Senior Medical Director, Medical Affairs - Global Dermatology

Role Summary

The Senior Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for the global Dermatology portfolio, including health-care professional interactions, generation of clinical and scientific data, educational initiatives, and safeguarding patient safety. The role works closely with commercial teams to provide strategic medical input into brand strategies, and to support medical affairs, marketing activities, and market access. Reporting to the Therapeutic Area Lead for Dermatology New Indications, the position collaborates with research and development, commercial, and affiliate teams to evolve core medical, brand, and value-and-access strategies. This position is based at our Mettawa, IL location (headquarters) and follows a hybrid schedule of Tuesdays–Thursdays in the office.

Responsibilities

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
• Responsible from 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 (AEs & SAEs) 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. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AEs) and Serious Adverse Events (SAEs) if assigned to AbbVie conduct on clinical studies.
• 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.
• Provides scientific/medical education to investigators, clinical monitors, and 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.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.

Qualifications

• Medical Doctorate (M.D.) degree 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 is preferred.
• Minimum of 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.
• 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.