Global Medical Affairs Leader- Gastroenterology

About AbbVie
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 .

Position Overview:

The Therapeutic Area Lead [Gastroenterology] in Global Medical Affairs will lead a team to develop and execute the Medical Affairs strategy for AbbVie assets in development and/or marketed products. They will be responsible for practical and clinically meaningful data strategy and delivery to inform clinical use and transform standard of care, aligning all internal stakeholders on evidence-based Medical Benefit-Risk and have deep understanding of the patient journey and apply insights to address unmet medical needs. In close collaboration with Clinical Development and Asset Teams will ensure that global current and future external stakeholder insights and health care practices are incorporated into the clinical development and regulatory plans. They will provide strategic medical input into core brand strategies, and to support medical marketing and market access activities.

Key Responsibilities:

• Actively participates in advancing and communicating corporate and GMA philosophy.
• Drives medical affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or medical affairs function. Ensures budgets, timelines, compliance requirements are factored into programs & scientific activities.
• Leads medical affairs activities and generation and dissemination of evidence supporting overall asset scientific and business strategy. Coordinates appropriate scientific and medical activities via interactions with internal stakeholders [including commercial, market access, HEOR, clinical development, precision medicine, regulatory, discovery, statistics] as they relate to on-going medical affairs projects.
• Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource to ensure development of scientifically accurate medical education programs, advisories, symposia and marketing materials. Maintains an up-to-date analysis of competitor product information.
• Oversees the conduct of GMA-led clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• Provides strategic input to design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to AbbVie conduct on clinical studies.
• Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. 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 therapeutic area clinical development teams.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the medical affairs lead for input to key regulatory discussions.
• May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area and represents the medical function on cross-functional integrated teams for medical affairs activities.
• Participates as a member of therapeutic area Leadership. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA Leadership. May assist in developing/mentoring junior medical affairs staff.

Qualifications

• 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.
• National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. 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.
• 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 possess excellent oral and written English communication skills.
• Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.
• Ex-Us: At least one further major international language is preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.