Scientific Director, Immunology, Global Patient Safety

AbbVie•North Chicago, IL

4d•$160,500 - $305,000

About The Position

Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drug. Leads development and implementation of an asset safety strategy with support of PST-L or management. Supports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assets. Facilitates scientific connections and interactions, information exchange across assets within the safety teams. Prepares material on competitive intelligence, current disease state, and standard of care for key indications/ disease states. Compiles draft slide presentations for internal and external meetings as required. Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies. Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans. Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action.

Requirements

Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
At least 5+ years of pharmaceutical industry experience, preferably in patient safety/ PV
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
Strategic thinking and capacity of analyzing aggregate data and conclude
Effectively present recommendations / opinions in group environment both internally and externally
Ability to work effectively under circumstances of uncertainty and complexity.
Proven ability to critically evaluate and interpret complex safety data from clinical trials, supporting informed risk-benefit decision-making
Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
Must possess excellent oral and written English communication skills.
Work collaboratively and lead cross-functional teams
Good communication and influence skills
Good organization and mastering Microsoft office tools

Responsibilities

Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drug
Leads development and implementation of an asset safety strategy with support of PST-L or management
Supports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assets
Facilitates scientific connections and interactions, information exchange across assets within the safety teams
Prepares material on competitive intelligence, current disease state, and standard of care for key indications/ disease states
Compiles draft slide presentations for internal and external meetings as required
Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies.
Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans.
Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action