Purpose:

Responsible for ensuring team contributes to delivering practical and clinically meaningful data strategy and information on the use of AbbVie's marketed products and assets in development across 2 or more therapeutic teams. The TA Head will lead teams to contribute strategically and support cross-functional brand and/or asset teams, and other governance teams. Define current and unmet medical needs for therapeutic area. Understand treatment and diagnosis algorithms across geographies. Give advice on evolving standards of care to identify where unmet needs exist today and where they may exist in the future. Consider how data needs vary across geographic markets and propose phase 3b/4 studies.

Responsibilities:

• Provides specialist medical strategic and operational input into core medical affairs activities such as health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives; safeguarding patient safety. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies and to support medical/marketing activities and market access.
• Supervises 2 or more teams typically with multiple levels of management. Participates as a member of the GMA leadership team. Actively participates in advancing and communicating corporate and management leadership philosophies and agenda. Responsible for talent management, retention of key talent and development of multiple TA teams.
• Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports across different products.
• Develop creative and effective solutions to inter and intra priority conflicts, resource constraints and other problems which may impact the group. Drives the design and aggressive execution of a high quality development or medical affairs program supporting the therapeutic area strategy effectively and efficiently meets ethical, scientific, commercial, regulatory and quality requirements.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. Maintains an up-to-date analysis of competitor product information.
• Track progress of execution of medical development or medical affairs programs in terms of deliverables and area management. Establish and maintain multi bi-directional communication with the GPT, internal governance committees and functional area management.
• Continuously validate the viability of a project from a scientific and commercial perspective. Determine, in collaboration with the Therapeutic Area TEC, the global development strategy for late stage and marketed products and contributes to the Therapeutic Area LRP and Portfolio Planning.
• Fully responsible to supervise the project activities of the medical affairs TA team members in the accomplishment of all goals and milestones under his/her direct and matrix control. 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.
• Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Can address complex problems within discipline or across several projects. Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors.
• Accountable for the medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides strategic guidance to cross-functional team members related to the medical content. Maintains oversight of TA specific medical content included in commercial communications.

• Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Immunology (Dermatology, Rheumatology or Gastroenterology) clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required.
• 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. Advanced academic qualification is warranted.
• Typically 8 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. 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. Must have an in-depth understanding of clinical development process for Phase 1-IV or extensive knowledge of medical affairs including compliance and regulatory requirements.
• Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives. Experience in budgeting and administering departmental and project expenses.
• Works independently and leads team.
• 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.