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, participating in cross-functional teams to generate, deliver, and interpret high-quality clinical data to support product scientific and business strategy.

Responsibilities

• Manages the 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.
• Maintains overall oversight of clinical studies, study integrity, and interpretation of data related to safety and efficacy; oversees study enrollment and timelines; reports serious adverse events per policy and regulations.
• Responsible for design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May oversee work of Associate Medical/Scientific Directors and Clinical Scientists.
• Provides in-house clinical expertise for the molecule and disease, coordinates 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 (CST) and serve as Clinical Research representative to Asset Development Team (ADT) or ALB; supervises matrix team members if CST Chair.
• Acts as a clinical interface to solicit opinions from key opinion leaders; collaborates with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into Clinical Development Plans and protocols.
• Stays current with professional information and technology 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 in research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent; residency strongly preferred; subspecialty fellowship desirable.
• Medical Director: at least 2 years of clinical trial experience in pharma, academia, or equivalent.
• 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 developing clinical strategy and study protocol design.
• Excellent oral and written English communication skills.
• Ability to interact with external and internal stakeholders to support global scientific and business strategy.

Skills

• Cross-functional collaboration
• Clinical development planning
• Regulatory and compliance knowledge
• Data interpretation and scientific reporting
• Leadership and matrix team management
• Keen communication and stakeholder engagement

Education

• Medical degree required (M.D. or D.O.); residency completed; subspecialty fellowship desirable.