pThe Director, Clinical Development provides the medical and scientific leadership required to oversee the design, conduct, and interpretation of assigned clinical study(ies) within the tiratricol programs and other Egetis development projects. Acting as the study physician, the role holder serves as the primary medical point of accountability for study-level clinical strategy, participant safety, data integrity, and scientific quality, working cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, and external investigators and vendors, under the direction of the Chief Medical Officer. /ph3Duties and responsibilities /h3h3Clinical strategy and study design /h3ulliProvide medical and scientific input into the study concept, target product profile, and clinical development plan for the assigned indication. /liliAuthor or co-author the clinical sections of the study protocol, including objectives, endpoints, eligibility criteria, dosing rationale, and estimands; ensure scientific and ethical integrity of the design. /liliContribute to protocol synopses, amendments, and the design of the schedule of activities, ensuring feasibility and alignment with regulatory expectations. /liliProvide clinical input into case report form (CRF) design, edit checks, and the data management and monitoring plans. /li /ulh3Medical oversight of study conduct /h3ulliAct as the study physician / medical monitor, providing day-to-day medical guidance to sites, Clinical Operations, and the CRO throughout study conduct. /liliReview eligibility questions, protocol deviations, and dose-modification decisions; respond to investigator medical queries in a timely manner. /liliProvide medical input into monitoring strategy, site selection, investigator engagement, and study start-up activities. /liliSupport recruitment and retention through medical education of sites and development of study-specific medical guidance and FAQs. /li /ulh3Participant safety and pharmacovigilance /h3ulliServe as the medical reviewer for adverse events and serious adverse events at the study level; perform ongoing medical review of safety data in collaboration with Pharmacovigilance. /liliContribute to safety management plans, benefit-risk assessment, causality and expectedness assessment, and signal detection for the study. /liliSupport preparation of safety sections of the Investigator's Brochure, DSUR, and aggregate safety reports; contribute to Data Monitoring Committee (DMC) activities where applicable. /liliEscalate emerging safety findings to the Chief Medical Officer and the Benefit-Risk / safety governance bodies. /li /ulh3Data review, analysis and interpretation /h3ulliLead ongoing medical/clinical data review to ensure data quality, consistency, and integrity throughout the study. /liliProvide medical input into the statistical analysis plan; participate in database lock, unblinding, and interpretation of study results. /liliInterpret efficacy and safety findings in the clinical and scientific context and translate them into clear conclusions for internal and external audiences. /li /ulh3Scientific documentation and communication /h3ulliAuthor or provide senior medical review of key study documents, including the clinical study report (CSR), informed consent templates, and clinical narratives. /liliContribute clinical content to regulatory submissions (e.g., IND/IMPD, briefing books, MAA/NDA modules) and to responses to health-authority questions. /liliSupport abstracts, manuscripts, and congress presentations arising from the study, ensuring scientific accuracy and compliance with publication standards. /li /ulh3Regulatory, ethical and quality compliance /h3ulliEnsure study conduct complies with ICH-GCP, applicable regulations (FDA/EMA), the Declaration of Helsinki, and Egetis SOPs. /liliProvide medical input into interactions with regulatory authorities, ethics committees / IRBs, and support inspection readiness. /liliEnsure that study-level activities uphold the ethical and scientific integrity of the development program and core labeling texts. /li /ulh3Cross-functional collaboration and external engagement /h3ulliPartner with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and CMC to deliver the study on time, on budget, and to quality standards. /liliEngage key opinion leaders, investigators, scientific advisors, and patient organizations; organize and synthesize expert and advisory-board input into study strategy. /liliProvide medical oversight of CROs and specialty vendors (e.g., central labs, ECG, imaging, ePRO/eCOA) at the study level. /liliContribute to feasibility, timelines, budget, and risk management for the assigned study. /li /ulh3Qualifications and experience /h3ulliMedical degree (MD or equivalent); specialist training and/or clinical practice experience desirable (e.g., endocrinology, pediatrics, internal medicine, or a relevant rare-disease field). /liliMinimum 5 years experience as a study physician / medical monitor in biopharmaceutical clinical development. Experience in interventional clinical trials, ideally including late-stage development). /liliWorking knowledge of ICH-GCP, global regulatory requirements (FDA/EMA/ICH), pharmacovigilance principles, and clinical trial methodology, including estimands and endpoint selection. /liliExperience in protocol authoring, medical data review, safety review, and CSR/regulatory document preparation. /liliRare-disease and/or endocrinology experience an advantage; familiarity with pediatric development is desirable. /liliStrong clinical and scientific judgment, with rigorous attention to accuracy and data integrity. /liliExcellent written and verbal communication; able to translate complex clinical data for expert and non-expert audiences. /liliCollaborative, cross-functional mindset with the ability to influence without direct authority. /liliSound decision-making under uncertainty, with a patient-safety-first orientation. /liliWell organized and able to manage multiple priorities in a fast-paced, growing organization. /liliHands-on and pragmatic, with the flexibility to contribute beyond defined role boundaries as organizational needs evolve. /li /ul #J-18808-Ljbffr
Director Clinical Development
