Sr. Director, Toxicology and Biocompatibility

What You'll Do:

TheSr. Director, Toxicology and Biocompatibility provides strategic and scientific leadership for the global nonclinical development strategy encompassing toxicology and biocompatibility evaluations to support the development of novel ophthalmic therapeutics, including small molecules, biologics, and extended duration drug delivery systems. This role drives the integrated nonclinical planning required for the submission of INDs, IMPDs, NDAs, and MAAs in alignment with regulatory expectations across international markets.

This individual will lead a growing team of scientists and strategic leaders responsible for the design, oversight, and interpretation of nonclinical programs supporting drug and combination product development. The Senior Director is accountable for ensuring the nonclinical strategy aligns with and enables the clinical development plan, including comprehensive evaluation of local and systemic toxicity and biocompatibility and toxicological risk assessments.

The Senior Director will collaborate extensively with early research, clinical development, regulatory, CMC, and program leadership teams to ensure seamless transition of assets into and through clinical development. This includes oversight of GLP and non-GLP toxicology, tolerability and biocompatibility studies, and integration of complex, cross-functional datasets to drive development decisions and regulatory submissions. The role requires seasoned leadership in mentoring staff, advancing innovative preclinical strategies, and fostering scientific excellence internally and with external partners.

The Senior Director will also represent the function at key internal governance bodies, external regulatory interactions, and scientific forums. This leader plays a critical role in shaping the overall R&D strategy by bringing a nonclinical lens to portfolio prioritization and risk management.

• Lead the development and execution of integrated nonclinical, toxicology, and biocompatibility strategies to support early- to late-stage drug development programs.
• Provide scientific and regulatory guidance to ensure high-quality nonclinical and biological evaluation data packages aligned with global regulatory requirements and clinical development objectives in support of regulatory submissions.
• Oversee nonclinical study designs, ensuring alignment with strategic goals, appropriate regulatory compliance (GLP), and scientific rigor.
• Serve as the senior functional representative on cross-functional development teams, regulatory interactions, and due diligence efforts.
• Develop and influence project strategies by interpreting complex nonclinical data and articulating implications for safety, dosing, and clinical development.
• Build, mentor, and lead a high-performing team of scientists, fostering an environment of collaboration, innovation, accountability, and professional growth.
• Oversee external CRO partners and consultants to ensure timely execution and quality delivery of studies and reports.
• Own budget planning and oversight, ensuring effective resource allocation across internal and outsourced activities.
• Maintain an up-to-date understanding of FDA, EMA, ICH, and other relevant regulatory guidance; ensure incorporation of evolving scientific standards into development programs.
• Lead and contribute to the strategic direction of the pharmaceutical development organization, participating in portfolio-level decision-making and long-range planning.
• Champion the development of new models, technologies, or processes that enhance translational relevance or streamline nonclinical workflows.

How You'll Get There:

• 15+ years of relevant biopharmaceutical industry experience, including extensive leadership of nonclinical toxicology functions.
• Minimum 6 years of successful people and/or cross-functional leadership experience.
• DABT certification is strongly preferred.
• Proven expertise in ophthalmic drug development, with in-depth knowledge of relevant animal models, translational considerations, and preclinical safety evaluation.
• Demonstrated success in developing and executing nonclinical strategies that enable global regulatory submissions (INDs, CTAs, NDAs, MAAs).
• Extensive experience managing external partnerships, including CROs and scientific consultants.
• Track record of contributing to clinical development strategies and navigating cross-functional R&D environments.
• Deep knowledge of GLP regulations, compliance frameworks, and global regulatory expectations for nonclinical development.
• Exceptional written and verbal communication skills, including authoring and reviewing regulatory documents and presenting to senior leadership, regulators, and external stakeholders.
• Highly organized, detail-oriented, and capable of managing multiple complex projects simultaneously in a dynamic environment.
• Strategic thinker and collaborative leader who inspires and motivates teams