Director, Clinical Lead

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.Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).Are you a Clinical Project Scientist ready to take full ownership of a clinical program and make a tangible impact? We’re looking for a scientifically grounded, resource-savvy and hands-on professional to lead the design, execution, and oversight of clinical trials within a dynamic, efficiency-driven environment. At our company, smart use of resources and financial discipline go hand in hand with scientific innovation. You’ll work cross-functionally with clinical, regulatory, and operational teams to ensure that every step of the program aligns with our high standards for quality, value, and impact. If you're ready to lead with both scientific insight and operational focus, we want to hear from you.Key ResponsibilitiesThe Clinical Development Lead is the clinical/scientific expert responsible for the delivery of all clinical program deliverables as per the objectives set by the Company or Management.Main Responsibilities Leads the Clinical Team (on project level – may have direct reports) Leads the development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) Drives execution of the section of the clinical program in partnership with global line functions. Ensures ongoing clinical and scientific review of clinical trial data. Is a core member of the Safety Management Team and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with the Project Physician and Drug Safety Physician Maintains updated knowledge of competitive landscape regarding assets with similar MOA and/or evolving standards of care for indications of interest Acts as the clinical lead for study abstracts, posters, oral presentations and manuscripts of the clinical program. Candidate Requirements PhD, Pharm D, MD, MSc or equivalent university degree in life or health sciences At least 5 years of contribution to and accomplishment in all aspects of conducting phase II to IV clinical trials (e.g. planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry. Good track record of regulatory submission (IND, NDA, MAA) and interactions with Health Authorities ( pre-IND, pre-NDA, end of Phase 2, SAWP/CHMP ) Proven track record of successfully leading clinical projects through to completion Excellent understanding of global drug development from entry-into-man to post-approval activities including expert knowledge of clinical trial design methodology and statistics applied to clinical trials Understanding preclinical data and ability to integrate them in the clinical trial design and development plan Excellent written and oral communication skills, in particular scientific writing skills Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data Strong affinity with data, data quality and analysis Well-developed project management, communication, problem solving, and presentation skills Demonstrated ability to understand, influence and work independently and effectively in cross-functional teams and matrix organizations Strong planning and priority setting capabilities, ability to initiate, develop, and implement changes What Idorsia Offers Exciting opportunities for development and professional growth within our dynamic organization A collaborative and solution-oriented environment where you can make a difference An innovative and open culture in a truly multicultural environment A competitive salary and generous social benefits Work Location: Allschwil Country: Switzerland Business Area: Global Clinical Development Schedule: Fulltime Job Type: Permanent Job ID : 4662 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.