PreClinical Safety Project Manager (CONTRACT)

Orna Therapeutics • Watertown, MA

78d • $61 - $78

About The Position

We’re looking for a motivated and proactive Project Manager (CONTRACT) to drive operations within the Preclinical Safety Team encompassing discovery R&D 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 internally as well as externally to deliver on program timelines & track milestones/deliverables and help advance our mission to bring forward novel therapies for patients. This role involves interfacing with Contract Research Organizations (CROs) and internal stakeholders including the internal in vivo team to manage study planning, 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.
• Proficiency in managing preclinical studies and interfacing with CROs.
• Strong understanding of GLP regulations and other relevant regulatory guidelines.
• Experience with project planning tools such as Smartsheet or Project
• Experience with data management systems and electronic data capture.
• Proven ability to anticipate challenges in study planning and implementation and to develop solutions rapidly to avoid study delays or failures without increasing costs.
• Demonstrated ability to work collaboratively in a cross-functional team environment including, CROs, and others.
• Excellent organizational and project management abilities.
• 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.

Nice To Haves

• Previous experience in small biotech environment highly desirable.

Responsibilities

• Study Planning and Scheduling: Collaborate with internal/external team representatives and project/lab managers to assist in the planning (study no. generation etc), and reporting of non-GLP and GLP studies in Toxicology, DMPK, and BioA functions, ensuring compliance with regulatory requirements as needed.
• Project Management: Oversee and manage timelines, deliverables, and documentation for Toxicology, DMPK, and BioA studies, ensuring projects stay within timelines and within scope.
• Sample/Document Storage and Archiving/Organization: Collaborate with Toxicology, DMPK, and BioA functions to maintain organized records and ensure proper storage of samples, study documents, data, and reports in appropriate locations, databases and document management systems.
• CRO/internal in vivo team Coordination: Collaborate with Contract Research Organizations (CROs) to ensure timely and quality delivery of study data, including study design, data analysis, interpretation and study close out. Also work closely with the internal in vivo team/vendors for outsourced work from internal studies to track data availability.

What This Job Offers

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