Responsibilities
- Lead and oversee a team of toxicologists and technical staff, fostering scientific excellence, collaboration, and professional development.
- Provide strategic leadership for nonclinical safety assessment programs supporting discovery, development, and regulatory submissions.
- Collaborate across disciplines (pathology, DMPK, biology, clinical, regulatory, pharmacology) to ensure strong cross-functional integration.
- Engage with regulatory authorities to support product defense and contribute to successful submissions and approvals.
- Design and implement scientifically robust, strategically aligned nonclinical development programs for drug candidates and regulatory filings.
- Lead and manage nonclinical studies across a portfolio of projects, conducted internally and through CRO partners.
- Prepare and critically review scientific and regulatory documents.
- Partner with cross-functional teams to design investigative toxicology studies.
- Present key findings and safety strategies to program teams, R&D leadership, and regulatory authorities.
- Mentor and develop toxicologists and scientists.
Qualifications
- PhD in Toxicology, Pathology, or related scientific discipline.
- 15+ years of pharmaceutical/biotechnology experience with regulatory toxicology expertise.
- Proven leadership experience managing scientific teams.
- Experience preparing/supporting global regulatory submissions.
- Ability to interpret/integrate complex, multi-disciplinary datasets with focus on clinical relevance.
- Creative/strategic approach to predictive toxicology challenges.
- Strong problem-solving, organization, and ability to lead in a fast-paced environment.
- Excellent interpersonal and written/verbal communication skills.
- Strong interest in therapeutic/scientific areas aligned with the companyβs research focus.