Medical Director US Medical Affairs Gastroenterology
Has strategic and operational medical affairs responsibility for Humira (adalimumab) as well as GI pipeline compounds. Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains 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. Key Responsibilities Include:
- 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 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. 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.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. 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 preferred, PhD acceptable for exceptional candidates
- Relevant therapeutic specialty (Gastroenterology/Immunology) in an academic or hospital environment or in private practice. Completion of residency and/or fellowship is preferred.
- Minimum of 3 years of medical affairs/clinical trial experience in the pharmaceutical industry or equivalent.
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written English communication skills.