AbbVie Director, Evidence Generation Medical Lead, Global Medical Affairs (Oncology) in Lake County, Illinois
Director, Evidence Generation Medical Lead, Global Medical Affairs (Oncology)
USA, Illinois, Lake County
Provides specialist and expert medical/scientific strategic and operational input into core medical affairs activities with focus on generation of quality clinical and scientific data for our oncology products. Works closely with asset and area/affiliates medical affairs leads, development, HEOR, market access, and commercial teams to provide strategic medical input into core brand data gaps and to propose and support activities to address those gaps. Develops and maintains professional and credible relationships with key opinion leaders; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training to evidence generation medical leads and study designated physicians.
Designs and initiates medical affairs research activities supporting overall product scientific and business strategy, including clinical trials and Real Word Evidence (RWE) plans for quality data generation and dissemination.
Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Oversees the quality conduct of medical affairs clinical trials in compliance with ICH-GCP guidelines, regulatory requirements, and Abbvie SOPs
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.
Able to influence in a matrixed environment and to successfully interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations/evidence solutions, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects.
Leads cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function.
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.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
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.
Supervises Study Designated Physicians and identifies and coordinates their training and development needs.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Works independently with limited guidance and can address complex problems within discipline 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.
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with Oncology Therapeutic Area experience in an academic or hospital environment.Completion of residency and/or fellowship is preferred.
National license to practice medicine in an academic or hospital environment.
Advanced expert knowledge in Oncology therapeutic area.
Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent.
Must have an in-depth understanding of the Clinical Development process for Phase I-IV with extensive knowledge of Pharmaceutical Drug Development including compliance and regulatory requirements.
Extensive knowledge of GCP and ICH guidelines, clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.Must have an understanding of Pharmacovigilance practices for Clinical Development programs.
Proven leadership skills in a cross-functional global team environment.Ability to interact externally and internally to support global medical affairs strategy.Ability to run a complex clinical program independently.
Ability to interact externally and internally to support global business strategies.
Must possess excellent oral and written English communication skills. Knowledge of additional major international languages is a plus
Equal Opportunity Employer Minorities/Women/Veterans/Disabled