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United States
Remote only
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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Pharma Toxicology based in the United States.
The Senior Director, Pharma Toxicology will provide enterprise-wide leadership for nonclinical safety across a diverse pharmaceutical, over-the-counter, and consumer health portfolio. This strategic role will define global toxicology direction while ensuring that development programs meet the highest scientific, regulatory, and patient-safety standards. Reporting to R&D leadership, you will serve as the senior scientific authority on toxicology, guiding critical decisions from early development through registration and lifecycle management. You will lead and develop a high-performing toxicology organization while building strong relationships with internal stakeholders, external experts, and regulatory authorities. Working across R&D, Clinical, Regulatory, Quality, and Commercial functions, you will help accelerate development timelines and support sound portfolio decisions. This is an opportunity to shape global nonclinical safety strategy and contribute to the advancement of innovative healthcare products.
In this role, you will establish the strategic direction of nonclinical safety while overseeing scientific execution, organizational development, and regulatory alignment across the portfolio. Your key responsibilities will include:
Global Toxicology Strategy: Define and own the global nonclinical safety and toxicology strategy for pharmaceutical, over-the-counter, and consumer products, ensuring alignment with R&D priorities and corporate objectives.
Scientific and Regulatory Leadership: Serve as the senior toxicology expert, representing the organization in discussions with the FDA and other global health authorities. Lead nonclinical strategies for key regulatory milestones, including pre-IND, IND, end-of-phase, NDA/MAA, and post-approval activities.
Business Development Support: Lead nonclinical due diligence for licensing, acquisitions, and strategic partnerships, advising senior leadership on scientific risks and integration requirements.
Scientific and Regulatory Innovation: Monitor emerging regulatory guidance, scientific developments, and industry standards, including New Approach Methodologies and alternatives to animal testing, and drive their appropriate adoption.
Organizational Leadership: Build, lead, and develop a high-performing toxicology team, establishing clear objectives, managing performance, and supporting succession and talent planning.
People Development: Foster a culture of scientific excellence, accountability, and collaboration through coaching, mentoring, and professional development.
External Partnerships: Establish and manage strategic relationships with Contract Research Organizations (CROs) and external scientific experts, overseeing vendor selection, contracts, performance, and study quality, including GLP compliance.
Nonclinical Program Oversight: Direct the design, execution, interpretation, and communication of nonclinical safety programs supporting clinical development, regulatory submissions, product launches, lifecycle management, and ongoing compliance.
Scientific Review and Governance: Provide final scientific review and approval of nonclinical regulatory submission sections, safety assessments, and technical reports, ensuring consistency and scientific rigor.
Cross-Functional Collaboration: Partner with senior leaders across Product Development, Clinical Development, Analytical Chemistry, Regulatory Affairs, Quality, Compliance, and Commercial teams to align nonclinical strategies with program and business objectives.
Global Coordination: Work with international sites to address nonclinical safety requirements for country-specific submissions, registrations, and ongoing business activities.
Process Excellence: Develop, implement, and continuously improve global departmental processes, standards, and best practices, promoting harmonization across sites.
External Scientific Representation: Strengthen the organization's scientific reputation through publications, conference presentations, and participation in industry consortia.
The ideal candidate will bring extensive pharmaceutical industry experience, deep scientific expertise in toxicology, and a proven ability to lead global nonclinical safety strategies. You should demonstrate strong organizational leadership, regulatory knowledge, and the ability to influence senior stakeholders. Required qualifications include:
Ph.D. in Toxicology or a related scientific discipline.
15+ years of relevant pharmaceutical industry experience in nonclinical safety or toxicology.
Demonstrated people leadership experience, including managing managers and building or scaling teams.
Proven track record of defining and executing nonclinical strategies across multiple development programs, from discovery through registration and lifecycle management.
Direct experience interacting with the FDA and/or other global health authorities.
In-depth knowledge of global nonclinical regulatory requirements and guidance, including ICH guidelines and GLP regulations.
Experience managing departmental budgets and strategic CRO and vendor relationships.
Strong ability to influence senior leadership and communicate complex scientific risks clearly to executive and non-technical audiences.
Excellent strategic thinking, decision-making, communication, and cross-functional collaboration skills.
Experience in ophthalmology drug development is highly desirable.
Diplomate of the American Board of Toxicology (DABT) certification is preferred.
Must be authorized to work for any employer in the United States. Visa sponsorship or transfer is not available.
Salary: Estimated annual starting pay range of $225,000–$300,000, depending on qualifications, experience, and other relevant factors.
Incentives: Eligibility for short-term and/or long-term incentive programs.
Healthcare Coverage: Medical, dental, and vision insurance.
Financial Protection: Disability and life insurance coverage.
Retirement: 401(k) plan with company matching contributions.
Education Support: Tuition reimbursement for selected degree programs.
Paid Time Off: Company holidays, paid vacation, sick time, and floating holidays.
Well-being: Access to employee well-being benefits.
Work Arrangement: Remote position within the United States.
