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.
Senior Director, Scientific Medical Affairs
Lake County, IllinoisReq ID 2207870Category Research and DevelopmentDivision AbbVie
Provides specialist 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 sales, 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.
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.
In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
Establishes and approves scientific methods for hypotheses, rational, design of affiliate protocols and their reports across different products. Oversee scientific/medical education of 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.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
Lead a team of 3-4 Medical Affairs SME's.
May act as scientific leader for several programs within an area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert.
May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
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
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.
Advanced Degree PhD, PharmD, PA, NP highly preferred. Residency or additional post doctorate experience is highly preferred.
Typically 15 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
Management or leadership experience at the program level, experience with strategy development; senior staff role within a TA. Proven leadership skills in a cross-functional global team environment International experience is a plus.
Ability to interact externally and internally to support global business strategy.
Ability to run a clinical program or medical affairs team(s) independently with littler supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.
Ability to interact externally and internally to support global business strategy. Most possess excellent oral and written communication skills.
Can address 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.
Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)