Medical Director , 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 .
The Global Medical Affairs (GMA) organization provides patients, healthcare providers and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient's journey.
Primary Job Function:
- Drives the GMA input into and influences the development of strategy for one or more Immunology Pipeline assets, with focus on rheumatology indications.
- Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to the Immunology Pipeline Asset Strategy Teams (ASTs) for both early and late stage development program including leading or contributing to: comprehensive gap assessment, development of Scientific Communication Platform, development of integrated evidence plans to support launch readiness.
- Leads external stakeholder interactions (Payers, Patients, Prescribers, and Providers);
- Generates clinical and scientific data (enhancing therapeutic benefit and value)
- Drives scientific communication initiatives (both internal and external medical education, data, guidelines and value proposition);
- Ensures that safeguard of patient safety is at the forefront (risk minimization activities /safety surveillance activities).
- In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight and support for assigned Immunology Assets indications/projects.
- Works closely with Rheumatology Brand Teams, Immunology Pipeline cross-functional teams including AST, IEST, BST, and area/affiliate medical teams, to provide strategic input into core Rheumatology Pipeline Asset strategy, and to drive medical activities.
- Provides scientific and technical support for assigned Immunology Assets; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Asset, Development and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with the strategies for assigned Immunology Asset;
- Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training to internal teams globally.
- Represent the medical function to the Immunology Pipeline Development and Commercial Teams.
- Provide scientific and technical input to inform the development of Immunology Assets Target Product Profile (TPP).
- Provide input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP.
- Work cross functionally to lead the development of the asset Phase 3b/4 strategy
- Review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to Abbvie conduct on clinical studies.
- 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.
- Initiate medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- Lead the development and execution of advisory boards, immunology scientific booths (in collaboration with Clinical Development and Clinical Operations) and medical education programs.
- 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 Rheumatology and specific therapeutic area resource.
- May lead cross functional sub teams responsible for discrete projects within the specific therapeutic area (data analysis, expert engagement, individual publications, study collaborations...)
- Initiate research projects and drive them to completion, resulting in high quality publications.
- Lead the development and execution on internal training activities related with the Rheumatology Pipeline.
- Represent Medical Affairs in due diligence activities for the acquisition of assets aligned with the Rheumatology pipeline Strategy.
- Ensure budgets, timelines, compliance requirements are factored into programs' scientific activities.
Basics: Hire will be at Associate Medical Director level.
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements).
- Completion of residency and/or fellowship in Rheumatology.
- Minimum of 5 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. Experience in Systemic Lupus Erythematosus, Scleroderma and/or Sjogren's Syndrome is preferred.
- Ability to interact externally and internally to support global business strategy.
- Proven ability to run a clinical study or medical affairs cross-functional 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
Significant Work Activities
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 25 % 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.