Project Toxicologist, Director – Oncology Targeted Delivery (OTD) Safety Science, Clinical Pharmacology and Safety Sciences (Cambridge, MA or Gaithersburg, MD)
Core
Lead toxicology strategies for novel targeted oncology therapies (radioconjugates, ADCs, small molecules) to predict, assess, and mitigate safety risks from discovery to regulatory submission.
Role type
Director, Project Toxicologist (Oncology R&D)
Builds
Investigative and regulatory toxicology programs supporting IND filings and development milestones for oncology drugs.
Domain
Oncology drug discovery and development / Preclinical safety science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project toxicology leadership, investigative toxicology, regulatory toxicology, oncology drug discovery knowledge, IND filing support, in vitro/in silico/in vivo safety assessment, cross-functional coordination, scientific communication, strategic planning
Preferred skills
Radioconjugate expertise, ADC experience, small-molecule oncology therapeutics knowledge, organ-on-chip and omics integration, external collaboration (in-licensing/due diligence)
Technologies
organ-on-chip, imaging, omics
Responsibilities
Design and oversee regulatory and investigative toxicology programs; Apply toxicology expertise to anticipate clinical safety risks and provide data-driven recommendations; Integrate in vitro, in silico, and in vivo approaches with emerging technologies; Present scientific conclusions and safety strategies to governance bodies; Maintain and expand expertise in regulatory standards and modality-specific toxicology; Provide strategic toxicology input for in-licensing and due diligence activities
Seniority
Director, strategic leadership with hands-on scientific oversight