Medical Director, Clinical Development - Immunology

Role Summary

Medical Director, Clinical Development - Immunology: Oversees the direction, planning, execution, and interpretation of clinical trials or research activities within one or more clinical development programs, collaborating with cross-functional teams to generate and interpret high-quality clinical data to support product strategy.

Responsibilities

• Manages design and implementation of one or more clinical development programs in support of the Product Development Plan; oversees education of investigators, study site personnel, and AbbVie study staff.
• Oversees clinical studies, monitors study integrity, and interprets and communicates data on safety and efficacy; manages enrollment and timelines; assesses and reports serious adverse events per policy.
• Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other documents.
• May oversee Associate Medical/Scientific Directors and Clinical Scientists.
• Provides in-house clinical expertise, coordinates activities with internal stakeholders, participates in due diligence or business development, and contributes to translational strategy as needed.
• May chair or serve on Clinical Strategy Team, developing a cross-functionally aligned Clinical Development Plan and supervising matrix team members as needed.
• Engages with opinion leaders related to the molecule and disease area; partners with Medical Affairs, Commercial, and other functions to ensure broad cross-functional input.
• Maintains up-to-date knowledge through conferences and literature to augment therapeutic-area expertise.
• Ensures understanding of regulatory requirements and compliance in global drug development; serves as clinical representative in regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards in research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
• At least 2 years of clinical trial experience in pharma, academia, or equivalent.
• Ability to run a clinical research program of moderate complexity with minimal supervision.
• Ability to lead and collaborate on a cross-functional global team.
• Ability to interact externally and internally to support global scientific and business strategy.
• Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in developing clinical strategy and study design.
• Excellent oral and written English communication skills.

Skills

• Clinical trial design and oversight
• Regulatory submission preparation
• Cross-functional leadership
• Data interpretation and scientific communication
• Translational strategy processes

Education

• Medical degree (MD or DO) or non-US equivalent; residency completed; subspecialty fellowship desirable.