Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to join our team and contribute to the discovery, preclinical and clinical development of innovative immune-modulating therapeutics. This position is responsible for devising, implementing, and leading strategies to characterize the toxicologic properties of potential drug candidates, playing a critical role in advancing molecules through all stages of drug discovery and development. The successful candidate will make key contributions to regulatory filings and in determining clinical dose levels for initial clinical trials, and will be comfortable working in a dynamic, fast-paced, and collaborative environment.
- Serve as the Development Sciences/Toxicology Lead on multiple discovery and/or development teams, guiding characterization of safety properties of novel biologics to support decision-making and the advancement of preclinical programs and clinical drug candidates.
- Lead the design and conduct of exploratory, non-GLP, and GLP toxicology studies and the interpretation and reporting of results in the context of mechanisms of action or toxicity, dose- and exposure-response relationships, and the impact to predicted safety margins or therapeutic indices for putative drug candidates.
- Contribute to the design and conduct of related in vitro and in vivo studies (eg. pharmacology, pharmacokinetics) in collaboration with other team members, such as chemists, pharmacologists, bioanalytical scientists, and external contributors at contract research organizations.
- Independently formulate program toxicology strategy for and draft relevant sections of key documents supporting regulatory submissions (e.g., INDs).
- Interpret, summarize, and present data to internal project teams, senior management, and external partners/organizations.
- D. in toxicology or a related field and 10+ years of biotech/pharmaceutical drug discovery and development experience; Diplomate, American Board of Toxicology (or equivalent) preferred; title will be commensurate with experience.
- Regulatory experience supporting IND/CTA filings; experience in oncology drug development highly preferred and leading toxicology strategy for late-stage programs (e.g., pivotal trial design, NDA/MAA filings) a plus.
- Depth of experience and expertise devising toxicology strategy aligned with regulatory guidance and precedence, and in conducting toxicology studies for biologics programs is essential, with small molecule and ADC experience preferred.
- Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex toxicology study results and their impact to program and regulatory strategy.
- Detail-oriented while also retaining the ability to see the big picture.
- Flexible, results oriented and demonstrated ability to work in a fast-paced, timeline-driven environment.
- Excellent problem-solving and decision-making skills; provides strong critical thinking and constructive feedback.
- Proven ability to effectively communicate and collaborate with internal team and external collaborators.
- Will work tirelessly to foster an environment of transparency and direct dialogue.
- A strong team player with a passion for science and helping discover and develop therapies for unmet medical needs.
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to firstname.lastname@example.org. We are an equal opportunity employer.