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.
- Works together with the Rheumatology Global Medical Lead for upadacitinib to deliver GMA activities enabling the launch and on market support of upadacitinib in RA.
- Drives and influences the GMA input into the launch and on-market strategy of late stage assets, with primary focus on upadacitinib in rheumatoid arthritis (RA).
- Provides specialist medical/scientific insights, and executes on data generation, communication, and expert engagement activities as deliverables to the Asset Development Teams (ADTs) late stage development program, including leading or contributing to: comprehensive gap assessment, development of Scientific Communication Platform, and development of total evidence plans to support upadacitinib launch readiness.
- May lead 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 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 upadacitinib in RA.
- Works closely with Global Medical and Brand Teams, cross-functional teams including ADT, CST, GCT, and area/affiliate medical teams, to provide strategic input into upadacitinib launch strategy, and to drives medical activities.
- Provides scientific and technical support for upadacitinib in RA; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Development and Commercial cross-functional teams and drives the development of medical affairs objectives aligned with the strategies for assigned asset;
- Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training to internal teams globally.
- Works cross functionally to develop the integrated evidence plan including 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.
- Initiate medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- May lead the development and execution of advisory boards, immunology scientific booths (in collaboration with Clinical Development and Clinical Operations) and medical education programs.
- 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 Immunology 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.
- May lead the development and execution on internal training activities related to upadacitinib in rheumatology.
- If required, represent Medical Affairs in due diligence activities for the acquisition of assets aligned with the rheumatology strategy.
- Ensure budgets, timelines, compliance requirements are factored into programs' scientific activities.
Hire will be at Medical Director or Sr. Medical Director level based on candidate experience and qualifications. The level will be determined through assessment of experience and education.
Medical Director requirements:
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- 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 clinical study or medical affairs team independently with little supervision
- 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.
- 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, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
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.
Esperienze professionali significative: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Tipo di contratto: Experienced