Scientific Director / Senior Medical Director, US Medical Affairs-Rheumatology

Job Description

Position is based at the Mettawa IL office and will follow a hybrid schedule of 3x/week onsite.

The Scientific Director / Senior Medical Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities for AbbVie’s Rheumatology RA/JIA/GCA Therapeutic Area. Responsibilities include engaging with health-care professionals and providers; generating clinical and scientific data to enhance the therapeutic benefit and value of our RA asset; educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and 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 from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
• Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. As the SD Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes partnering with Discovery colleagues on the design and implementation of translational strategies.
• Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• May 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. Serves as the scientific team interface for key regulatory discussions.
• Provide 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.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities..

Qualifications

Position will be commensurate with experience and education.

Scientific Director Qualifications:

• Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
• Strong Medical Affairs capability (7-10 years), with a proven track record across core medical affairs activities (data generation, scientific communications, KOL engagement, and cross-functional strategy). Typically 10-15 years of experience in the pharmaceutical industry or equivalent.
• Knowledge of evidence generation strategy (real-world evidence, investigator-initiated and company-sponsored studies, registries; brand strategy development, scientific communications development, medical insights, and promotional review
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Proven leadership skills in a cross-functional global team environment.
• Must possess excellent oral and written English communication skills.

Senior 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.

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