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Senior Clinical Trial Manager, Early Development

Maze Therapeutics · Maze Therapeutics is a biotechnology company that develops precision medicines for renal, cardiovascular, and metabolic diseases.

South San Francisco, CA101-250 employeesPosted 13 days ago
Post-IPO Equity · $150Mraised 6 months agoled by Andreessen Horowitz, General Catalyst, ARCH Venture Partners

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<h3><strong>The Position</strong></h3> <p><span class="TextRun SCXW43566753 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">. As a&nbsp;</span></span><span class="TextRun MacChromeBold SCXW43566753 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">Senior Clinical Trial Manager (Sr. CTM)</span></span><span class="TextRun SCXW43566753 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">&nbsp;at Maze Therapeutics,&nbsp;</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">you’ll</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">&nbsp;play a hands-on role in driving the execution of our clinical trials.&nbsp;</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">You’ll have the opportunity to lead&nbsp;</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">Early Development</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">&nbsp;studies, work cross-functionally with internal teams and external partners, and ensure&nbsp;</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">studies</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">&nbsp;run efficiently and with the highest quality standards.</span><span class="NormalTextRun SCXW43566753 BCX0" data-ccp-parastyle="Normal (Web)">&nbsp;If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you.</span></span><span class="EOP SCXW43566753 BCX0" data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></p> <h3><strong>The Impact You’ll Have</strong></h3> <ul> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Clinical Trial Execution &amp; Leadership</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead the planning, execution, and delivery of Clinical Pharmacology and early-phase trials (e.g., FIH, SAD/MAD, DDI,</span><span data-ccp-parastyle="Normal (Web)">&nbsp;b</span><span data-ccp-parastyle="Normal (Web)">ioavailability/bioequivalence</span><span data-ccp-parastyle="Normal (Web)">&nbsp;</span><span data-ccp-parastyle="Normal (Web)">and renal/hepatic impairment studies) from study design through CSR completion.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Serve as the operational lead for assigned studies, managing cross-functional&nbsp;</span><span data-ccp-parastyle="Normal (Web)">meetings</span><span data-ccp-parastyle="Normal (Web)">&nbsp;and driving achievement of key milestones (FPI, enrollment completion, interim analyses, database lock, and CSR).</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Collaborate closely with Clinical Pharmacology, Clinical Science, and Translational Medicine to align operational plans with scientific and regulatory&nbsp;</span><span data-ccp-parastyle="Normal (Web)">objectives</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead study feasibility assessments and contribute to dose escalation strategy, cohort planning, and adaptive study design considerations to ensure&nbsp;</span><span data-ccp-parastyle="Normal (Web)">timely</span><span data-ccp-parastyle="Normal (Web)">&nbsp;and efficient execution.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Partner with Clinical Science and Clinical Pharmacology&nbsp;</span><span data-ccp-parastyle="Normal (Web)">lead</span><span data-ccp-parastyle="Normal (Web)">&nbsp;to engage therapeutic area experts and KOLs, support advisory board meetings, and provide input on study rationale and design.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Vendor</span><span data-ccp-parastyle="Normal (Web)">,</span><span data-ccp-parastyle="Normal (Web)">&nbsp;</span><span data-ccp-parastyle="Normal (Web)">CRO&nbsp;</span><span data-ccp-parastyle="Normal (Web)">&amp; Site&nbsp;</span><span data-ccp-parastyle="Normal (Web)">Management</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Lead and&nbsp;</span><span data-ccp-parastyle="Normal (Web)">facilitate</span><span data-ccp-parastyle="Normal (Web)">&nbsp;request for proposals from CROs and clinical trial vendors through final vendor selection as well as budget and contract negotiations</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Oversee</span><span data-ccp-parastyle="Normal (Web)">&nbsp;CRO and vendor onboarding, and day-to-day oversight, ensuring adherence to budgets, protocols, and ICH-GCP guidelines.