Medical Director/Senior Medical Director, Clinical Development - Specialty

Role Summary

Medical Director/Senior Medical Director, Clinical Development - Specialty oversees the direction, planning, execution, and interpretation of clinical trials or research activities within one or more clinical development programs, and participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data to support the product's scientific and business strategy.

Responsibilities

• Manages design and implementation of one or more clinical development programs in support of an overall Product Development Plan, including education of investigators, study site personnel, and AbbVie study staff.
• Oversees clinical studies, monitors study integrity, and reviews and communicates data on safety and efficacy; manages enrollment and timelines for key deliverables; assesses and reports serious adverse events per policy and regulations.
• Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
• Oversees work of Associate Medical/Scientific Directors and Clinical Scientists on related programs.
• Provides in-house clinical expertise for the molecule and disease, coordinates scientific activities with internal stakeholders, and may participate in due diligence or business development; contributes to translational strategies with Discovery colleagues as needed.
• May chair or participate in Clinical Strategy Team, developing a rigorous Clinical Development Plan with contingencies; may supervise matrix team members and serve as Clinical Research representative to Asset Development Team.
• Engages with opinion leaders and partners with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into Clinical Development Plans and protocols.
• Stays current with literature and training to augment therapeutic-area expertise.
• Understands regulatory requirements for clinical studies and global drug development; serves as clinical representative in regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
• For Medical Director: at least 2 years of clinical trial experience in industry, academia, or equivalent.
• For Senior Medical Director: at least 5 years (7 years preferred) of clinical trial experience; ability to run a complex clinical research program independently; proven leadership and ability to lead through influence.
• Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in development of clinical strategy and study protocols.
• Excellent oral and written English communication skills.
• Ability to interact with external/internal stakeholders to support global scientific and business strategy.

Skills

• Cross-functional leadership
• Clinical development planning
• Regulatory strategy and submissions
• Protocol development and data interpretation
• Medical affairs collaboration
• Translational strategy and due diligence

Education

• Medical degree (M.D. or D.O.) or non-US equivalent; residency completed; subspecialty fellowship desirable.