AbbVie Scientific/Medical Director, US Medical Affairs Immunology - SpA in Lake County, Illinois
Scientific/Medical Director, US Medical Affairs Immunology - SpA
USA, Illinois, Lake County
Research & Development
The Medical Director in Medical Affairs will provide specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). In addition, the Medical Director works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and supports medical/marketing activities (promotional material generation/product launches) and market access. Lastly, he/she will provide scientific and technical support for assigned products; deliver scientific presentations; develop and maintain professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy
• Participation in design and execution of clinical trial safety, product safety and risk management plans
• May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
• 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
• All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
• May interact with and coordinates 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
• 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
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements
• Serves as the scientific team interface for key regulatory discussions
• 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
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
• Can address complex problems within discipline/project or across disciplines
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors
• Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
Non MD will be considered at the Scientific Director hierarchy, Advanced degree highly preferred.
Rheumatology/Immunology therapeutic expertise highly preferred.
Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred. Proven leadership skills in a cross-functional global team environment
Ability to interact externally and internally to support global business strategy
Ability to run a clinical study or medical affairs team independently with little supervision
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
Expert knowledge in a relevant therapeutic specialty. Ability to interact externally and internally to support global business strategy
Must possess excellent oral and written English communication skills
Ex-Us: At least one further major international language is preferred