Associate Director/Director, Preclinical Safety:
About the role
The Director, Preclinical Safety is responsible for designing, overseeing, and interpreting the appropriate toxicology studies to advance small molecule drug candidates into the clinic. This role partners closely with Treeline’s clinical and regulatory teams to generate the data package necessary to support clinical development. In addition, the Director of Preclinical Safety will collaborate with Treeline’s drug discovery and translational research teams to provide scientific and strategic input for programs, ensure toxicology efforts are aligned with the overall development strategy, and lead investigative efforts to resolve preclinical safety issues. The Director Preclinical Safety will also be responsible for authoring relevant sections of key regulatory documents and should have a strong knowledge of best regulatory practices. Excellent interpersonal and communication skills are essential in this highly visible role to work effectively within the cross-functional program teams.
- Design, execute, monitor, and interpret non-GLP and GLP toxicology studies for Treeline development candidates.
- Lead multidisciplinary investigative efforts to address/resolve program-related toxicology issues/concerns and ensure studies are performed in accordance with overall program timelines
- Select, partner, and interface with contract research organizations (CROs) running toxicology studies, including gathering quotes, providing input during protocol development, monitoring timelines and data quality, reviewing data and study activities, and presenting data and conclusions to project teams
- Participate on multidisciplinary project teams and implement program or platform-specific toxicology strategies to de-risk new drug targets, early chemical matter and lead series, and potential drug candidates.
- Represent toxicology as a subject matter expert to project teams by interpreting toxicology results and presenting conclusions and next steps to cross-functional program teams
- Write and/or review relevant nonclinical safety sections of regulatory documents such as INDs, NDAs, briefing books to support clinical trials and drug registration globally and help resolve nonclinical safety queries
- Maintain a current understanding of toxicology literature, methodology and regulatory requirements.
- D. in Toxicology, Molecular and/or Cellular Biology, or related field, with 8+ years of industry-related experience in Preclinical Development and Toxicology working within the pharmaceutical or biotechnology industry
- Diplomate of the American Board of Toxicology (DABT) is strongly preferred.
- Knowledge of biochemical and mechanistic toxicology with demonstrated ability to interpret toxicology data and lead toxicology strategic decisions.
- Extensive experience in the outsourcing and external oversight of preclinical Toxicology studies conducted by qualified contract research organizations (CROs).
- Previous experience with the preparation of the preclinical safety sections of regulatory documents such as pre-IND, IND, IB, briefing documents, and CTA
- Demonstrated knowledge of global regulatory requirements and expectations (GLP, ICH and other applicable global guidelines) for nonclinical safety assessment packages to support first in human, clinical development.
- Excellent time management, problem solving skills and ability to work and lead in a cross-functional setting.
- Ability to exercise good judgment, strong analytical and organization skills, and attention to detail required.
- Strong communication, interpersonal, collaboration and multi-tasking skills are required
- Ability to thrive in a fast-paced, dynamic environment and under tight timelines.
The anticipated annual base salary range for candidates who will work in San Diego is $173,670 to $237,258. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
Treeline Biosciences is committed to protecting the health and safety of our team. Our company requires all employees to be fully vaccinated against COVID-19, including a booster shoot. Proof of vaccination must be provided prior to the first day of employment. As required by applicable law, Treeline will consider requests for Reasonable Accommodations.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.