Medical Director, Clinical Development - Immunology
Position Overview
We are partnering with a confidential biopharmaceutical company to identify a Medical Director, Clinical Development, to support the advancement of its immunology pipeline. This is an opportunity to join an innovative clinical development organization with a strong focus on advancing therapies for patients with immune-mediated diseases.
The Medical Director will contribute to clinical development strategy and execution, providing medical and scientific expertise throughout the clinical development process. This individual will work cross-functionally to advance clinical programs, support evidence generation, and help translate emerging clinical data into development decisions.
Key Responsibilities
- Contribute to clinical development strategy and the advancement of immunology programs.
- Support the design, planning, execution, and interpretation of clinical trials across relevant stages of development.
- Perform medical monitoring and provide ongoing medical oversight of clinical trials, including review of patient safety data, adverse events, eligibility criteria, and emerging clinical findings.
- Evaluate clinical and safety data to identify potential safety signals, assess patient-level medical issues, and inform appropriate clinical management and study decisions.
- Collaborate with Clinical Operations and Pharmacovigilance to address medical queries, assess safety concerns, and support risk management throughout clinical development.
- Provide medical and scientific input into clinical study protocols, clinical development plans, and related study documentation.
- Review and interpret clinical data to inform program strategy, assess emerging findings, and guide development decisions.
- Collaborate cross-functionally with Regulatory Affairs, Translational Medicine, Biostatistics, Clinical Operations, and other key stakeholders.
- Support the preparation and review of clinical study reports, regulatory submissions, scientific presentations, and publications.
- Build and maintain relationships with clinical investigators, key opinion leaders, and external scientific experts.
Qualifications
- MD, DO, or equivalent medical degree.
- Clinical development experience within the biotechnology or pharmaceutical industry.
- Hands-on medical monitoring experience, including medical review of clinical trial data and patient safety assessments.
- Background in immunology and/or clinical development in relevant immune-mediated diseases.
- Experience contributing to clinical trial design, execution, and data interpretation.
- Understanding of clinical development principles, regulatory requirements, and drug development processes.
- Ability to work cross-functionally and translate scientific and clinical insights into development strategy.
- Strong communication, analytical, and collaboration skills.
The Opportunity
This is an opportunity to join a biopharmaceutical organization advancing a broad immunology pipeline, contribute to the development of innovative therapies, and collaborate with multidisciplinary teams to progress clinical programs with the potential to make a meaningful difference for patients.