAs, and MAAs, as well as contributing to interactions with Health Authorities, including pre-IND, pre-NDA, end-of-Phase II, and SAWP/CHMP meetings.
• Excellent understanding of global drug development, from first-in-human studies to post-approval activities.
• Strong knowledge of clinical trial design methodology and statistics as 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. Please note that only applications matching the job profile will be considered.