&nbsp;</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Budget &amp; Financial Oversight</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Support Clinical Operations Leadership with study-specific budget tracking and vendor&nbsp;</span><span data-ccp-parastyle="Normal (Web)">spend</span><span data-ccp-parastyle="Normal (Web)">&nbsp;management.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Data Quality, Compliance &amp; Regulatory Readiness</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Process Optimization &amp; Technology Implementation</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS) to enhance efficiency.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Assist</span><span data-ccp-parastyle="Normal (Web)">&nbsp;in developing SOPs and scalable processes for clinical operations.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1"><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Cross-functional Collaboration</span></span></strong><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Partner with internal teams, such as CMC and Clinical Supply Chain, to&nbsp;</span><span data-ccp-parastyle="Normal (Web)">manage study</span><span data-ccp-parastyle="Normal (Web)">&nbsp;drug supply and distribution. Work closely with other&nbsp;</span><span data-ccp-parastyle="Normal (Web)">functions to ensure smooth study execution.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true}">&nbsp;</span></li> </ul> </li> </ul> <h3><strong>What We’re Looking For</strong></h3> <ul> <li><span data-contrast="auto">A&nbsp;Bachelor’s&nbsp;degree in a scientific&nbsp;discipline or health related field with&nbsp;5–8&nbsp;years of clinical operations experience, including at least 4 years as a CTM, with hands-on experience managing&nbsp;Clinical Pharmacology&nbsp;or early-phase&nbsp;studies.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Demonstrated experience managing Phase&nbsp;I&nbsp;and early development trials across healthy volunteer and patient populations, including first-in-human&nbsp;and bridging studies.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Strong understanding of Clinical Pharmacology principles, including pharmacokinetics, pharmacodynamics, bioanalytical sampling, and PK data workflows.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP)</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Experience&nbsp;conducting&nbsp;a broad range of clinical trial related activities&nbsp;including&nbsp;study start-up to study close-out,&nbsp;clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Strong executional leadership, problem-solving skills, and ability to manage cross-functional teams at the study level.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">A&nbsp;startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team&nbsp;environment.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Excellent communication skills and the ability to manage cross-functional relationships effectively.</span><span data-ccp-props="{}">&nbsp;</span></li> <li><span data-contrast="auto">Are willing to</span><strong><span data-contrast="auto">&nbsp;travel up to&nbsp;5-10%</span></strong><span data-contrast="auto">&nbsp;to support study needs.</span><span data-ccp-props="{}">&nbsp;</span></li> </ul> <h3><strong>About Maze Therapeutics</strong></h3> <p>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.&nbsp; Maze is based in South San Francisco.</p> <h3><strong>Our People</strong></h3> <p>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.&nbsp;</p> <p><strong>Our Core Values</strong></p> <p><span style="color: rgb(233, 104, 82);"><strong>Further Together</strong></span> – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.&nbsp;</p> <p><span style="color: rgb(132, 39, 107);"><strong>Impact Obsessed</strong></span> – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.</p> <p><span style="color: rgb(58, 193, 205);"><strong>Stand True</strong></span> – Our integrity is foundational; it guides us no matter the obstacle.</p> <hr> <p>The expected annual salary range for employees located in the San Francisco Bay Area is <span class="NormalTextRun SCXW264346226 BCX0" data-ccp-parastyle="Normal (Web)">$17</span><span class="NormalTextRun SCXW264346226 BCX0" data-ccp-parastyle="Normal (Web)">6</span><span class="NormalTextRun SCXW264346226 BCX0" data-ccp-parastyle="Normal (Web)">,000 - $21</span><span class="NormalTextRun SCXW264346226 BCX0" data-ccp-parastyle="Normal (Web)">5</span><span class="NormalTextRun SCXW264346226 BCX0" data-ccp-parastyle="Normal (Web)">,000.</span> 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.</p> <p>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.</p> <p><span style="color: rgb(255, 255, 255);">#LI-Hybrid</span></p>
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