Beschreibung

Are you an experienced clinical development professional looking for the 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 play a central part in translating scientific insight into high-quality clinical evidence and development decisions that can make a meaningful difference for patients. You will work closely with Clinical Operations, Regulatory Affairs, Drug Safety, Biostatistics and other cross-functional partners to ensure that the clinical program is scientifically robust, operationally feasible and aligned with the compound’s development objectives. This is an opportunity to combine scientific depth with visible cross-functional leadership in an entrepreneurial, collaborative and fast-moving environment. Key Responsibilities The Clinical Development Lead is the expert responsible for leading the delivery of clinical program objectives for an assigned compound, in line with Company strategy and agreed development plans. Main responsibilities include: •Lead the Clinical Team at project level and provide clear scientific direction, alignment and guidance across the clinical program; may include line management responsibility. •Lead 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 close 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, Drug Safety Update Reports and other safety documentation, in collaboration 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 PhD, PharmD, MD, MSc or equivalent. •At least seven years of relevant experience in clinical development within the pharmaceutical or biotechnology industry. •Proven experience 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 substantial clinical development workstreams through to completion. •Strong experience in the preparation of clinical and regulatory documentation, including Investigator’s Brochures, protocols, briefing books, clinical study reports, submission dossiers and responses to Health Authorities. •Experience supporting regulatory submissions, such as INDs, NDAs and MAAs, and 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 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.