Associate Medical Director/ Medical Director , US Medical Affairs - Gastro-Immunology

The Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); 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. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.

Responsibilities

• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
• 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.
• Assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
• Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• 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 therapeutic area resource.
• Ensures budgets, timelines, compliance requirements are factored into scientific activities.
• Can address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.

Hire will be at Medical Director or Associate Medical Director level based on candidate experience and qualifications.  The level will be determined through assessment of experience and education. 

For the Medical Director level, the following is required:

• Medical Doctorate (M.D.), PhD degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements).
• Completion of residency and/or fellowship or Immunology or related field  is preferred.
• Minimum of 4 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.
• Typically, does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.

For the 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.
• 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.

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.