VP, Head of Clinical Operations

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div> </div> <div>Led by Tassos Giannakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.</div> <div> </div> <div>We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.</div> <div> </div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div> </div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div> </div> <div> </div></div><p><strong><span data-contrast="auto">Role Summary</span></strong><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">The Head of Clinical Operations is a senior leadership role responsible for the </span><strong><span data-contrast="auto">end-to-end execution of global clinical trials</span></strong><span data-contrast="auto">, ensuring delivery on timelines, quality, and budget. This role leads the </span><strong><span data-contrast="auto">Clinical Trial Management</span></strong><span data-contrast="auto"> and </span><strong><span data-contrast="auto">Global Site Management</span></strong><span data-contrast="auto"> functions, providing strategic and operational oversight across all phases of development.  This role is a member of the Development Operations & Biometrics leadership team, and, as such, contributes to portfolio strategy, evidence generation, and long-range planning.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">The position is accountable for translating development strategy into executable clinical plans, building scalable operating models, and ensuring compliant, high-quality trial conduct across regions and sites.</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Key Responsibilities</span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Provide strategic and operational leadership for the planning and execution of global clinical trials across the portfolio.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Oversee study start-up, conduct, and close-out activities in collaboration with cross-functional partners.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Ensure clinical trials are delivered on time, within scope, and within budget.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Establish standardized trial management processes, tools, and metrics to support consistency and scalability.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Serve as the primary operational escalation point for study-level risks, issues, and mitigation strategies.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Build and oversee the Global Site Management function, ensuring global site strategy, including site identification, feasibility, selection, initiation, monitoring, and close-out.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Oversee regional and global monitoring models (in-house, hybrid, CRO-managed, RBQM).</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Develop and guide site engagement, performance, and retention strategies to optimize enrollment, quality, and timelines.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Ensure consistent application of GCP, ICH, and regional regulatory requirements across sites.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Partner with Quality Assurance to support inspections, audits, and CAPA management related to site activities.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Drive enrollment acceleration initiatives and proactive risk-based approaches to recruitment and retention.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Monitor enrollment performance and implement corrective actions as needed.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Partner with Development Services, Procurement, and Legal to support CRO and vendor oversight.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Provide clinical operations input into vendor selection, governance, and performance management.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Collaborate closely with Biometrics, Regulatory, Medical, Quality, and Safety to ensure integrated trial execution.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">B</span><span data-ccp-parastyle="Normal (Web)">uild, lead, and develop high-performing Clinical Trial Management and Site Management teams.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Establish clear roles, responsibilities, and career pathways within Clinical Operations.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="20" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Support organizational growth by designing scalable operating models and resourcing strategies.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="21" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Ability to assess and transform capabilities through AI and Automation solutions or strategies</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="22" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Foster a culture of accountability, quality, and continuous improvement.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="23" data-aria-level="1"><span data-contrast="auto">Up to 20-30% domestic and international travel, as required.</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Qualifications & Preferred Skills </span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="24" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Bachelor’s degree </span><span data-ccp-parastyle="Normal (Web)">in Life Sciences </span><span data-ccp-parastyle="Normal (Web)">required</span><span data-ccp-parastyle="Normal (Web)">; advanced degree (MS, MPH, PharmD, PhD) preferred.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="25" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">15+ years of clinical operations experience within biotech, pharma, or CRO environments.</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">12+ years with an advanced degree</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="26" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Proven leadership experience overseeing clinical trial management and global site management functions.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="27" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Experience leading global, multicenter trials across multiple phases, including late-stage and registration studies preferred.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="28" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"> </span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$300,000</span><span class="divider">—</span><span>$360,000 USD</span></div></div></div>