Scientific Director, Oncology - Global Patient Safety

AbbVie•Florham Park, NJ

5d•$160,500 - $305,000

About The Position

Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities.

Requirements

Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
5+ years of experience in Pharmacovigilance / Clinical Development / Development biological Sciences experience in the pharmaceutical industry.
Proven ability to critically evaluate and interpret complex safety data from oncology clinical trials, supporting informed risk-benefit decision-making
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
Ability to exercise judgment and address complex problems and create solutions across multiple projects
Must be able to lead and manage through influence.
Effectively provide input on technical safety documents
Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
Must possess excellent oral and written English communication skills.
Ability to work effectively under circumstances of uncertainty and complexity.

Responsibilities

Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market.
May lead development and implementation of an asset safety strategy with support of PST-L or management
Leads 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 oncology assets
Facilitate scientific connections and interactions, info exchange across assets within the safety teams
Prepare material on competitive intelligence, current disease state and standard of care for key indications/ disease states
Supports GPS TA in assigned due diligence activities for Oncology.
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 Oncology studies.
Drives process improvement and change management for the Oncology Safety team in conjunction with enterprise-wide and functional area plans.