Global Head of Nonclinical Toxicology — Pharma

Bausch + Lomb; Helena (MT); On-site; USD 225,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement

Job summary

Bausch + Lomb seeks a Senior Director, Pharma Toxicology to lead nonclinical safety across its pharmaceutical, OTC, and consumer portfolios. The role reports to R&D leadership and sets the global toxicology strategy while building a high-performing team and serving as the company’s senior scientific authority on toxicology for development programs and regulatory interactions.

The position requires 15+ years in nonclinical safety, strong leadership, and deep knowledge of regulatory

Qualifications

• Ph.D. in Toxicology or related discipline.
• 15+ years of relevant pharmaceutical industry experience in nonclinical safety/toxicology.
• People leadership experience, including leading managers and building or scaling teams.
• Demonstrated track record of setting nonclinical strategy for multiple programs from discovery through registration and lifecycle management, including direct interaction with the FDA and/or other global health authorities.
• Deep knowledge of global nonclinical regulatory requirements and guidance (e.g., ICH) and GLP regulations.

Responsibilities

• Define and own the global nonclinical safety and toxicology strategy for pharmaceuticals, over-the-counter products, and consumer goods, aligned with the R&D portfolio and corporate objectives.
• Act as the company's senior subject matter expert in toxicology, representing Bausch + Lomb in meetings with the FDA and other global health authorities and leading nonclinical strategy for key regulatory milestones (e.g., pre-IND, IND, end-of-phase, NDA/MAA, and post-approval).
• Lead nonclinical due diligence for in-licensing, acquisition, and partnership opportunities, and advise senior leadership on nonclinical risks and integration requirements.
• Anticipate evolving regulatory guidance, scientific advances, and industry standards (including New Approach Methodologies and alternatives to animal testing); assess portfolio-wide impact and drive adoption where appropriate.
• Build, lead, and develop a high-performing toxicology organization; set goals, manage performance, and drive succession and talent planning.
• Foster a culture of scientific excellence, accountability, and collaboration; coach and mentor team members to support their scientific and professional growth.
• Establish strategic relationships with Contract Research Organizations (CROs) and external experts; oversee vendor selection, contracting, performance, and study quality (including GLP compliance).
• Oversee the design, execution, interpretation, and communication of nonclinical safety programs to enable clinical development, regulatory submissions/registrations, product launch, ongoing market support, and compliance activities.
• Provide final scientific review and approval of nonclinical sections of regulatory submissions, safety assessments, and technical reports; ensure scientific rigor and consistency across the portfolio.
• Partner with executive and cross-functional leaders including Product Development, Clinical Development, Analytical Chemistry, Regulatory Affairs, Quality, Compliance, and Commercial to align nonclinical plans with program and business objectives.
• Direct collaboration with international company sites to address nonclinical safety requirements for country-specific submissions, registrations, and ongoing business needs.
• Lead the development, implementation, and continuous improvement of global departmental processes, standards, and best practices, and drive harmonization across sites.
• Represent Bausch + Lomb externally through scientific publications, conference presentations, and industry consortia, enhancing the company's scientific reputation.

Education

Ph.D. in Toxicology or related discipline

Job description

Bausch + Lomb seeks a Senior Director, Pharma Toxicology to lead nonclinical safety across its pharmaceutical, OTC, and consumer portfolios. The role reports to R&D leadership and sets the global toxicology strategy while building a high-performing team and serving as the company’s senior scientific authority on toxicology for development programs and regulatory interactions.

The position requires 15+ years in nonclinical safety, strong leadership, and deep knowledge of regulatory