Medical Director, Medical Affairs

Summary

Join AbbVie and contribute your medical and scientific expertise to advance our innovative medicines and solutions. This role involves strategic and operational input into core medical affairs activities, including healthcare professional interactions, data generation, and educational initiatives. You will collaborate closely with commercial teams, providing medical input into brand strategies and supporting marketing efforts. Responsibilities encompass initiating medical affairs activities, overseeing clinical trials, and ensuring scientific accuracy in various communications. The position requires a medical doctorate or advanced degree with relevant experience in clinical trials or medical affairs. AbbVie offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k).

Requirements

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D)
• Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
• Ability to run a clinical study independently with little supervision
• Proven leadership skills in a cross-functional global team environment
• Ability to interact externally and internally to support global business strategy
• Must possess excellent oral and written English communication skills
• Advanced Degree PhD or PharmD
• Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required
• Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
• Ability to run a clinical study independently with little supervision
• Proven leadership skills in a cross-functional global team environment
• Must possess excellent oral and written English communication skills

Responsibilities

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy
• Responsible from Global Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
• Participation in design and execution of clinical trial safety, product safety and risk management plans
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia
• Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
• May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions
• Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

Preferred Qualifications

• Relevant therapeutic specialty in an academic or hospital environment preferred
• Completion of residency and/or fellowship is preferred
• 3+ years of experience is preferred
• Additional post doctorate experience highly preferred
• 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred
• 4+ years of experience is preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs