Medical Director, Clinical Development, Immunology

Role Summary

Medical Director, Clinical Development – Immunology responsible for shaping and leading immunology clinical programs, with a focus on lupus and autoimmune diseases. Leads clinical development strategy and execution of complex trials, bridging research and clinical operations to ensure efficacy and safety in patient care.

Responsibilities

• Report directly to the Executive Director, Clinical Development Immunology, overseeing clinical development activities within Immunology.
• Collaborate with the Research Unit to progress projects into Phase I and PoC activities.
• Contribute to and review clinical study documents (CSPs, CSRs, IBs, PIS/ICFs, SAPs) and regulatory submissions (INDs, BBs).
• Monitor, analyze, and interpret safety and efficacy data from ongoing trials.
• Serve as a clinical science expert for study teams, CROs, and study sites.
• Participate in cross-functional clinical study team meetings and provide insights and direction.
• Develop and deliver presentations to internal teams and external stakeholders.
• Foster relationships with external and internal stakeholders and contribute to decision-making panels.
• Offer clinical scientific expertise to support business development initiatives, including due diligence.

Qualifications

• MD or equivalent medical degree, with a preference for rheumatology, dermatology, or immunology.
• Minimum of five (5) years of clinical research experience across phases I–IV in academic or industry settings.
• At least three (3) years' experience in all facets of clinical trial execution in the pharmaceutical industry (planning, execution, reporting, publication).
• Demonstrated ability to forge scientific partnerships with internal and external stakeholders.
• Comprehensive understanding of GCP, trial methodology, statistics, and regulatory and development landscape.
• Significant experience in immunology, including clinical and basic research.
• Autonomy in work, strong cross-functional collaboration, and excellent problem-solving, conflict resolution, and analytical skills.

Skills

• Clinical development leadership
• Clinical trial design and execution
• Regulatory documentation and submissions
• Data analysis and interpretation
• Cross-functional collaboration

Education

• MD or equivalent medical degree

Additional Requirements

• Experience with Phase I–IV development and immunology focus; leadership responsibilities within a Therapeutic Area.