Job Details
Title: Senior Scientist / Non Clinical Safety Evaluation
Location: Waltham, MA
Duration: 6+ Months
Part Time role : 20 hours per week
Position Summary:
Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet Mural Oncology s Discovery and Development goals; these deliverables include management/coordination of contracts, study-related documentation (protocols/reports), and regulatory submission documents, and program-related documents (e.g., candidate nomination). The role requires close collaboration with external contract research organizations (CROs) and Mural Oncology s Head of NSE/toxicologist.
Responsibilities including but not limited to:
Review and QC NSE study protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs
Review and QC NSE information in regulatory documents (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)
Review and QC NSE information in candidate nomination documents and presentation slides (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)
Process Work orders, Change orders and track invoices against installment payments in contracts
Prepare and/or review/QC NSE meeting abstracts, presentation material, as needed
Support Head of NSE/toxicologist, as needed
Education and Experience:
BS/MS with 6-10 years of experience in biotech/pharma or CRO in a nonclinical safety assessment organization or Quality Assurance group; PhD with 0-3+ years of applicable experience
Exceptional attention to detail
Strong oral and written communication skills
Ability to work successfully independently and collaboratively
Significant knowledge of GLP regulations for the conduct of NSE studies
Considerable experience reviewing:
GLP NSE study protocols, reports, amendments
NSE sections of regulatory documents
Familiarity with drug development process
Familiarity with NSE studies required for registration of biologics for cancer
Knowledge of regulatory submissions and NSE guidance for biologics for cancer
Experience with contract work and tracking invoices