The Scientific Director, or Associate Medical Director provides medical and scientific strategic and operational input into core medical affairs activities such as: health care professional and 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 and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access.  Executes core medical affair tactics to support launch. Collaborates with clinical development on Medical Affairs support of priority trials.

Key responsibilities include:

• Contributes to the development of brand strategies.
• Lead and support Medical Affairs initiatives (strategy and tactics) for Parkinson’s Disease asset launch
• Develops and executes Medical Affairs support of priority clinical development trials
• Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan. Lead the individual (Global) Conference planning and execution.
• Generates clinical and scientific data per evidence gap assessment.
• Responsible to manage budget for assigned projects.
• May support cross-functional teams with subject matter expertise.
• Aligns Medical education and scientific initiatives with Sci Comm Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IISs.
• Actively contributes to the development of a TA EE Engagement Plan.
• Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials.
• Participates in design and execution of clinical trial safety, product safety and risk management plans. Track RMP implementation.
• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

For the Scientific Director title, the following is required: 

• Advanced Degree: MD, PhD, PharmD, PA or NP preferred. Residency or additional post doctorate experience preferred.
• Minimum 8 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• May have performed protocol design in the academic environment and/or acted as an assistant PI.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
• Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written communication skills.
• May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
• May assist as consultant and 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.
• Works with some supervision and guidance. Exercises judgment within well-defined practices and policies.

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.