Senior Scientist - Waltham, United States - Integrated Resources, Inc ( IRI )

Description

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