Scientific Director / Senior Medical Director, Medical Affairs Psoriatic Disease

About the role

The Medical Affairs organization at AbbVie provides patients, healthcare providers, and payers with practical and clinically relevant information and solutions for using AbbVie's products. This role focuses on Psoriatic Disease, providing specialist medical and scientific leadership.

Responsibilities

• Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, and the Brand Plan.
• Works closely with Area and Affiliates to ensure consistent global execution of medical strategy.
• Contributes to the development of HEOR evidence strategies to support value proposition, market access, and payer engagement for the portfolio.
• Responsible as Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses.
• Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projects.
• Partners cross-functionally with Commercial, HEOR, Regulatory, Clinical Development, and Market Access teams, while maintaining accountability for compliance, patient safety, and scientific integrity.
• Plans and executes scientifically accurate marketing materials, medical education programs, Medical Advisory Boards, and scientific symposia.
• Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Interacts with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc) as they relate to on-going medical affairs projects.
• Serves as the scientific team interface for key regulatory discussions.
• Provides 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.
• Provides leadership, mentorship, and guidance to junior Medical Affairs colleagues.
• Fosters a culture of scientific excellence, integrity, and continuous learning within the Medical Affairs team.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
• Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
• Ensures all medical affairs activities are conducted in accordance with applicable industry codes, AbbVie SOPs, and global regulatory standards.

Qualifications

• Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
• Typically, 10-15 years of experience in the pharmaceutical industry or related.
• 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
• Medical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.).
• Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship preferred.
• Minimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred.
• Substantial understanding of relevant therapeutic area required. Direct subject matter expertise in psoriatic disease highly preferred.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Proven leadership skills in cross-functional global team environment.
• Ability to interact externally and internally to support global business strategy.
• Excellent oral and written English communication skills.