A fractional CMO role guiding clinical strategy and medical oversight for EPRA-0322, a biologic targeting anemia in chronic kidney disease, across development, regulatory, and medical affairs functions.
EPOK Therapeutics is seeking a fractional Chief Medical Officer to lead clinical strategy for EPRA-0322, its lead biologic candidate for anemia associated with chronic kidney disease. The CMO will provide medical leadership across study design, endpoint selection, and safety assessments, while ensuring clinical activities align with broader corporate and regulatory strategy.
The role also encompasses medical affairs, including scientific communication, evidence generation, and engagement with key opinion leaders and clinical partners. This is a flexible, part-time arrangement suited to an experienced physician-executive with a background in hematology, nephrology, or a related therapeutic area and prior biotech or pharmaceutical clinical leadership.
- Lead clinical development planning and study design for EPRA-0322, including endpoint selection and protocol oversight.
- Guide safety monitoring and risk-benefit assessments throughout the development programme.
- Collaborate with research, regulatory, and commercial teams to align medical strategy with organisational goals.
- Oversee medical affairs initiatives including scientific communication and evidence generation.
- Engage with key opinion leaders, clinical investigators, and regulatory agencies on behalf of the company.
- Provide cross-functional medical leadership in a fast-paced, science-driven environment.
- MD or DO degree required; additional training in clinical research, translational medicine, or health policy is advantageous.
- Board certification and substantial experience in hematology, nephrology, or a related therapeutic area.
- Prior clinical leadership experience in biotechnology or pharmaceutical development, spanning early- and late-stage programmes.
- Strong understanding of regulatory requirements for biologics and antibody-based therapeutics, including direct agency interaction experience.
- Demonstrated ability to develop and execute clinical development plans aligned to corporate strategy.
- Excellent communication and cross-functional collaboration skills.
EPOK Therapeutics is a biotechnology company developing engineered diabodies and antibody conjugates designed to precisely activate or inhibit targeted mechanisms in specific tissues and cells. The company focuses on serious hematologic and metabolic conditions, including anemia and phosphate wasting disorders, with a commitment to rigorous translational research and innovative therapeutic design.
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