Lead AbbVie’s safety pharmacology strategy with primary responsibility for cardiovascular risk assessment and CNS coverage across modalities (small molecules, biologics, peptides, ADCs). Serve as the program level SME from nonGLP exploratory signal detection through GLP IND enabling packages, shaping development decisions, representing the function at governance, and authoring/responding to regulatory submissions (IBs, INDs/CTAs, NDAs/BLAs).

This senior role influences multiple assets of high complexity through cross functional leadership, clear scientific judgment, and effective communication with discovery, development, and regulatory partners. The function operates as an integrated, lab anchored group with in-house capabilities ranging from ion channel assays and cell culture models to isolated tissue and in vivo telemetry, enabling rapid, coordinated safety strategy and translation.

Responsibilities:

• Own cardiovascular safety strategy across the portfolio and provide CNS safety coverage. Integrate in vitro, ex vivo, and in vivo findings to inform risk assessment and mitigation.
• Serve as Safety Pharmacology SME on multidisciplinary teams from lead optimization through filing. Present clear go/no-go recommendations and development risk narratives at governance.
• Design, oversee, and interpret nonGLP exploratory safety pharmacology studies. Plan and coordinate GLP IND enabling studies in partnership with early discovery and GLP toxicology teams.
• Author and contribute to regulatory documents (IBs, INDs/CTAs, NDAs/BLAs) and respond to agency queries (US and ex-US) with sound, data driven rationale.
• Provide ICH S7A/S7B leadership and integrate key cardiovascular and neurologic datasets (e.g., hERG/QT, hemodynamic, telemetry, neurobehavioral, seizure liability assessments) into coherent translational guidance.
• Contribute to technical due diligence for external opportunities. Partner with Business Development to evaluate safety pharmacology risk and recommend deal structures or mitigation plans.
• Represent AbbVie in industry consortia, working groups and external collaborations.  Build scientific credibility through publications, presentations, and cross company initiatives.
• Mentor and develop safety pharmacology and nonclinical colleagues. Support capability roadmaps, method evolution, and best practice dissemination across programs and sites.
• Ensure alignment with Discovery, DMPK, Regulatory, Biostats/Clin Pharm, QA, and Toxicology so that program milestones are met with appropriate risk controls and contingency plans.

Key Collaborators: Project teams (Discovery to Development), Toxicology (early & GLP), DMPK, Discovery Biology, Regulatory Affairs, Clinical Pharmacology, Biostatistics, QA, and Business Development/Transactions.