Area TA Lead, Rheumatology
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Title: Therapeutic Area – Area Lead II
Provides medical/scientific strategic and operational input into medical affairs plans and activities, representing the Area/affiliates in coordination with the Global team. Within the Area, serves as Therapeutic Area expert in providing relevant scientific and technical training to Area and Affiliate Therapeutic Area resources. Represents the Area in key core Medical Affairs activities, such as: health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives.. Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders and professional societies; provides therapeutic expertise in interactions with regulators and other external groups; develops innovative research concepts for clinical data generation and communication.
- 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 Medial Affairs strategy.
- Provides technical expertise on the generation of hypothesizes 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.
- 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.
- Develops and executes 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, compliance requirements are factored into programs' and initiatives.
- 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 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 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 complex medical affairs team(s) independently. 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.
- Must be able to communicate effectively in oral and written English. Must have overall superior communication skills. Ex-Us: At least one major international language, besides English, is preferred.
Critical Success Factors:
- Strong leadership skills; seen as senior leader within Area.
- Ability to influence without authority
- Works independently
- 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
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 50 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.