Scientific Director / Senior Medical Director, US Medical Affairs-Rheumatology at AbbVie · LumiJobs

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..
Position will be commensurate with experience and education.
Scientific Director Qualifications:
Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.

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

Responsibilities

Benefits

Company

AbbVie

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