Director, Safety Pharmacology

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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.

• PhD with 10+ years of relevant safety pharmacology experience in the pharmaceutical industry at a pharma, biotech or CRO.
• Demonstrated experience guiding programs through IND and NDA/BLA/MAA milestones.
• Strong experience designing, overseeing, and interpreting GLP and non‑GLP safety pharmacology studies with clear translational reasoning.
• Excellent working knowledge of regulatory expectations and core safety pharmacology paradigms, including ICH S7A/S7B and relevant cardiovascular/CNS assay packages.
• Proven ability to author high quality scientific documents and to communicate complex risk assessments to technical and executive audiences.
• Extensive knowledge of drug discovery and development processes and effective collaboration with partner functions (Discovery, Tox, DMPK, Clin Pharm, Regulatory, QA, Biostats).
• Interdisciplinary safety pharmacology expertise with depth in cardiovascular and exposure to CNS.
• Evidence of prior supervisory/people leadership (formal or matrix) and mentoring.
• Demonstrated influence and negotiation skills; ability to drive alignment under uncertainty and make principled, time‑bound recommendations.

Preferred:

• Experience across multiple modalities (small molecules and biologics, peptides, ADCs) and therapeutic areas (e.g., oncology, neuroscience, immunology).
• External visibility (Safety Pharmacology working groups, publications, invited talks) and experience engaging with global regulatory bodies.
• Veterinary training and/or significant exposure to translational pharmacology.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• This opportunity will observe a hybrid work model (3x days on-site per week) and ideally be located in AbbVie's HQ, north of Chicago, IL. 
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​
• This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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