Scientific Director OR Medical Director, Medical Affairs - EPI (GI Care)

Posted on Sep 21, 2024 by AbbVie
Mettawa, IL
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description

*Onsite in Lake County, IL preferred. Will consider remote candidates.

*Position title will be based on qualifications listed below.

The Scientific Director for Medical Affairs in GI Care for exocrine pancreatic insufficiency (EPI) provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: evidence generation through execution of clinical trials and real-world analyses (e.g., therapeutic benefit, safety and medical value), HCP and stakeholder interactions (e.g, professional societies, patient & payer groups), educational initiatives, and interpretation of clinical and scientific data for scientific communications. They serve as a core cross-functional Medical partner for key medical affairs strategic deliverables including comprehensive gap assessment, scientific communications platforms, scientific narratives, integrated evidence plans, and medical strategic plans to drive innovation and life cycle management of our medicines.

Responsibilities:

In collaboration with Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects. Works closely with Brand Teams and relevant cross-functional teams to provide strategic input into core scientific strategy, and to drive Medical Affairs activities and evidence gap closure.

Lead or provide input into the design, analysis, interpretation, and reporting of scientific and medical data and information across study protocols, Investigator Brochures, Clinical Study Reports, publications/presentations 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 assigned assets, disease, and evidence;  develops and maintains professional relationships with key opinion leaders; actively participates in relevant asset, development, and pipeline cross-functional teams to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans, evidence-generation, publications, content generation, and protocols.

Assist in the development of scientifically accurate marketing materials, medical education programs, advisory boards, and symposia, among others. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.

Ensures projects are completed on time, on budget, and in compliance with AbbVie’s policies and regulatory requirement.

Reference: 202107767

https://jobs.careeraddict.com/post/95493078

Scientific Director OR Medical Director, Medical Affairs - EPI (GI Care)

Posted on Sep 21, 2024 by AbbVie

Mettawa, IL
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description

*Onsite in Lake County, IL preferred. Will consider remote candidates.

*Position title will be based on qualifications listed below.

The Scientific Director for Medical Affairs in GI Care for exocrine pancreatic insufficiency (EPI) provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: evidence generation through execution of clinical trials and real-world analyses (e.g., therapeutic benefit, safety and medical value), HCP and stakeholder interactions (e.g, professional societies, patient & payer groups), educational initiatives, and interpretation of clinical and scientific data for scientific communications. They serve as a core cross-functional Medical partner for key medical affairs strategic deliverables including comprehensive gap assessment, scientific communications platforms, scientific narratives, integrated evidence plans, and medical strategic plans to drive innovation and life cycle management of our medicines.

Responsibilities:

In collaboration with Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects. Works closely with Brand Teams and relevant cross-functional teams to provide strategic input into core scientific strategy, and to drive Medical Affairs activities and evidence gap closure.

Lead or provide input into the design, analysis, interpretation, and reporting of scientific and medical data and information across study protocols, Investigator Brochures, Clinical Study Reports, publications/presentations 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 assigned assets, disease, and evidence;  develops and maintains professional relationships with key opinion leaders; actively participates in relevant asset, development, and pipeline cross-functional teams to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans, evidence-generation, publications, content generation, and protocols.

Assist in the development of scientifically accurate marketing materials, medical education programs, advisory boards, and symposia, among others. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.

Ensures projects are completed on time, on budget, and in compliance with AbbVie’s policies and regulatory requirement.

Reference: 202107767

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