Orna Therapeutics · 17 hours ago
Project Manager, PreClinical Safety (CONTRACT)
Watertown, MA
Full-time, Contract
Onsite
Senior Level
5+ years expOrna Therapeutics is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. The Project Manager will track operations within the Preclinical Safety Team, collaborating with scientific and operational leaders to deliver on program timelines and manage study scheduling and coordination.
BiotechnologyMedicalPharmaceuticalTherapeutics
No H1B
Responsibilities
Collaborate with internal/external team representatives and project managers to assist in the tracking timelines and reports or other related documentation of non-GLP and GLP studies in Toxicology, DMPK, and BioA functions, ensuring compliance with regulatory requirements as needed. Develop, maintain, and update project trackers for nonclinical and cross-functional initiatives using tools like Smartsheet, Project, or similar platforms. Track project milestones, budgets, and timelines to ensure timely delivery
Oversee and manage timelines, deliverables, and documentation for Toxicology, DMPK, and BioA studies, ensuring projects stay within timelines and within scope. Organize, schedule, and support internal and external meetings — create agendas, gather materials, take notes, and manage follow-up actions
Collaborate with colleagues from Toxicology, DMPK, and BioA functions to maintain organized records and ensure proper storage of study documents, data, and reports in appropriate databases and document management systems
Collaborate with Contract Research Organizations (CROs) to work closely with the Project Manager/Client Manager to ensure timely and quality delivery of study data and study close out
Qualification
Required
Master's degree and 5+ years, or Bachelor's degree and 10+ years, in a related scientific discipline such as Biochemistry, Pharmacology, Toxicology, or a related field, and experience in preclinical study management (conducting, scheduling and/or planning Toxicology, DMPK, and BioA studies) within the biopharmaceutical industry or at a CRO
Previous experience supporting timelines and milestones for multiple INDs and managing/tracking preclinical studies and interfacing with CROs
Demonstrated ability to work collaboratively in a cross-functional team environment including, CROs, and others
Excellent organizational and project management abilities. Experience with project planning tools such as Smartsheet or Project
Strong communication and interpersonal skills for effective collaboration with internal teams and external partners
Attention to detail and problem-solving capabilities
Demonstrated ability to manage multiple projects simultaneously and adapt to changing priorities
High level of discretion and professionalism in handling confidential information and multistakeholder relationships
Strong understanding of GLP regulations and other relevant regulatory guidelines
Experience with data management systems and electronic data capture
Company
Orna Therapeutics
Orna Therapeutics is a biotechnology company that specializes in fully engineered circular RNA therapeutics to treat various diseases.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$321MKey Investors
MerckMPM Capital
2022-08-16Series B· $221M
2021-02-24Series A· $80M
2020-01-01Seed· $20M
Leadership Team
Frank Neumann
Chief Medical Officer
Recent News
Labiotech UG
2025-11-15
Company data provided by crunchbase