Work In Biotech
Director / Senior Director, Preclinical / Translational Sciences
Work In Biotech, Seattle, Washington, us, 98127
Confidential Search: Director / Senior Director, Preclinical/Translational Sciences
Location:
Seattle, WA (Hybrid)
Company:
Stealth-mode biotechnology venture
Position Summary A stealth-mode biotechnology company in Seattle is seeking an experienced
Director or Senior Director of Preclinical & Translational Sciences
to own and drive all activities required to advance a monoclonal antibody program from candidate selection through IND submission and beyond. This role is central to building the scientific foundation of the company and leading the integrated preclinical strategy across virology, pharmacology, structural/biophysical characterization, PK/PD, toxicology, and other IND-enabling workstreams.
Given the company’s small, agile structure, this leader must be highly hands‑on, able to operate independently, and adept at orchestrating a network of CROs, consultants, and academic partners. This position represents a rare opportunity to directly shape development strategy, execution, and regulatory readiness at an early inflection point.
Key Responsibilities Define, integrate, and drive the critical path to IND, ensuring that study designs, timelines, and data packages meet regulatory expectations for prophylactic monoclonal antibody development. Lead preparation of IND content for relevant modules (nonclinical, pharmacology, safety, supporting scientific rationale). Coordinate cross‑functional inputs—CMC, clinical planning, regulatory—into a coherent regulatory strategy. Oversee study documentation, audit readiness, and data quality suitable for inclusion in regulatory filings.
Virology & Pharmacology Leadership Design and oversee in vitro virology and neutralization assays, viral challenge studies, and mechanistic evaluations supporting candidate nomination and dose projection. Ensure translational relevance of pharmacology packages, linking in vitro/in vivo findings to human hypotheses and target product profile.
Structural & Biophysical Characterization Direct external partners conducting structural biology, epitope mapping, and biophysical studies (e.g., cryo‑EM, crystallography, SPR/BLI) to inform lead optimization and support regulatory justification of mechanism.
PK/PD & Nonclinical Safety Studies Guide design and interpretation of PK and PK/PD studies in appropriate animal models; collaborate with modeling experts to inform first‑in‑human dose selection. Oversee GLP and non‑GLP toxicology, safety pharmacology, immunogenicity assessments, and tissue cross‑reactivity studies required for IND.
External Partnership Management Serve as day‑to‑day scientific lead for CROs, consultants, and academic collaborators across multiple development disciplines. Ensure program execution is aligned with timelines, budget, and regulatory objectives.
Leadership in a Small, Stealth Environment Operate as a hands‑on scientific leader capable of independently managing complex workstreams. Contribute to company‑level scientific strategy and scenario planning. Help establish development processes, quality expectations, and operational discipline appropriate for a pre‑clinical company preparing for its first IND.
Qualifications Required
Ph.D. in Virology, Immunology, Molecular Biology, Pharmacology, or related field. 10+ years of industry experience in biologics development. Demonstrated success leading monoclonal antibody programs through IND-enabling studies and into early clinical development, and preferably to BLA. Hands‑on expertise in virology, antibody pharmacology, and/or viral pathogenesis. Strong understanding of structural and biophysical characterization of antibody–antigen interactions. Extensive experience overseeing PK, toxicology, and other nonclinical studies with CROs. Ability to thrive in a lean, resource‑limited startup environment with minimal internal infrastructure.
Preferred
Experience in infectious disease prophylaxis or antiviral antibodies. Familiarity with regulatory interactions (pre‑IND meetings, written responses, etc.). Experience building foundational development capabilities within an early‑stage company.
Why This Role? Direct ownership of the scientific and operational path to the company’s first IND. High‑impact leadership role within a small, stealth‑stage team. Opportunity to build core development capabilities and shape overall strategy. Competitive compensation and meaningful equity participation.
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Location:
Seattle, WA (Hybrid)
Company:
Stealth-mode biotechnology venture
Position Summary A stealth-mode biotechnology company in Seattle is seeking an experienced
Director or Senior Director of Preclinical & Translational Sciences
to own and drive all activities required to advance a monoclonal antibody program from candidate selection through IND submission and beyond. This role is central to building the scientific foundation of the company and leading the integrated preclinical strategy across virology, pharmacology, structural/biophysical characterization, PK/PD, toxicology, and other IND-enabling workstreams.
Given the company’s small, agile structure, this leader must be highly hands‑on, able to operate independently, and adept at orchestrating a network of CROs, consultants, and academic partners. This position represents a rare opportunity to directly shape development strategy, execution, and regulatory readiness at an early inflection point.
Key Responsibilities Define, integrate, and drive the critical path to IND, ensuring that study designs, timelines, and data packages meet regulatory expectations for prophylactic monoclonal antibody development. Lead preparation of IND content for relevant modules (nonclinical, pharmacology, safety, supporting scientific rationale). Coordinate cross‑functional inputs—CMC, clinical planning, regulatory—into a coherent regulatory strategy. Oversee study documentation, audit readiness, and data quality suitable for inclusion in regulatory filings.
Virology & Pharmacology Leadership Design and oversee in vitro virology and neutralization assays, viral challenge studies, and mechanistic evaluations supporting candidate nomination and dose projection. Ensure translational relevance of pharmacology packages, linking in vitro/in vivo findings to human hypotheses and target product profile.
Structural & Biophysical Characterization Direct external partners conducting structural biology, epitope mapping, and biophysical studies (e.g., cryo‑EM, crystallography, SPR/BLI) to inform lead optimization and support regulatory justification of mechanism.
PK/PD & Nonclinical Safety Studies Guide design and interpretation of PK and PK/PD studies in appropriate animal models; collaborate with modeling experts to inform first‑in‑human dose selection. Oversee GLP and non‑GLP toxicology, safety pharmacology, immunogenicity assessments, and tissue cross‑reactivity studies required for IND.
External Partnership Management Serve as day‑to‑day scientific lead for CROs, consultants, and academic collaborators across multiple development disciplines. Ensure program execution is aligned with timelines, budget, and regulatory objectives.
Leadership in a Small, Stealth Environment Operate as a hands‑on scientific leader capable of independently managing complex workstreams. Contribute to company‑level scientific strategy and scenario planning. Help establish development processes, quality expectations, and operational discipline appropriate for a pre‑clinical company preparing for its first IND.
Qualifications Required
Ph.D. in Virology, Immunology, Molecular Biology, Pharmacology, or related field. 10+ years of industry experience in biologics development. Demonstrated success leading monoclonal antibody programs through IND-enabling studies and into early clinical development, and preferably to BLA. Hands‑on expertise in virology, antibody pharmacology, and/or viral pathogenesis. Strong understanding of structural and biophysical characterization of antibody–antigen interactions. Extensive experience overseeing PK, toxicology, and other nonclinical studies with CROs. Ability to thrive in a lean, resource‑limited startup environment with minimal internal infrastructure.
Preferred
Experience in infectious disease prophylaxis or antiviral antibodies. Familiarity with regulatory interactions (pre‑IND meetings, written responses, etc.). Experience building foundational development capabilities within an early‑stage company.
Why This Role? Direct ownership of the scientific and operational path to the company’s first IND. High‑impact leadership role within a small, stealth‑stage team. Opportunity to build core development capabilities and shape overall strategy. Competitive compensation and meaningful equity participation.
#J-18808-Ljbffr