Director, Safety Pharmacology

Lead AbbVies 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.

Qualifications :

• 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 nonGLP 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 timebound 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.

Additional Information :

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 AbbVies 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time