Director, Clinical Development

This is a fully remote position, open to applicants in Sweden.

📋 Description

• Provide medical and scientific insights into the study concept, target product profile, and clinical development strategy for the designated indication.

• Author or co-author clinical sections of study protocols, encompassing objectives, endpoints, eligibility criteria, dosing rationale, and estimands.

• Contribute to protocol synopses, amendments, schedules of activities, CRF design, edit checks, data management plans, and monitoring plans.

• Serve as the study physician/medical monitor, offering daily medical guidance to sites, Clinical Operations, and CROs.

• Review eligibility inquiries, protocol deviations, dose modification decisions, and investigator medical queries.

• Provide medical insights into monitoring strategies, site selection, investigator engagement, and study initiation.

• Support recruitment and retention efforts through site medical education and study-specific medical guidance.

• Review adverse events and serious adverse events, continuously assess safety data in conjunction with Pharmacovigilance.

• Contribute to safety management plans, benefit-risk evaluations, causality and expectedness analyses, signal detection, and safety reporting.

• Assist in the preparation of Investigator’s Brochure, DSUR, aggregate safety reports, and Data Monitoring Committee activities.

• Report emerging safety findings to the Chief Medical Officer and relevant safety governance bodies.

• Lead ongoing medical/clinical data assessments and provide input into the statistical analysis plan.

• Participate in database locking, unblinding, and interpreting study results.

• Analyze efficacy and safety data and communicate findings to both internal and external stakeholders.

• Author or conduct senior medical reviews of CSRs, informed consent templates, clinical narratives, regulatory submissions, abstracts, manuscripts, and presentations at congresses.

• Ensure adherence to ICH-GCP, FDA/EMA regulations, the Declaration of Helsinki, and Egetis SOPs.

• Facilitate interactions with regulatory authorities, ethics committees/IRBs, and ensure inspection readiness.

• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and CMC.

• Engage with key opinion leaders, investigators, scientific advisors, and patient organizations.

• Provide medical oversight of CROs and specialized vendors.

• Contribute to feasibility assessments, timelines, budgeting, and risk management for the assigned study.

⛳️ Requirements

• Medical degree (MD or equivalent); specialist training and/or clinical practice experience is preferred (e.g., endocrinology, pediatrics, internal medicine, or a relevant rare-disease field).

• At least 5 years of experience as a study physician/medical monitor in biopharmaceutical clinical development.

• Experience in interventional clinical trials, preferably including late-stage development.

• Proficient understanding of ICH-GCP, global regulatory requirements (FDA/EMA/ICH), pharmacovigilance principles, and clinical trial methodologies, including estimands and endpoint selection.

• Experience in protocol writing, medical data review, safety evaluation, and CSR/regulatory document preparation.

• Experience in rare diseases and/or endocrinology is a plus.

• Familiarity with pediatric development is desirable.

• Strong clinical and scientific judgment, with meticulous attention to accuracy and data integrity.

• Exceptional written and verbal communication skills; capable of translating complex clinical data for both expert and lay audiences.

• Collaborative and cross-functional approach with the ability to influence without direct authority.

• Strong decision-making abilities in uncertain situations, prioritizing patient safety.

• Highly organized and adept at managing multiple priorities in a fast-paced, growing organization.

• Hands-on and pragmatic, with the adaptability to contribute beyond defined role boundaries as organizational needs change.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements to support work-life balance.

• Supportive and inclusive company culture.