Talent.com
Associate Director, Clinical Operations - PKU South San Francisco, CA

Associate Director, Clinical Operations - PKU South San Francisco, CA

MazetxSan Francisco, CA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.temporary
job_description.job_card.job_description

Overview

Associate Director, Clinical Operations – PKU at Maze Therapeutics leads PKU clinical development strategy and trial execution. This role partners with cross-functional teams to manage the PKU Phase 2 study, guiding study design, protocol development, and key milestones. The position offers ownership of the clinical program, collaboration with key opinion leaders, and leadership within Clinical Operations.

Responsibilities

  • Clinical Trial Execution & Leadership

Lead or co-lead the Phase 2 PKU clinical trial, aligning execution with the overall clinical development plan from study design and protocol development to completion of milestones (FPI, enrollment, interim analysis, database lock, CSR).

  • Drive feasibility and site selection to ensure timely enrollment; develop enrollment forecasts.
  • Partner with Clinical Science to engage therapeutic area KOLs and plan clinical advisory committee meetings.
  • Participate on the Clinical Development Sub-Team (CDST) and contribute to clinical development strategy.
  • Lead and facilitate engagement with clinical trial vendors, including budget and contract negotiations
  • Oversee CROs, vendors, and study sites to ensure alignment with strategic goals
  • Budget & Financial Oversight
  • Provide financial oversight across multiple clinical studies, ensuring budget efficiency and alignment with corporate goals

  • Data Quality, Compliance & Regulatory Readiness
  • Ensure high-quality clinical trial data and adherence to study protocols, SOPs, ICH GCP; oversee CROs / vendors and monitoring at sites.

  • Partner with Quality Assurance on inspection readiness.
  • Process Optimization & Technology Implementation
  • Identify and integrate emerging technologies (AI / ML-driven solutions, analytics) to improve trial planning and execution.

  • Develop best practices and scalable processes with the Clinical Operations Team.
  • Evaluate and implement off-the-shelf systems (eTMF, CTMS, RBM) as appropriate.
  • Cross-functional Collaboration
  • Influence program-wide decisions by collaborating with regulatory, data science, CMC, supply chain, and other stakeholders.

    Leadership Competencies

    As an Associate Director, leadership capabilities include :

  • Communication and Influence
  • Communicate rationale behind decisions and foster open communication with internal and external stakeholders.

  • Teamwork and Collaboration
  • Facilitate collaboration across teams and manage conflicts constructively.

  • Execution and Results
  • Use data-driven judgment, support team problem-solving, and reinforce process compliance and risk mitigation.

  • Develop Others and Self
  • Articulate expectations and pursue ongoing development for self and team.

    Qualifications

    You might be the right fit if you have :

  • A Bachelor’s degree in a scientific discipline or health-related field with 8–10 years in clinical operations, including leadership of Phases I–III trials, with program-wide and strategic focus.
  • Experience in common disease and / or rare disease drug development.
  • Familiarity with regulatory guidelines and inspections (FDA, EMA, ICH-GCP).
  • Proven capability planning, conducting, and managing clinical trials from start-up to close-out; experience with clinical trial databases (e.g., Medidata RAVE, Veeva) and budgeting.
  • Strong strategic thinking, ability to shape development strategy and influence management at study and program levels.
  • Startup mindset, ability to work in a fast-paced, evolving, collaborative environment.
  • Experience providing program-level leadership and mentoring junior staff; 1–2 years of people management with direct reports is highly desirable.
  • Excellent communication skills and ability to influence stakeholders.
  • Willing to travel up to 30% to support study needs.
  • About Maze Therapeutics

    Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for renal, cardiovascular, and related metabolic diseases, including obesity. The company uses its Compass platform to map genetic variants to biological pathways and develop targeted therapies. Maze is based in South San Francisco.

    Our People and Values

    We are a team of professionals committed to transforming patients’ lives through science. We foster an environment that encourages vision, initiative, and talent development, while maintaining a patient-centric focus.

    Core Values

  • Further Together – Team-first approach to overcome challenges.
  • Impact Obsessed – Bold actions, calculated risks, and learning from results.
  • Stand True – Integrity as a foundation for all decisions.
  • Compensation & Benefits

    The expected annual salary range for employees located in the San Francisco Bay Area is $185,000 - $226,000. This position is eligible for an annual bonus. Maze conducts compensation benchmarking. Starting salary depends on experience, skills, and location. Benefits include medical, dental, vision, mental health offerings, equity, 401(k) with employer match, and generous holiday and PTO policies.

