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Bausch Lomb

Makes eye medicines, lenses and surgical devices

Senior Director - Pharma Toxicology

Biology & BiotechUpdated on Nov 14
Full-timeRemote in USA

About the Job

Requirements

  • A Ph.D. in Toxicology or a related discipline is required.
  • At least 15 years of relevant pharmaceutical industry experience in nonclinical safety or toxicology is required.
  • People leadership experience, including leading managers and building or scaling teams, is required.
  • A demonstrated track record of setting nonclinical strategy for multiple programs from discovery through registration and lifecycle management, including direct interaction with the FDA or other global health authorities, is required.
  • Deep knowledge of global nonclinical regulatory requirements and guidance, including ICH, and GLP regulations is required.
  • Experience managing departmental budgets and strategic CRO/vendor relationships is required.
  • The candidate must be able 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 certification is preferred.

Responsibilities

  • Define and own the global nonclinical safety and toxicology strategy for pharmaceutical, over-the-counter, and consumer products, aligned with the R&D portfolio and corporate objectives.
  • Act as the company's senior toxicology subject matter expert, represent the company in meetings with the FDA and other global health authorities, and lead nonclinical strategy for regulatory milestones including 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.
  • Coach and mentor team members to support their scientific and professional growth, and foster a culture of scientific excellence, accountability, and collaboration.
  • Establish strategic relationships with Contract Research Organizations 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 supporting clinical development, regulatory submissions and 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 development, implementation, and continuous improvement of global departmental processes, standards, and best practices, and drive harmonization across sites.
  • Represent the company externally through scientific publications, conference presentations, and industry consortia to enhance its scientific reputation.

Desired Qualifications

  • Experience in ophthalmology drug development.
  • DABT certification.

About the Company

Bausch Lomb

Makes eye medicines, lenses and surgical devices

Bausch + Lomb develops and sells eye-health products for patients, consumers and clinicians, spanning everyday vision correction, prescription treatment and eye surgery. Its portfolio combines contact lenses and lens-care solutions with medicines for eye conditions and equipment used in cataract, retinal and refractive procedures. The company also sells surgical consumables and implanted lenses, supplying products used both at home and in clinical settings. It earns revenue through product sales across its vision care, pharmaceuticals and surgical businesses. Founded as an optical goods store in Rochester in 1853, Bausch + Lomb is headquartered in Vaughan, Ontario, with its U.S. headquarters in Bridgewater, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Vaughan, Canada
Founded
1853

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