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
- Collaborate with toxicology and regulatory consultants, as well as internal experts, to lead the design and conduct of toxicology studies, and contribute to interpretation and reporting of results
- Independently formulate clinical pharmacology 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
- 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; experience in Oncology drug development preferred and leading Clinical Pharmacology aspects for late-stage programs (e.g., pivotal trial design, NDA/MAA filings) a plus
- Extensive experience and expertise in small molecule and biologics ADME, PK and PD data analyses; advanced capabilities in modeling and simulation desirable
- 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
- A strong team player with a passion for science and helping discover and develop therapies for unmet medical needs
Silverback Therapeutics is a privately held biopharmaceutical company advancing a pipeline of therapies that are systemically delivered, but locally active and target fundamental disease pathways. Silverback’s ImmunoTAC™ platform enables innovative therapeutic approaches to oncology, virology and fibrotic diseases. Silverback’s lead candidate, SBT6050, is comprised of a potent TLR8 agonist conjugated to a HER2-directed monoclonal antibody, designed for systemic delivery with tumor-localized activation of myeloid cells. Clinical investigation of SBT6050 is expected to begin in 2020, for patients with HER2-expressing solid tumors. Since its inception in 2016, Silverback has raised over $125 million in venture capital. The Company is headquartered 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.