Clinical Development Lead

Job description

The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Are you an experienced clinical development professional eager to take scientific ownership of a clinical program and help shape the future of a differentiated therapy? We are seeking 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 role in translating scientific insight into high-quality clinical evidence and development decisions that can make a meaningful difference for patients. This role offers the opportunity to shape lifecycle evidence generation and unlock the full potential of differentiated medicines through clinically meaningful, scientifically robust and strategically aligned development activities. Working closely with Clinical Operations, Regulatory Affairs, Drug Safety, Biostatistics, Medical Affairs and Commercial colleagues, you will ensure development plans are scientifically robust, operationally feasible and strategically aligned. 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 clinical and scientific 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 multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment and accountability across the program. Shape innovative clinical development strategies that maximize the compound's value throughout its lifecycle, integrating emerging scientific evidence and evolving standard of care into development plans. 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. Provide thought leadership in clinical trial design and execution in close partnership with key functions, ensuring scientific quality, clear prioritisation 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 Company as a credible scientific leader externally with investigators, scientific experts, advisory boards and Health Authorities. Champion the clinical perspective in cross-functional discussions and support the continuous evolution of the clinical development strategy. Candidate Requirements Advanced degree in life or health sciences, such as PhD, MD, PharmD, MSc or equivalent. At least eight years of relevant experience in clinical development within the pharmaceutical or biotechnology industry. Proven experience leading Phase II to IV clinical development programs in global, cross-functional matrix environments through successful planning, delivery and publication. Strong experience supporting global regulatory submissions and Health Authority interactions, including the preparation of key clinical and regulatory documents throughout the development lifecycle. Excellent understanding of global drug development and innovative clinical trial design through all phases, with the ability to integrate preclinical, translational, clinical, and real-world evidence to inform development strategies; pediatric development experience is an advantage. Intellectually curious with strong scientific acumen, entrepreneurial spirit, and learning agility, with the ability to challenge conventional thinking constructively. Excellent written and verbal communication skills, with strong executive presence and the ability to effectively communicate complex scientific concepts to diverse internal and external stakeholders Strong project management, prioritization, problem-solving and stakeholder-management capabilities. Ability to work independently, influence decision-making and build alignment across cross-functional teams in a dynamic matrix organization. A collaborative, proactive and pragmatic mindset, with a strong sense of ownership and commitment to delivering high-quality clinical evidence. Work Location: Allschwil, Switzerland (primarily on-site) Business Area: Global Clinical Development Job Type: Permanent, full time Job ID : 4806 At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success. We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees. Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course. Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.