    Other Information

    Maze supports a hybrid work environment. #LI-Hybrid

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Associate Director Clinical • San Francisco, CA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Associate Director, Analytics & Insights Lead (Remote)

    Associate Director, Analytics & Insights Lead (Remote)

    Jazz PharmaceuticalsPalo Alto, CA, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Clinical Operations

    Associate Director, Clinical Operations

    Corcept TherapeuticsRedwood City, CA, US
    serp_jobs.job_card.full_time
    Associate Director, Clinical Operations.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Clinical Trials Associate

    Clinical Trials Associate

    VirtualVocationsSanta Clara, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Clinical Trials Associate responsible for clinical trials administration to ensure the effective conduct of clinical research studies. Key Responsibilities Support Clini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Medical Oncology Director

    Medical Oncology Director

    VirtualVocationsFremont, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Medical Director.Key Responsibilities Conduct clinical case reviews with interdisciplinary teams for anti-cancer therapies Lead multidisciplinary discussions to suppor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Clinical Operations

    Associate Director, Clinical Operations

    Revolution MedicinesRedwood City, CA, US
    serp_jobs.job_card.full_time
    Associate Director, Clinical Operations.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicte...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Director - Mental Health 321

    Clinical Director - Mental Health 321

    Telecare CorporationMartinez, CA, United States
    serp_jobs.job_card.full_time
    They made it easier for me to live, breathe, eat, and stay clean.Without them, I'd be waiting somewhere, waiting for someone to give me a chance to live. Client from Orange County Region.Telecare's ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Senior Associate Clinical Contracts

    Senior Associate Clinical Contracts

    VirtualVocationsFremont, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Sr Associate Clinical Contracts & Budgets.Key Responsibilities Manage all aspects of contracting support, including Confidential Disclosure Agreements, Fee-For-Service ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Medical Director - Utilization Management

    Medical Director - Utilization Management

    VirtualVocationsSan Jose, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Medical Director Utilization Management - Clinical Advocacy and Support.Key Responsibilities : Conduct coverage reviews and render coverage determinations based on membe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Associate Director, Clinical Operations

    Associate Director, Clinical Operations

    Lyell ImmunopharmaSouth San Francisco, CA, US
    serp_jobs.job_card.full_time
    Associate Director, Clinical Operations.Using living cells to treat and sometimes even cure cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies h...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Clinical Operations Associate Director (Biotechnology / Oncology)

    Clinical Operations Associate Director (Biotechnology / Oncology)

    ExelixisAlameda, CA, United States
    serp_jobs.job_card.full_time
    The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams.This position is a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director of Clinical Operations (San Francisco)

    Director of Clinical Operations (San Francisco)

    PowerSan Francisco, CA, United States
    serp_jobs.job_card.full_time
    At Power, we believe every patient should have easy access to clinical trials as a care option.Our platform connects patients to research opportunities quickly, transparently, and compassionately ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Scientific Affairs

    Associate Director, Scientific Affairs

    VirtualVocationsFremont, California, United States
    serp_jobs.job_card.full_time
    A company is looking for an Associate Director, Scientific Affairs.Key Responsibilities Develop high-caliber medical and scientific content adhering to adult learning principles Contribute to gr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Clinical Systems

    Director, Clinical Systems

    Molina HealthcareFREMONT, US
    serp_jobs.job_card.full_time
    Leads and directs a team supporting clinical systems.Responsible for provision of product ownership of clinical applications including design, development, implementation, and oversight of technolo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Clinical Supplies

    Director, Clinical Supplies

    Dynavax TechnologiesEmeryville, CA, United States
    serp_jobs.job_card.full_time
    This position can be 100% remote, but must be located in the United States.Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director Clinical Operations

    Associate Director Clinical Operations

    Meet Life SciencesFremont, CA, US
    serp_jobs.job_card.full_time
    We're Hiring : Senior Clinical Trial Manager / Associate Director, Clinical Operations.San Francisco Bay Area – Hybrid (3 days onsite). Therapeutic Focus : Neurology and / or Immunology Experience Requi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Associate Director Clinical Pharmacology – San Francisco Biotech

    Associate Director Clinical Pharmacology – San Francisco Biotech

    TANNER & ASSOC INCSan Francisco, CA, United States
    serp_jobs.job_card.full_time
    Associate Director Clinical Pharmacology – San Francisco Biotech.New Position : Associate Director Clinical Pharmacology – San Francisco Biotech. The Associate Director role will have a broad range o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Program Director, Psychiatry Residency at FHCSD

    Associate Program Director, Psychiatry Residency at FHCSD

    Family Health Centers of San DiegoEl Cerrito, CA, United States
    serp_jobs.job_card.full_time
    Impact Lives, Impact Community.Family Health Centers of San Diego (FHCSD) is passionate about providing exceptional health care to all, especially underserved communities with limited health care o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Trial Associate II (Contractor)

    Clinical Trial Associate II (Contractor)

    Dynavax TechnologiesEmeryville, CA, United States
    serp_jobs.job_card.full_time
    This position can be 100% remote, but must be located in the United States.Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days