Associate Medical Director - Clinical Development, Immunology

Role Summary

Associate Medical Director, Clinical Development – Immunology. Lead the execution of complex clinical trials within the Immunology Therapeutic Area, shaping clinical development strategy and bridging research and clinical operations to advance treatments in lupus and autoimmune diseases.

Responsibilities

• Report directly to the Executive Director, Clinical Development Immunology, overseeing the clinical development activities within Immunology.
• Collaborate with the Research Unit to facilitate progression of 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 clinical trials.
• Serve as a clinical science expert for study teams, CROs, and study sites.
• Engage in cross-functional clinical study team meetings, providing 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 specialization in rheumatology, dermatology, or immunology.
• Minimum of three (3) years of clinical research experience in academic or industry settings, across phases I‚ÄìIV, including planning, execution, reporting, and publication.
• Demonstrated ability to forge scientific partnerships with key internal and external stakeholders.
• Comprehensive understanding of GCP, clinical trial methodology, statistics, and regulatory/clinical development landscape.
• Established history in immunology, spanning clinical and basic research.
• Autonomy with strong cross-functional collaboration, and excellent problem-solving, conflict resolution, and analytical skills.

Skills

• Clinical development leadership
• Regulatory submissions and drug development processes
• Data analysis and interpretation of safety/efficacy data
• Stakeholder engagement and communication
• Strategic thinking and due diligence for business development

Education

• MD or equivalent medical degree (specialization as noted in Qualifications)

Additional Requirements

• Travel expectations are not specified in the description.
• Any other role-specific requirements not explicitly listed in the source are not inferred.