Director Clinical Development

The 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.

• Provide medical and scientific input into the study concept, target product profile, and clinical development plan for the assigned indication.
• Author 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.
• Contribute to protocol synopses, amendments, and the design of the schedule of activities, ensuring feasibility and alignment with regulatory expectations.
• Provide clinical input into case report form (CRF) design, edit checks, and the data management and monitoring plans.

• Act as the study physician / medical monitor, providing day-to-day medical guidance to sites, Clinical Operations, and the CRO throughout study conduct.
• Review eligibility questions, protocol deviations, and dose-modification decisions; respond to investigator medical queries in a timely manner.
• Provide medical input into monitoring strategy, site selection, investigator engagement, and study start-up activities.
• Support recruitment and retention through medical education of sites and development of study-specific medical guidance and FAQs.

• Serve 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.
• Contribute to safety management plans, benefit-risk assessment, causality and expectedness assessment, and signal detection for the study.
• Support preparation of safety sections of the Investigator's Brochure, DSUR, and aggregate safety reports; contribute to Data Monitoring Committee (DMC) activities where applicable.
• Escalate emerging safety findings to the Chief Medical Officer and the Benefit-Risk / safety governance bodies.

• Lead ongoing medical/clinical data review to ensure data quality, consistency, and integrity throughout the study.
• Provide medical input into the statistical analysis plan; participate in database lock, unblinding, and interpretation of study results.
• Interpret efficacy and safety findings in the clinical and scientific context and translate them into clear conclusions for internal and external audiences.

• Author or provide senior medical review of key study documents, including the clinical study report (CSR), informed consent templates, and clinical narratives.
• Contribute clinical content to regulatory submissions (e.g., IND/IMPD, briefing books, MAA/NDA modules) and to responses to health-authority questions.
• Support abstracts, manuscripts, and congress presentations arising from the study, ensuring scientific accuracy and compliance with publication standards.

• Ensure study conduct complies with ICH-GCP, applicable regulations (FDA/EMA), the Declaration of Helsinki, and Egetis SOPs.
• Provide medical input into interactions with regulatory authorities, ethics…