Nonclinical Operations Manager

ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, Shape^TX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing. The Shape^TX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. You can find us at shapetx.com and on LinkedIn and Twitter.

At Shape^TX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases.

Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Boston, Massachusetts.

Shape^TX is looking for a Nonclinical Operations Manager to join the Nonclinical Development (NCD) team. In this role, the successful candidate will act as a study monitor for toxicology and biodistribution studies conducted at external contract research organizations (CROs), helping to advance ShapeTX therapeutic candidates and novel engineered AAV capsids toward clinical application. The candidate will leverage their operational and scientific knowledge to assist in the planning, execution, sample management, and reporting for nonclinical studies, ensuring that they are conducted in compliance with study protocols, standard operating procedures (SOPs), and, when appropriate, Good Laboratory Practice (GLP) regulations. The candidate will work closely with nonclinical study directors, project team functional representatives, bioanalytical laboratory scientists, pathologists, and laboratory operations. Strong organizational skills, attention to detail, clear and effective communication, and the ability to balance competing priorities to meet project timelines in a fast-paced start-up environment is critical.

Title and compensation will be commensurate with level of experience.

Responsibilities:

• Contract studies with external CROs, draft study protocols, and monitor study operations
• Plan studies to ensure adherence to project timelines and budget
• Ensure nonclinical studies are conducted according to the highest standards of science, quality, and animal welfare
• Work with NCD management to review study designs, protocols/amendments, reports, and other study-related documents
• Collaborate with cross-functional team members (research, CMC, regulatory, project management, etc) in execution of study deliverables
• Ensure proper organization and recording of study data
• Assist in the preparation of written study reports to meet regulatory requirements
• Audit external CROs to ensure studies are being conducted according to study protocol, SOPs, and relevant regulatory requirements. This will include observation of critical study activities
• Maintain regular contact with CRO study directors to ensure up-to-date knowledge of study status and findings
• Keep project representatives and NCD management apprised of study progress, findings, and results
• Communicate potential issues related to CRO performance to NCD management
• Maintain current knowledge of external technical capabilities to enable CRO selection to fit scientific needs
• Build and maintain business relationships with study directors and CRO collaborators
• Serve as nonclinical laboratory operations lead, ensuring accurate sample registry/inventory, equipment validation/performance, and EH&S compliance
• Draft departmental SOPs and manage NCD staff training records
• Travel up to 10% (domestic and/or international)

Qualifications:

• Bachelor’s degree in life discipline with 5 years relevant biotech/pharmaceutical industry experience OR
• Master’s degree and 3 years of relevant experience
• Understanding of gene therapy drug development process and cross-functional roles/responsibilities
• Deep experience with nonclinical study design and execution to evaluate drug pharmacokinetics, pharmacodynamics, and toxicology
• Experience managing CRO activities and auditing GLP laboratories for compliance
• Demonstrated ability to multi-task, prioritize, anticipate challenges, problem solve, and achieve high quality outcomes
• Excellent organizational and operational skills including attention to detail, documentation, report writing, and project/timeline management

We aspire to Shape Life! not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences.