Senior Manager/Associate Director, Nonclinical Study Management

Scribe Therapeutics; Alameda (CA); On-site; USD 140,000 - 230,000; Full time

Benefits offered by this job

Health benefits

Equity

Wellness stipend

Job summary

Scribe Therapeutics is seeking a Senior Manager/Associate Director, Nonclinical Study Management to oversee outsourced GLP studies and ensure regulatory readiness. You will collaborate with internal scientists, CROs, and vendors to drive study execution and maintain high quality standards.

The role involves coordinating quotes, contracts, and reports, tracking deliverables, and enabling timely regulatory submissions. Travel up to 20% domestically and internationally is expected.

Qualifications

• Bachelor’s degree in biology/toxicology/biotechnology or related field.
• 8+ years of related work experience in drug development.
• Proficient knowledge of GLP guidelines for nonclinical studies.
• Experience managing IND enabling studies.
• Excellent verbal and written communication skills.
• Strong attention to detail in study-related documentation.

Responsibilities

• Oversee outsourcing of preclinical (GLP and non-GLP) studies for regulatory submissions.
• Liaise with CROs; manage quotes, contracts, and final reports.
• Provide CRO oversight to ensure consistent practices across sites.
• Monitor deliverables for regulatory compliance and scientific integrity.
• Communicate study updates with internal stakeholders and teams.
• Coordinate global shipment of test articles and samples between CROs.

Skills

Organization

Communication

Compliance

Quality

Problem solving

Education

Bachelor’s degree in biology/toxicology/biotechnology or related field

Job description

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.

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.

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

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.

Requirements

Knowledge Requirements (Background/Skills/Experience):

• Bachelor’s degree in biology/toxicology/biotechnology or a related field
• 8+ years of related work experience in drug development
• Working knowledge of invoicing/accounting/contract management preferred
• Previous experience managing IND enabling studies
• Proficient knowledge in GLP guidelines governing nonclinical safety and toxicology studies
• Excellent verbal and written communication skills
• Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondenc
• Ability to navigate and be successful in a fast-paced program with a dynamic cross-functional team

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Summary

Benefits & Compensation:

Salary and total compensation will be commensurate with experience and will include a competitive benefits package. Scribe provides an intellectually stimulating, collegial, and fast-paced environment. If you are ready to help engineer the future of therapeutics, we are excited to hear from you. Visit us at www.scribetx.com.

• Health: Medical (HMO, PPO, EPO, HDHP), Dental, Vision, Life, Transit, FSA, HSA
• Equity: Meaningful equity that allows you to share in the long-term success of the platform.
• Perks: Wellness stipend, Learning and development opportunities, Cell stipend, home office set up stipend.

Equal Opportunity Employer

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other characteristic protected by applicable law.