Global Head of Nonclinical Toxicology – Pharma

Bausch + Lomb

San Juan (PR)

On-site

USD 225,000 - 300,000

Full time

5 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Disability insurance
Life insurance
401(k) with company match
Tuition reimbursement
Company holidays
Well-being benefits
Sick time
Floating holidays
Paid vacation

Job summary

Bausch + Lomb seeks a Senior Director, Pharma Toxicology to lead global nonclinical safety across its pharmaceutical, OTC, and consumer portfolio. You will set the nonclinical safety strategy, build the toxicology organization, and serve as the company’s senior scientific authority with health authorities.

You will partner with R&D, Regulatory, Clinical, Quality and Commercial teams to align nonclinical plans with portfolio goals, oversee GLP studies, and drive risk assessment, lifecycle

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.
  • 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.
  • 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.

Job description

Bausch + Lomb seeks a Senior Director, Pharma Toxicology to lead global nonclinical safety across its pharmaceutical, OTC, and consumer portfolio. You will set the nonclinical safety strategy, build the toxicology organization, and serve as the company’s senior scientific authority with health authorities.

You will partner with R&D, Regulatory, Clinical, Quality and Commercial teams to align nonclinical plans with portfolio goals, oversee GLP studies, and drive risk assessment, lifecycle

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