Associate Medical Director/Scientific Director, Clinical Development - Immunology

Role Summary

Associate Medical Director/Scientific Director, Clinical Development - Immunology. Oversees direction, planning, execution and interpretation of clinical trials or research activities within a clinical development program, contributing to cross-functional teams to generate and interpret high-quality clinical data supporting product strategy. Roles include Medical Director and Scientific Director responsibilities as part of a clinical development leadership track.

Responsibilities

• With supervision, designs and implements study protocols for a clinical development program aligned with the Product Development Plan, ensuring compliance with regulatory requirements and operational needs; oversees investigators and site personnel education.
• Oversees clinical study integrity, data interpretation, and communication of safety and efficacy findings; manages study enrollment and timelines for key deliverables; reports serious adverse events per policy.
• Contributes to design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
• May serve on an Integrated Evidence Strategy Team; collaborates to develop a rigorous Clinical Development Plan with cross-functional alignment.
• Interacts with opinion leaders and partners with Medical Affairs, Commercial, and other functions as required; stays current with professional information and training to augment therapeutic expertise.
• Ensures understanding and compliance with regulatory requirements for clinical studies and global drug development; contributes to regulatory responses as needed; ensures adherence to Good Clinical Practices and pharmacovigilance standards.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent; rheumatology specialization or lupus research experience preferred.
• Ability to run a clinical research study under supervision; strong cross-functional collaboration skills; prior clinical trial experience in pharma, academia, or equivalent preferred.
• Knowledge of clinical trial methodology, regulatory/compliance requirements, and study protocol design; ability to interact with internal and external stakeholders to support global strategy.
• Excellent oral and written English communication skills.

Skills

• Clinical trial design and oversight
• Data interpretation and regulatory submissions
• Cross-functional collaboration
• Regulatory compliance and Good Clinical Practices
• Pharmacovigilance standards

Education

• Medical degree required; advanced degrees in sciences (e.g., MS, PhD, PharmD) preferred for Scientific Director path; rheumatology research experience valued.