Medical Director or Senior Scientific Director- Medical Affairs, Global Oncology Pipeline

1 month ago

Lake Forest IL, United States AbbVie, Inc Full time

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Provides specialist medical/scientific strategic and operational leadership into global oncology pipeline related medical affairs activities including but not limited to; medical and scientific strategies for the therapeutic franchise and/or multiple assets/indications, deep therapeutic area and treatment data and insights synthesis, external expert and provider interactions, generation of clinical and scientific data (enhancing therapeutic benefit, unmet medical need and added value to standards of care for patients); internal and external educational initiatives (medical education, data, guidelines and scientific communications and training). Develops and maintains professional relationships with External Experts, develops innovative research concepts aligned to evidence gaps for clinical data generation. Works cross functionally within the pipeline commercialization matrix to provide strategic medical and scientific leadership and partnership into asset strategies. Operates in alignment with AbbVie's business code of conduct, policies and all applicable laws and regulations.
Leads a team of 3-4 global pipeline scientific/ medical directors.
* Leads and partners on the development of multiple oncology asset strategies within the pipeline and strategic governance frameworks.
* Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline scientific strategy.
* Builds and shapes the Pipeline Scientific Communication Strategy for multiple assets.
* Provide scientific and technical support for assigned products; deliver scientific presentations; 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, commercial, 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 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.
* May act as scientific leader for several programs within an area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert.
* Develop scientifically accurate 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.
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Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
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 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.
* 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.
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Medical Director
* Medical Doctorate (M.Relevant therapeutic specialty in an academic or hospital environment preferred.
* 3+ years of experience in the pharmaceutical industry or equivalent
* Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent, with Global Medical Affairs experience highly preferred.
* Preferred 3-5 years of people management experience
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Senior Scientific Director
* Advanced Degree PhD or PharmD. 10+ years of experience in the pharmaceutical industry or equivalent.
* Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent, with Global Medical Affairs experience highly preferred.
* Preferred 3-5 years of people management experience
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