Senior Medical Director, Dermatology

Role Summary

Senior Medical Director, Dermatology role leading global clinical development and strategic activities within immunology/dermatology portfolios. Focus on designing, executing, and accelerating Phase 2/3 programs, and providing clinical leadership across cross-functional teams.

Responsibilities

• Design and implement comprehensive global clinical development plans as the Clinical Lead on cross-functional teams, ensuring integration of scientific rigor and innovation.
• Develop and execute strategies to expedite development cycles, focusing on Phase 2 and Phase 3 program design and execution.
• Act as a clinical leader, engaging with academic advisors, principal investigators, patient groups, regulatory authorities, and industry collaborators.
• Utilize specialized knowledge in immunology and dermatology to support and enhance the clinical portfolio.
• Collaborate with regulatory leaders to develop and execute submission strategies, overseeing the creation and quality of clinical content for protocols, INDs, and regulatory reports, and ensuring high standards for all clinical documents and regulatory responses.
• Provide strategic input on next-generation targets with discovery teams and lead planning of Phase 1 clinical testing.
• Serve as Medical Monitor and sponsor representative with CROs, PIs, core laboratories, and other organizations involved in clinical trials.
• Ensure timely execution of assets and studies within the immunology and dermatology portfolio.
• Develop and implement publication strategies and contribute to key presentations.

Qualifications

• Advanced degree in medicine (M.D. or D.O. or equivalent). Dermatology training (board certified or eligible) preferred.
• Industry experience with a focus on late clinical development; strong academic backgrounds may be considered.
• Experience in inflammatory and immunological therapeutic areas; dermatology experience advantageous.
• Proven expertise in leading late-stage clinical trials, including protocol design, study start-up, team management, data analysis, and medical monitoring.
• Experience with Investigational New Drug (IND) applications; experience with New Drug Applications (NDA) a plus.
• Demonstrated capability as a clinical development representative on cross-functional drug development teams.
• In-depth knowledge of regulatory filings and interactions with health authorities.
• Thorough understanding of all phases of drug development.
• Excellent communication skills with the ability to engage a wide range of stakeholders.

Additional Requirements

• Travel expectations or physical demands are not specified as essential in the source.