We are seeking a talented and experienced Senior Director to join our team and play a crucial role in evaluating the safety profiles of our covalently and non-covalently targeted small molecules. The ideal candidate will utilize their toxicology expertise to guide safety assessments and contribute to the design and interpretation of in vitro and in vivo studies while adhering to regulatory guidelines. In this position, you will work closely with the toxicology team, contract research organizations (CROs), and multidisciplinary drug discovery and development teams to advance promising therapeutics toward the clinic.
Responsibilities:
- Serve as the subject matter expert for toxicology within drug discovery and development project teams, guiding strategies for safety characterization, prioritization, and advancement of drug candidates.
- Collaborate closely with Contract Research Organizations (CROs) to manage and oversee the execution of in vitro and in vivo toxicology studies, ensuring the delivery of high-quality data. Review and QC study protocols, results, and reports, and effectively communicate toxicology findings to project teams and senior management.
- Contribute to preparing safety study summaries, nonclinical overviews, and regulatory documents and represent the company during regulatory interactions.
- Provide strategic input for CTA/IND package design and collaborate with cross-functional teams, including chemistry, biology, regulatory, DMPK, CMC, and clinical teams, to support the development of our oncology and immunology portfolios.
- Stay current with evolving regulatory requirements and safety-related challenges and propose new strategies for safety assessments. Participate in industry consortiums and scientific conferences to continue professional development.
- Collaborate with early discovery project teams to conduct literature-based target safety assessments and provide guidance on target safety derisking activities
Requirements
- Ph.D. in toxicology, pharmacology, or closely related biomedical disciplines
- Diplomate of American Board of Toxicology is highly desired
- 10+ years of experience in a pharmaceutical or biotechnology industry setting
- A broad understanding of various aspects of nonclinical safety assessment and regulatory requirements for drug development, experience representing the toxicology function on discovery and development teams is required, and expertise in immunology is highly desired
- Must be able to critically evaluate, interpret, and integrate multidisciplinary data to support target and compound safety assessment
- Experience in the design, conduct, and data interpretation of in vitro and in vivo safety pharmacology, genetic toxicology, immunosafety, and general toxicology studies are required
- Strong track record of regulatory preparation, submissions, and interactions with health authorities
- Experience managing outsourced studies at CROs