Senior Manager/Associate Director, Nonclinical Study Management

About Scribe:

Scribe Therapeutics is a clinical-stage biotechnology company engineering CRISPR-based technologies into purpose-built in vivo genetic medicines designed to become standard of care treatments for patients suffering from highly prevalent diseases, starting with cardiometabolic disease. Leveraging its CRISPR by Design™ approach and nature’s blueprint for improved cardiovascular health, Scribe’s initial programs focus on addressing the key drivers of ASCVD such as elevated LDL-C, lipoprotein(a), and triglycerides. The company’s lead candidate, STX-1150, is a novel liver-targeted therapy designed to epigenetically silence the PCSK9 gene and reduce LDL-C levels without inducing permanent DNA changes. To broaden and accelerate the impact of its engineered CRISPR technologies for patients, Scribe has formed strategic collaborations with world-leading pharmaceutical companies including Sanofi and Eli Lilly. Co-founded by Nobel Prize winner Jennifer Doudna and backed by leading life sciences investors, Scribe is advancing scalable, transformative, and preventative genetic medicines with the goal of improving outcomes and democratizing access to the protective effects of beneficial human genetics.

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Position Summary:

We are looking for a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. We are looking for a Senior Manager/Associate Director, Nonclinical Study Management to join our team and advance our platform. This position will be responsible overseeing outsourced nonclinical studies to ensure they are conducted ethically and efficiently, in accordance with applicable regulatory requirements and high quality standards, including Good Laboratory Practice (GLP) requirements. The candidate should have a passion for collaborating closely with internal scientists, study directors, and external vendors to drive study execution.

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Competencies:

• Organization
• Communication
• Compliance
• Quality
• Collaboration
• Problem-solving
• Adaptability

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Key Duties / Responsibilities / “What you’ll do”:

• Manage outsourcing of preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacokinetic, toxicology, and biodistribution studies.
• Liaise with CROs, monitoring all aspects from evaluation of quotes/contracts to approval of final reports.
• Act as primary contact and provide oversight to CRO partners to ensure consistent practices across vendors, groups, and sites, communicate and trouble-shoot issues and track activities.
• Monitor and review deliverables for completeness, regulatory compliance, and scientific integrity.
• Communicate study updates regularly with internal stakeholders and project teams.
• Coordinate the global shipment of test articles and biological samples between CROs and vendors.
• Manage and archive of critical documents, samples, and specimens.
• Participate in regular teleconferences with CROs, including pre-study meetings, biweekly CRO programs meetings, and operational meetings.
• Ability to visit sites for study monitoring; up to 20% international and domestic travel.