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Vice President, Clinical Development, Tonlamarsen (TLA)

kardigan

South San Francisco22h ago
Seniority
Lead

About the role

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}">&nbsp;</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>&nbsp;</div> <div>Led by Tassos Gianakakos, 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>&nbsp;</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>&nbsp;</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>&nbsp;</div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div>&nbsp;</div> <div>&nbsp;</div></div><p><strong>Position Title: </strong>VP Clinical Development, Tonlamarsen (TLA)</p> <p><strong>Department:&nbsp;</strong>Development</p> <p><strong>Reports To:</strong>&nbsp;Chief Medical Officer</p> <p><strong>Location:&nbsp;</strong>South San Francisco, CA&nbsp;or Princeton, NJ&nbsp;– On-site 4 days per week (Mon to Thurs)&nbsp;</p> <p>&nbsp;</p> <p>The<strong>&nbsp;VP,</strong>&nbsp;<strong>Clinical Development,&nbsp;</strong>working closely with the Global Program Head (GPH), will&nbsp;have direct responsibility as Clinical Lead for the&nbsp;Tonlamarsen&nbsp;program accountable for clinical development strategy and execution across the&nbsp;TLA&nbsp;program.&nbsp;</p> <p>The successful candidate will be a highly credible physician leader, a strong people manager, and a trusted thought partner to the GPH, CMO, CEO, and Executive Committee.&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;<strong>Key Responsibilities</strong>&nbsp;</p> <p>&nbsp;</p> <p><strong>Tonlamarsen&nbsp;Program – Clinical Lead</strong>&nbsp;</p> <ul> <li>Serve as a core member of the Global Program Team&nbsp;(GPT)&nbsp;and Clinical Lead for the TLA program,&nbsp;with&nbsp;end-to-end accountability for clinical strategy and execution, including protocol development and approval and regulatory interactions.&nbsp;</li> <li>Lead the TLA Clinical Strategy Sub-Team (CST) with cross-functional leadership in development and execution of the TLA clinical development plan.&nbsp;</li> <li>Own clinical development plans, and protocol design, with critical input for&nbsp;indication&nbsp;selection and target product profile (TPP) development for&nbsp;TLA.&nbsp;</li> <li>Lead clinical decision-making based on emerging data, benefit–risk&nbsp;assessments and&nbsp;evolving regulatory expectations.&nbsp;</li> <li>Act as the primary clinical&nbsp;development&nbsp;point of contact for regulatory interactions, investigators, and key opinion leaders related to&nbsp;TLA.&nbsp;</li> <li>Partner closely with Development Operations, Biometrics, Regulatory, and Medical Affairs to ensure seamless execution.&nbsp;</li> </ul> <p><strong>Executive &amp; External Engagement</strong>&nbsp;</p> <ul> <li>Act as a senior clinical representative in Executive Committee discussions, as&nbsp;appropriate.&nbsp;</li> <li>Present clinical strategy, progress, and risks to internal leadership and, when needed, the Board of Directors.&nbsp;</li> <li>Represent&nbsp;Kardigan&nbsp;clinical development&nbsp;externally at scientific meetings, advisory boards, and partner interactions related to&nbsp;TLA&nbsp;and as needed on other programs.&nbsp;</li> </ul> <p>&nbsp;&nbsp;</p> <p><strong>Qualifications</strong>&nbsp;</p> <ul> <li>MD (or equivalent medical degree); board certification&nbsp;strongly&nbsp;preferred.&nbsp;</li> <li>10+ years of experience in clinical development within biotechnology and/or pharmaceuticals.&nbsp;</li> <li>Demonstrated&nbsp;experience serving as clinical lead for a major program or asset, ideally through key&nbsp;late-stage&nbsp;development milestones.&nbsp;</li> <li>Strong understanding of clinical trial design, regulatory strategy, and benefit–risk assessment.&nbsp;</li> <li>Proven ability to influence and lead cross-functional teams.&nbsp;</li> <li>Experience in late-stage development and/or regulatory submissions.&nbsp;</li> <li>Prior experience managing or mentoring other MDs.&nbsp;</li> <li>Experience in a high-growth or emerging biotech environment.&nbsp;</li> <li>Track record of effective partnership with a CMO or senior medical leadership.&nbsp;</li> </ul> <p><strong>&nbsp;Leadership Characteristics</strong>&nbsp;</p> <ul> <li>Highly credible clinical development leader with strong clinical judgment.&nbsp;</li> <li>Strategic thinker who balances rigor with speed and pragmatism.&nbsp;</li> <li>Strong collaborator and people leader with extensive experience leading and building teams.&nbsp;</li> <li>Comfortable operating in ambiguity and helping design future-state organizations.&nbsp;</li> </ul> <p>&nbsp;</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>$340,000</span><span class="divider">&mdash;</span><span>$416,000 USD</span></div></div></div>

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