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 understand drug disposition, PKPD, and 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 dose selection for initial and pivotal clinical trials, and will be comfortable working in a dynamic, fast-paced, and collaborative environment. This position is preferably based in Seattle, but flexible for the right candidate.
- Serve as the Development Sciences/Clinical Pharmacology Lead on multiple discovery and/or development teams, guiding characterization of ADME and PKPD properties to enable program and clinical drug candidate advancement.
- Lead or contribute to the design and conduct of related in vitro and in vivo studies in collaboration with other team members (e.g., chemists, pharmacologists, bioanalytical scientists) and external contributors at contract research organizations.
- Perform PKPD data analyses, modeling and simulation to predict and characterize drug candidate human PKPD characteristics and dose-exposure-response relationships, guiding optimal dose selection for clinical trials.
- Independently formulate clinical pharmacology strategy for and draft relevant sections of key documents supporting regulatory submissions (e.g., INDs).
- Collaborate on toxicology study design and incorporate results into the determination of safety margins, therapeutic index, and rationale for clinical dose regimens.
- Interpret, summarize, and present data to internal project teams, senior management, and external partners/organizations.
- Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or a related field and 10+ years of biotech/pharmaceutical drug discovery and development experience.
- Regulatory experience supporting IND/CTA filings and experience leading Clinical Pharmacology strategy for oncology programs in early development; experience with late-stage programs (e.g., pivotal trial design, NDA/MAA filings) a plus.
- Depth of experience and expertise in small molecule and biologics ADME, PK and PD data analyses are essential; experience with ADCs and advanced capabilities in modeling and simulation preferred.
- Strong understanding of bioanalytical method development/validation and toxicology assessments in drug discovery and development, including pertinent regulatory guidance.
- Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate (orally and in writing) complex PK/PD/modeling 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.
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.