Project Manager, PreClinical Safety (CONTRACT)

Orna Therapeutics • Watertown, MA

7d

About The Position

We’re looking for a motivated and proactive Project Manager (Contractor) to track operations within the Preclinical Safety Team encompassing discovery through IND-enabling and other development related activities for Toxicology, Drug Metabolism, and Pharmacokinetics (DMPK) and Bioanalytical (BioA) functions across complex internal and outsourced R&D programs. In this role, you'll collaborate with scientific and operational leaders to deliver on program timelines & track milestones/deliverables and help advance our mission to bring forward novel medicines for patients with unmet needs. This role involves interfacing with Contract Research Organizations (CROs) and internal stakeholders including internal in vivo team to manage study scheduling, coordination, and progress tracking.

Requirements

• 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.

Responsibilities

• Study Timeline Tracking: 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.
• Project Management: 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.
• Document Storage and Archiving: 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.
• CRO Coordination: 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.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 101-250 employees