Medical Director/Scientific Director, Medical Affairs

AbbVie • Mettawa, IL, United States • $200k - $250k / year • 1m ago

AbbVie Medical Director/Scientific Director, Medical Affairs Mettawa, Illinois Apply Now

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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

*Hybrid role - 3 days onsite in Lake County, Illinois.

Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.

Responsibilities:

Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
Responsible for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
Participation in design and execution of clinical trial safety, product safety and risk management plans.
Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
May interact with and coordinate 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.
Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

Medical Director Qualifications

Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
Ability to run a clinical study independently with little supervision.
Proven leadership skills in a cross-functional global team environment.
Ability to interact externally and internally to support global business strategy.
Must possess excellent oral and written English communication skills.

Scientific Director Qualifications

Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred.
Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
Ability to run a clinical study independently with little supervision.
Proven leadership skills in a cross-functional global team environment.
Must possess excellent oral and written English communication skills.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

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