Director Toxicology

Location: Remote - US based candidates only, no visa sponsorship available. Compensation: $204,000 – $306,000 annually.

About the role

For our client, we are seeking a Director Toxicology to join the team of a leader in the Pharmaceuticals & Biotech space. This leader will oversee global nonclinical regulatory and investigative toxicology activities for assigned development programs, with a focus on advancing complex pharmaceutical assets through key stages of the pipeline. The role partners closely with cross-functional teams, CROs, and regulatory stakeholders to shape nonclinical strategy, support submissions, and ensure study execution aligns with global expectations. This is a highly visible position for a scientific leader who can integrate multidisciplinary data, provide practical guidance, and help drive development decisions in oncology and CNS-focused programs.

Responsibilities

• Manage global nonclinical regulatory and investigative toxicology for assigned products
• Conceptualize and finalize toxicology study designs and regulatory submission documents
• Oversee nonclinical studies at CROs and ensure compliance with global standards
• Review and analyze toxicology data, collaborating with CROs to finalize reports
• Contribute to nonclinical development strategies and provide peer reviews of related reports
• Lead cross-functional teams and ensure integration of toxicology activities into project plans
• Stay current on relevant literature and methodologies related to pipeline products

Qualifications

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology with extensive pharmaceutical industry experience
• Board certification in Toxicology is desirable; eligible candidates should intend to write the exam
• Extensive experience with both small and large molecules, particularly in oncology and CNS indications
• Familiarity with FDA, EMA, and ICH guidelines as well as GLP regulations
• Experience authoring non-clinical elements for major regulatory submissions and preparing responses to regulatory inquiries
• Strong skills in synthesizing and integrating multidisciplinary scientific data
• Excellent communication and scientific writing skills, with a sense of urgency

Benefits

• Eligibility for a discretionary annual cash bonus or incentive compensation
• Discretionary equity grants from the Long Term Equity Incentive Plan
• Medical, dental, and vision insurance options
• 401k retirement savings plan
• Flexible paid vacation