Senior Director -Project Toxicologist - Clinical Pharmacology and Safety Sciences (Boston or Gaithersburg)
Core
Design and execute global regulatory toxicology strategies for late-stage clinical development and marketed products to assess and mitigate safety risks.
Role type
Senior Director, Project Toxicologist (Regulatory Toxicology and Safety Pharmacology)
Builds
Global regulatory toxicology strategies and pre-clinical toxicology packages for new medicines and established brands.
Domain
Pharmaceutical/Biotech, Oncology, Respiratory, Immunology, Cardiovascular, Renal, Metabolic Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory toxicology strategy, non-clinical safety evaluation, integrated risk assessment, global marketing application support, regulatory defense, mentorship/coaching, cross-functional coordination, small molecule/peptide/oligonucleotide modality expertise
Preferred skills
Experience with in-licensing opportunities, coaching others through regulatory processes, inclusive leadership
Technologies
None stated
Responsibilities
Design regulatory toxicology strategies to assess and mitigate safety risks; Author and defend clinical trial and marketing applications; Coach teams through global marketing applications and regulatory defense; Conduct specialist non-clinical safety evaluation of in-licensing opportunities
Seniority
Senior Director, strategy & mentorship
