Manager, Nonclinical Safety Operations at City Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jan, 26

Salary

0.0

Posted On

23 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GLP Compliance, Toxicology Studies, CRO Management, Study Coordination, Regulatory Compliance, Budget Management, Invoice Reconciliation, Communication Skills, Organizational Skills, Data Collection, Documentation Management, Technical Assessments, Sample Handling, Project Management, Quality Control, Pharmacology

Industry

Biotechnology Research

Description

Position Summary City Therapeutics is seeking a highly organized and detail-oriented Manager, Nonclinical Safety Operations to join our Nonclinical Safety Evaluation (NSE) group within Translational Sciences. This position reports to the Senior Director, NSE and will play a central role in supporting GLP and non-GLP toxicology and other nonclinical safety studies. The individual will serve as the primary operational interface with external CRO partners, ensuring high-quality study execution, documentation, and regulatory compliance. While the primary focus of this role is to support NSE, it will also provide ongoing operational support for NHP pharmacology studies and, on a temporary basis, support other functions such as Clinical Pharmacology and Pharmacokinetics (CPPK) and Bioanalytical and Biotransformation (BABT) within Translational Sciences. Key Responsibilities CRO Management and Oversight Serve as the primary operational point of contact for CROs conducting toxicology, safety pharmacology, and other nonclinical safety studies, ensuring seamless study setup, execution, and reporting. Monitor study conduct from protocol development through reporting and archiving, ensuring GLP compliance, scientific integrity, and alignment with regulatory requirements. Coordinate technical reviews, site visits, and follow-up documentation with internal scientific leads and QA. Travel to CRO sites to perform technical assessments, monitor key study phases, and prepare site visit reports documenting observations and follow-up actions. Internal Study Support Coordinate and monitor the conduct of internal and exploratory nonclinical safety studies, ensuring adherence to protocols, timelines, and quality standards. Facilitate communication between internal scientists, project managers, regulatory leads, and leadership to ensure alignment on study objectives, timelines, and deliverables. Manage logistics for test article and sample handling, data collection, and document archiving. Study Tracking & Logistics Manage operational activities including study contracting, reviewing and executing SOWs, generating study and PO numbers, and coordinating with Finance and Legal as needed. Coordinate test article and sample shipments to and from CROs, ensuring proper storage before, during, and after delivery. Oversee financial tracking by monitoring installment-based study invoices, ensuring accuracy, timely approvals, and alignment with approved budgets. Track study progress and maintain oversight of contract deliverables and milestone-based payments to support accurate forecasting and project planning. Documentation & Compliance Coordinate and manage QC review of study protocols, reports, and regulatory documents to ensure accuracy, completeness, and submission readiness. Maintain study documentation in compliance with internal SOPs, GLP standards, and international regulatory guidelines (FDA, EMA, ICH). Maintain regulatory documentation in electronic systems (e.g., Veeva Vault, SharePoint), ensuring version control, traceability, and audit readiness. Qualifications Ph.D. (3+ years), MS (7+ years), or BS (9+ years) in toxicology, pharmacology, biotechnology, or related life sciences. Demonstrated experience managing GLP and non-GLP toxicology studies and working with CROs in a biotech or pharmaceutical setting. Must have prior experience monitoring non-human primate (NHP) studies. Experience overseeing contracting, budgeting, and invoice reconciliation for CRO-based studies is required. Excellent organizational skills with attention to detail, and ability to manage multiple studies in parallel. Strong written and verbal communication skills with ability to build productive vendor and cross-functional relationships. Willingness to travel to CRO sites as needed. Comfortable working in a fast-paced, highly collaborative environment. Additional Information This role is required to be on-site at our offices in Cambridge, MA five days a week. City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment agency submissions will not be accepted at this time. City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership, or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing); or any other characteristic protected by law.

Responsibilities

The Manager, Nonclinical Safety Operations will oversee GLP and non-GLP toxicology studies, ensuring high-quality execution and compliance with regulatory standards. This role involves managing external CRO partnerships and coordinating internal study support across various functions within Translational Sciences.