Senior Clinical Trial Specialist (PKU)

Maze Therapeutics, Inc.; South San Francisco (CA); Híbrido; USD 125.000 - 152.000; Jornada completa

Descripción de la vacante

Maze Therapeutics, Inc. is seeking a Senior Clinical Trial Specialist to support Clinical Operations on a PKU study. You will work with internal teams, CROs and vendors to ensure smooth execution, staying organized and proactive in a fast-paced biotech environment.

The role emphasizes vendor and site management, trial documentation, and compliance with ICH/GCP guidelines. Hybrid work schedule with onsite presence in South San Francisco, CA.

Formación

• Bachelor's degree with 2-3+ years of experience in Clinical Operations within biotech/pharma.
• Strong problem-solving mindset and attention to detail.
• Exceptional organizational skills with ability to manage multiple priorities.
• Proactive and collaborative team player with internal/external partners.
• Hands-on experience with trial systems (Medidata Rave, Veeva or similar).
• Willingness to travel 10-15% as needed.
• Strong proficiency with Microsoft Office Suite (Word, Excel, Outlook).

Responsabilidades

• Driving Study Execution: oversee global Phase 2 PKU study progress and corrective actions.
• Site, Vendor Management & Oversight: lead CRO/site oversight and budget management from start to close.
• Manage one or more clinical trial vendors, day-to-day and escalation.
• Identify gaps, hold vendors/CRAs accountable, provide solutions.
• Ensure compliance with ICH/GCP, study plans, and Maze SOPs.
• Assist in design/review of study documents (ICFs, protocols, amendments).
• Attend vendor meetings and drive issue resolution with external partners.
• Oversee TMF activities, metrics tracking, and reconciliation.

Conocimientos

Clinical ops

Problem-solving

Organizational skills

Collaboration

MS Office

Travel flexibility

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

Medidata Rave

Veeva

Descripción del empleo

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.

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.

The Impact You’ll Have

• 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 elevate 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.

What We’re Looking For

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.

About Maze Therapeutics

Maze Therapeutics is a clinical‑stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases. Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease. We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.

Our People

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

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, freedom of expression, and a stimulating atmosphere where people enjoy coming to work.

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.