AbbVie Medical Director, Medical Affairs Oncology (AML) in Lake County, Illinois
The Medical Director Oncology will reside on the Hematology team and 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; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Collaborate with R&D and clinical development teams to support product development. Works closely with 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.
Key Responsibilities Include: * Develop global medical affairs plan for product life cycle management. * Responsible for timely execution of medical affairs plan within budget. * In cooperation with affiliate / regional medical teams, marketing, regulatory, clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. * Collaborate with internal stakeholders (R&D, commercial, regional medical teams) and external stakeholders (key opinion leaders, advocacy and cooperative groups). * Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders). * Represent AbbVie at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders. * Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global concepts/protocols and their reports across different products. * Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to AbbVie conduct on clinical studies. * Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. * 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. * Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identified training needs. * 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 develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. * 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 understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serves as the scientific team interface for key regulatory discussions. * Assists with the scientific review, development, approval, 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. * Ability to work independently. Can address complex problems within discipline or across several projects that require analysis of situation or in-depth evaluation of various complex factors. * Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
Basic: * 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. * Experience in oncology Hematology is highly preferred. * National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal). Completion of residency and/or fellowship is preferred. * Minimum of 5-7 years of Medical Affairs and/or research and development experience in the biotech/ pharmaceutical industry. 7 years of experience is preferred. * Must have an in-depth understanding of Medical Affairs role and process. * 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 complex clinical program independently. Good 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. * Must have an understanding of Pharmacovigilance practices for Clinical Development program. * Ability to interact externally and internally to support global business strategies. * Strong understanding of the pharmaceutical business. * Must possess excellent oral and written English communication skills. * Ex-Us: At least one further major international language is preferred. * Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory
Job Classification: Experienced
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 25 % of the Time
Req ID: 1705478
Equal Opportunity Employer Minorities/Women/Veterans/Disabled