Full-Time Medical Director, Clinical Development

We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our immunology clinical programs, specifically severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead, the MD is a key member of the clinical development team supporting novel therapeutic candidates in late-stage studies.

Responsibilities:

• Support the design and execution of clinical development plans, aligning with strategic objectives and timelines.
• Provide medical and scientific oversight for clinical trials (protocol development, study monitoring, data review, and analysis).
• Collaborate with Clinical Operations on trial setup, conduct, recruitment, closeout, and reporting.
• Draft and coordinate clinical study reports.
• Prepare responses to Ethics Committees and Health Authorities.
• Support integrated document development for marketing authorization filing.
• Interpret, report, and prepare clinical research results for health authority submissions.
• Support preparation for FDA Advisory Committee and EU Oral Explanation.
• Lead cross-functional project teams (clinical operations, biometrics, clinical pharmacology, regulatory affairs, medical writing, etc.).
• Establish and maintain relationships with key opinion leaders and clinical investigators.
• Ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams.
• Participate in due diligence activities and provide medical expertise.
• Represent externally at scientific conferences, investor meetings, etc.

Qualifications:

• MD or equivalent degree, with board certification in nephrology, immunology, or similar field.
• 3+ years of clinical development experience in the pharmaceutical or biotechnology industry.
• Late-stage drug development experience, with a preference for nephrology and/or immuno-inflammatory indications.
• Strong knowledge of clinical trial design, execution, adaptive trial designs, and biomarker-based approaches.
• Deep understanding of regulatory requirements and leading interactions with global regulatory agencies.
• Excellent communication and interpersonal skills.
• Ability to travel (10-20%).

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