Global Director, Nonclinical Safety & Toxicology

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

Job summary

Bausch + Lomb is seeking a Senior Director of Pharma Toxicology to lead the organization responsible for global nonclinical safety across our pharmaceutical, OTC, and consumer portfolios. You will define strategy, manage CROs, and interact with FDA and health authorities to align development plans with business goals.

The role requires 15+ years in nonclinical toxicology, a Ph.D., and proven leadership. Expect collaboration with R&D, Regulatory, and Commercial teams to accelerate timelines while

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.
• Proven 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.
• Experience managing departmental budgets and strategic CRO/vendor relationships.
• Proven ability to influence senior leadership and communicate complex scientific risk clearly to executive and non-technical audiences.
• Experience in ophthalmology drug development is highly desirable.
• DABT preferred.

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.

Skills

Leadership experience

Regulatory strategy

Nonclinical safety

FDA interactions

Budget management

Executive communication

Ophthalmology exposure

Education

Ph.D. in Toxicology or related discipline

Job description

Bausch + Lomb is seeking a Senior Director of Pharma Toxicology to lead the organization responsible for global nonclinical safety across our pharmaceutical, OTC, and consumer portfolios. You will define strategy, manage CROs, and interact with FDA and health authorities to align development plans with business goals.

The role requires 15+ years in nonclinical toxicology, a Ph.D., and proven leadership. Expect collaboration with R&D, Regulatory, and Commercial teams to accelerate timelines while