Associate Scientific/Medical Director, Global Medical Affairs - Migraine

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.

This role provides medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (promotional material generation/product launches) and market access.

Primary responsibilities include:

• Drives GMA input into and influences the development of strategy for Migraine assets

• Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to relevant 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 Migraine Assets indications/projects

• Works closely with Migraine Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core Migraine Asset strategy, and to drive medical activities

• Initiate medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy

• Provides scientific and technical support for assigned Migraine 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 strategy

• Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training to internal teams globally

• Represents the medical function to the Migraine Development and Commercial Teams

• Provides scientific and technical input to inform the development of Migraine Asset Target Product Profiles (TPP)

• Provides input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP

• Works cross functionally to lead the development of the asset Phase 3b/4 strategy

• Reviews, assess and reports 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

• Leads the development and execution of advisory boards, scientific and medical education programs

• Provides scientific/medical education to all relevant internal stakeholders 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 Migraine and specific therapeutic area resource

• Lead functional and cross functional 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

• Represents Medical Affairs in due diligence activities for the acquisition of assets aligned with the Disease Area Strategy

• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

For the Associate Scientific Director title, the following is required:

• An advanced degree is (PhD, PharmD, Medical Doctorate (M.D.) degree or (D.O. or non-US equivalent of M.D. meet requirements)  is required
• Completion of residency and/or fellowship in Neurology or post doctorate experience
• 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 Migraine 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

For an Associate Medical Director title, the following is required:

• 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.
• Minimal clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
• 1-2 years of experience is preferred.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• May possibly have performed protocol design in the academic environment or in the pharmaceutical industry and/or acted as an assistant PI or PI.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects/schedules, etc.
• Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
• Ex-Us: At least one further major international language is preferred.