Major Responsibilities:

•            Serves as Therapeutic Area subject matter expert in all assigned indications including new asset launches and indications

•            Provides expert consultation to affiliates and Area Medical Head on development of the affiliate therapeutic area strategy and brings insights and knowledge from the Areas into the development of the Global Medical Affairs strategy.

•            Provides technical expertise on the generation of hypotheses to be tested, method and design of Area research, trial execution and communication.  Oversees the conduct of Area clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, safety monitoring, study reports and other communications of study results.

•            Provides technical consultation to affiliates in the development and method of evaluation of research hypotheses.

•            Understands the strategic needs of affiliates and communicates gaps to area leadership. Fosters a network across area and interacts with affiliate TA staff in a regular fashion.

•            Serves as the representative of the Area in providing input into the content of Registration and Global Medical Affairs trials

•            Educates on and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.), including training Area and Affiliate cross-functional peers on therapeutic area topics.  On-boards Affiliates and Area Cross-functional partners to TA/Product topics.

•            May develop and execute medical education programs, advisories, and symposia.

•            Oversees scientific/medical education of investigators, clinical monitors for Area Trials.  May provide support to Affiliate sponsored trials as warranted.

•            Manages and conducts area external expert engagement.  Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.

•            Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.  May serves as the scientific team representative for regulatory discussions

•            Supports affiliate Advisory Boards and conducts Area/Regional Ad Boards, including ensuring budgets, timelines, and compliance requirements are factored into programs and initiatives.

Qualifications:

Advanced degree (MD, PhD, DO) with relevant therapeutic specialty experience highly preferred.  Completion of residency and/or fellowship is desirable.  Relevant therapeutic area clinical experience in academic and/or hospital environment, and/or Medical Affairs experience in a pharma environment required.  Advanced academic qualification is warranted. Expert knowledge in relevant therapeutic area.  Professional license to practice medicine desirable.

• Typically 3 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 

• Proven leadership skills in a cross-functional global team environment.  Ability to interact externally and internally to support global business strategy.  Extensive 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.  Must have basic understanding of Pharmacovigilance practices for Clinical Development programs.  

• Ability to interact externally and internally to support global business strategies.  Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives.

• Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

• Strong communication skills. Fluent in written and spoken English.

Critical Success Factors:

• Able to work independently

• Strong leadership skills

• Ability to influence without authority 

• Can address complex problems within discipline or across several projects

• Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.

• Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

• Strong communication skills. Fluent in written and spoken English.