This job has closed.

Orna Therapeutics · 2 months ago

PreClinical Safety Project Manager (CONTRACT)

Watertown, MA

Contract

Onsite

Senior Level

$60.50/hr - $77.52/hr

5+ years exp

Orna Therapeutics is a Watertown-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. They are seeking a motivated Project Manager to drive operations within the Preclinical Safety Team, managing timelines and deliverables for Toxicology, DMPK, and BioA studies while collaborating with both internal and external stakeholders.

BiotechnologyMedicalPharmaceuticalTherapeutics

No H1B

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

Qualification

Preclinical study managementGLP regulationsProject planning toolsBiochemistryPharmacologyToxicologyData management systemsCommunicationOrganizational abilitiesProblem-solving capabilitiesCollaboration skills

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 in small biotech environment highly desirable

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