Director, Clinical Development

🕒 September 18

🇸🇪 Sweden – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 18%

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Egetis Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Egetis is an innovative, integrated pharmaceutical company focused on late-stage development and commercialization of treatments for serious diseases with significant unmet medical needs, particularly in the orphan drug segment. The company's lead product candidate is Emcitate (tiratricol) for MCT8 deficiency/Allan‑Herndon‑Dudley syndrome; its pipeline also includes Aladote for acetaminophen (paracetamol) overdose. Headquartered in Stockholm, Sweden, Egetis positions itself around development, regulatory interaction and market access for rare-disease therapeutics.

📋 Description

• Provide medical and scientific input into the study concept, target product profile, and clinical development plan for the assigned indication • Author or co-author clinical sections of study protocols, including objectives, endpoints, eligibility criteria, dosing rationale, and estimands • Contribute to protocol synopses, amendments, schedule of activities, CRF design, edit checks, data management plans, and monitoring plans • Act as study physician / medical monitor, providing day-to-day medical guidance to sites, Clinical Operations, and CROs • Review eligibility questions, protocol deviations, dose-modification decisions, and investigator medical queries • Provide medical input into monitoring strategy, site selection, investigator engagement, and study start-up • Support recruitment and retention through site medical education and study-specific medical guidance • Review adverse events and serious adverse events and perform ongoing medical review of safety data with Pharmacovigilance • Contribute to safety management plans, benefit-risk assessments, causality and expectedness assessments, signal detection, and safety reports • Support Investigator’s Brochure, DSUR, aggregate safety reports, and Data Monitoring Committee activities • Escalate emerging safety findings to the Chief Medical Officer and safety governance bodies • Lead ongoing medical/clinical data review and provide input into the statistical analysis plan • Participate in database lock, unblinding, and interpretation of study results • Interpret efficacy and safety findings and communicate conclusions to internal and external audiences • Author or provide senior medical review of CSRs, informed consent templates, clinical narratives, regulatory submissions, abstracts, manuscripts, and congress presentations • Ensure compliance with ICH-GCP, FDA/EMA regulations, Declaration of Helsinki, and Egetis SOPs • Support interactions with regulatory authorities, ethics committees/IRBs, and inspection readiness • Partner cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and CMC • Engage key opinion leaders, investigators, scientific advisors, and patient organizations • Provide medical oversight of CROs and specialty vendors • Contribute to feasibility, timelines, budget, and risk management for the assigned study

🎯 Requirements

• Medical degree (MD or equivalent); specialist training and/or clinical practice experience desirable (e.g., endocrinology, pediatrics, internal medicine, or a relevant rare-disease field) • Minimum 5 years experience as a study physician / medical monitor in biopharmaceutical clinical development • Experience in interventional clinical trials, ideally including late-stage development • Working knowledge of ICH-GCP, global regulatory requirements (FDA/EMA/ICH), pharmacovigilance principles, and clinical trial methodology, including estimands and endpoint selection • Experience in protocol authoring, medical data review, safety review, and CSR/regulatory document preparation • Rare-disease and/or endocrinology experience an advantage • Familiarity with pediatric development is desirable • Strong clinical and scientific judgment, with rigorous attention to accuracy and data integrity • Excellent written and verbal communication; able to translate complex clinical data for expert and non-expert audiences • Collaborative, cross-functional mindset with the ability to influence without direct authority • Sound decision-making under uncertainty, with a patient-safety-first orientation • Well organized and able to manage multiple priorities in a fast-paced, growing organization • Hands-on and pragmatic, with the flexibility to contribute beyond defined role boundaries as organizational needs evolve

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