AbbVie

Senior Medical Director, Global Medical Affairs, Neuroscience Pipeline

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 13, 2020
Ref
2008264
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 .

Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (scientific communication platform medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Represents Global Medical Affairs at the designated Asset Development Teams. Works closely with The Asset Development Team Leaders, Global Clinical Development, Global Commercial Development, Regulatory Affairs, HEOR and Market Access representatives in the 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.
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 asset development Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training

Key Responsibilities Include:
  • Represents Global Medical Affairs at the Asset Development Teams assigned to the role, in the areas of Alzheimer┬┤s Disease, early Parkinson┬┤s Disease and other neurodegenerative conditions.
  • Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
  • Participation in 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 (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies. Represents Global Medical Affairs at the Product Safety Teams assigned to the role.
  • Generates and maintains the Scientific Communication Platform for each asset in development in Neuroscience.
  • Drives and coordinates the generation and review of the gap analysis plan for each of the Neuroscience assets assigned to the role.
  • Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
  • 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.
  • Provide scientific/medical education to investigators, clinical monitors, Global Project Team members, and Area/affiliate Neuroscience Medical teams related to therapeutic area or disease specific information.
  • Keeps abreast of professional information and technology through conferences and/or medical literature and acts as the main therapeutic area resource for the assets assigned to the role.
  • Assists in the development of scientifically accurate marketing materials, medical education programs, advisory boards, pipeline/scientific booth materials and symposia.
  • Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
  • Contributes to the generation of the Publication Plans for the assets assigned to the role.
  • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
  • 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
  • Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Qualifications
  • Medical Doctorate (M.D.) degree or equivalent (non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship in Neurology preferred. Non MD with advance degree (PhD, PharmD or MS) can be considered in the Scientific hierarchy.
  • National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (MD or equal) is strongly preferred. Completion of residency and/or fellowship in Neurology.
  • Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry. Plus clinical or academia 7+ 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 Neurology.
  • 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.

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.