The Medical Director provides medical/scientific strategic and operational input into core medical affairs activities such as: advancing the pipeline, 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 clinical development, global medical affairs, and commercial teams to provide strategic medical input into core brand strategies and activities. Provide scientific and technical support for pipeline and on-market assets; deliver scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participate in relevant and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
- In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight and support for pipeline and on market assets
- Participates in design and execution of clinical trials, 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 (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
- 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.
- Assists 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.
- Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
- 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.
For the Medical Director level, the following is required:
- Neurologist or Psychiatrist (MD or non-US equivalent of MD meet requirements) Completion of residency and/or fellowship or Neurology/Psychiatry is preferred.
- Minimum of 4 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5+ 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. 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.
- Typically, does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.