The posting
Job description
About Us Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making and we take pride in our collaborative working environment! In February 2025, the European Commission approved Egetis’ Emcitate® (tiratricol) as the first and only treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome). In March 2026, the U.S. FDA accepted the filing of Egetis’ New Drug Application (NDA) for Emcitate® (tiratricol) for the treatment of MCT8 deficiency and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2026. As a courageous, committed, and collaborative organization, we are seeking to grow our team to drive success both in the pre-launch and post launch phases. For more information, please visit our website at www.egetis.com or follow us on LinkedIn and Facebook
Our Values Courageous - Challenge the status quo for the benefit of the patient Committed - Operate with high ethical standards through an efficient organization to deliver top quality results Collaborative - Through trust, work seamlessly across functions and with external partners
Purpose of the role 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.
Egetis headquarters is in Stockholm, Sweden, and we welcome applications from candidates based anywhere within the Central European timezone (CET/CEST) with no relocation required. Stockholm-based or near-by area applicants are equally welcome to work from our office.
Qualifications and experience
- 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.
Key competencies
- 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.
Duties and Responsibilities
Clinical strategy and study design
- 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.
Medical oversight of study conduct
- 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.
Participant safety and pharmacovigilance
- 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.
Data review, analysis and interpretation
- 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.
Scientific documentation and communication
- 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.
Regulatory, ethical and quality compliance
- 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 committees / IRBs, and support inspection readiness.
- Ensure that study-level activities uphold the ethical and scientific integrity of the development program and core labeling texts.
Cross-functional collaboration and external engagement
- Partner with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and CMC to deliver the study on time, on budget, and to quality standards.
- Engage key opinion leaders, investigators, scientific advisors, and patient organizations; organize and synthesize expert and advisory-board input into study strategy.
- Provide medical oversight of CROs and specialty vendors (e.g., central labs, ECG, imaging, ePRO/eCOA) at the study level.
- Contribute to feasibility, timelines, budget, and risk management for the assigned study.
