Full-Time Medical Director, Clinical Development

We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on 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 the development of our novel therapeutic candidates in late-stage studies.

What You Will Do

1. Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
2. Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
3. Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
4. Draft and coordinate completion of clinical study reports
5. Prepare responses to questions from Ethics Committees and Health Authorities
6. Support integrated document development for marketing authorization filing
7. Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
8. Support preparation for FDA Advisory Committee and EU Oral Explanation
9. Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
10. Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
11. Ensure compliance with regulatory requirements and guidelines
12. Collaborate with cross-functional teams
13. Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
14. Represent externally at scientific conferences, investor meetings, and other industry events

Who You Are

• You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams.
• You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.

Minimum Qualifications

• MD or equivalent degree, with board certification in nephrology, immunology, or similar field.
• Minimum of 3+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development.
• Experience in late-stage drug development, with a preference for experience in nephrology and/or immuno-inflammatory indications
• Strong knowledge of clinical trial design and execution, including experience with adaptive trial designs and biomarker-based approaches
• Deep understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies
• Excellent communication skills, with the ability to effectively communicate complex medical and scientific information to diverse audiences
• Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach
• Ability to travel domestically and internationally, approximately 10-20% of the time.

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