AbbVie Associate Medical Director / Scientific Director, USMA Oncology Solid Tumors in North Chicago, Illinois
Associate Medical Director / Scientific Director, USMA Oncology Solid Tumors
USA, Illinois, Lake County
Responsible for supporting the US Medical Affairs Team (USMAT) in developing evidence generation proposals, concepts and protocols. Reviews IIS proposals and protocols and provides recommendations for appropriate study designs and testing schedules. Partners with team members, cross-functional colleagues and external collaborators to maximize the quality of evidence needed to address strategic gaps. Serves as Medical Monitor for USMA-led AbbVie-Sponsored studies. Engages with external experts in both academic and community settings to conduct scientific exchange. Individual contributor who supports all USMA Solid Tumor programs (pipeline, launch preparation and on-market).
Key Responsibilities Include:
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
Safety surveillance for pharmaceutical / biological / drug –device combined products
Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Under the guidance of PST Lead write, review and provide input on technical documents
Level commensurate to experience.
Associate Medical Director, US MA - Oncology, Solid Tumors
MD/ DO with 2+ years of residency with cancer patient management experience required
Effectively analyze clinical data and other relevant datasets.
Effectively write technical documents with directions
Work collaboratively in a team environment and be self-starting and able to work independently
Ability to effectively present recommendation/ opinions in group environment
Fluent in English, both written and oral
Scientific Director, US MA - Oncology, Solid Tumors
Advanced Degree PhD, PharmD, PA, NP highly preferred. Residency or additional post doctorate experience is highly preferred.
Typically 5-10 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
Experience with strategy development. Proven leadership skills in a cross-functional team environment 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 little 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 US business strategy.
Must possess excellent oral and written communication skills.
Ability to 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 and Conditions: N/A
Travel: Yes, 50 % of the Time
Job Type: Experienced
Job Level Code: D