Senior Clinical Trial Specialist (PKU)

Job Description

Job Description

The Position

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.

You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include:

• Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
• Site, Vendor Management & Oversight:
  • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight.
  • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate.
  • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
• Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
• Supporting Key Study Materials: Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
• Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners.
• Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
• Sample & Data Management: Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts.
• Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
• Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution.

We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have:

• A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
• A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes.
• Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track.
• A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners.
• Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
• Flexibility and adaptability: You thrive in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed.
• Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary.
• Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook).

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week.

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco.

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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