Vice President, Clinical Development, Tonlamarsen (TLA) at Kardigan

Princeton, New Jersey, United StatesFull-timeClinical DevelopmentPosted 5 months ago

About the Role

<div class="content-intro">About Us  <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. </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 Gianakakos, Jay Edelberg, M.D., Ph.D., 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. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—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 eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible 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> Job Overview  Kardigan is seeking a Vice President, Clinical Development to serve as the Clinical Development Lead (CDL) for our Tonlamarsen (TLA) program, with end-to-end accountability for clinical development strategy and execution. Reporting to the Head of Clinical Development — currently the Chief Development Officer on an interim basis — this physician leader will be a strong people manager and a trusted thought partner to the Global Program Team, fellow VP Clinical Development Leads, the Chief Medical Officer, the CEO, and Executive Committee members.  This is a hands-on clinical development leadership role. The Vice President owns the Clinical Development Plan, leads the design of the clinical protocol,  provides matrix leadership for the cross-functional program team, direct management of the Clinical Development Medical Director(s) and Clinical Scientist(s), and brings deep biotech clinical development experience to a fast-moving late-stage program.  Essential Duties and Responsibilities  Program Clinical Leadership  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Serve as the Clinical Development Lead for the Tonlamarsen program, with end-to-end accountability for clinical development strategy and execution. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Own the Clinical Development Plan (CDP) and the clinical program strategy, ensuring alignment with the overall program strategy set by the Global Program Team (GPT) and with Kardigan’s wider development goals. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Co-lead the Global Clinical Team (GCT) and serve as a core member of the GPT, representing the clinical program in governance forums and ensuring cross-functional alignment on clinical priorities, timelines, and decisions. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Own the clinical protocol as a program deliverable and lead protocol design, with critical input into indication selection and Target Product Profile (TPP) development. The Clinical Development Medical Director owns the scientific and clinical content of the protocol; the Clinical Scientist leads drafting and amendment activities. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Hold accountability for clinical program-level execution, budget, and timelines, in partnership with the Clin Ops Program Lead, who owns operational budget build and roll-up. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Lead clinical decision-making based on emerging data, benefit–risk assessments, and evolving regulatory expectations, partnering closely with the Statistics Program Lead on pre-specified go/no-go criteria and success thresholds, recommending go/no-go decisions and ensuring patient safety remains the foremost consideration. Partner with Drug Safety & Pharmacovigilance on ongoing safety surveillance, signal evaluation, and benefit–risk communication for the program, and provide medical oversight of medical monitoring activities. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Partner closely with colleagues from Clinical Operations, Biometrics, Regulatory Affairs, and Medical Affairs to ensure seamless oversight and execution of clinical trials across the program. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Support Medical Affairs on publication planning, congress presentations, and scientific communication of clinical data, ensuring accuracy and scientific integrity. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Where the program involves an in-licensing or alliance partner, lead the clinical dimensions of the alliance relationship. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Ensure clinical development activities are conducted in accordance with Good Clinical Practice, applicable regulations, and Kardigan policies and SOPs, upholding the highest standards of patient safety, ethics, and scientific integrity. </li> </ul> People Leadership  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Line manage the Clinical Development Medical Director and the Clinical Scientist for the program; accountable for performance, development, day-to-day prioritization, and ensuring resources are managed appropriately across the program. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Recruit, manage, mentor, and develop clinical development physicians and scientists as the program team grows. Depending on the program, the Medical Director role may be open at the point of hire, and the CDL should expect to lead that search. </li> </ul> Regulatory, Executive & External Engagement  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1">Act as the primary clinical development point of contact for regulatory interactions, and provide clinical leadership for health authority meetings and submission content in partnership with Regulatory Affairs. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1">Present clinical strategy, study progress, and risks to internal leadership and, when needed, to the Kardigan Executive Committee and Board of Directors, with clear, balanced framing of data and uncertainties. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1">Identify and build relationships with key opinion leaders, academic institutions, and investigators — informing development strategy, shaping trial design, and supporting site selection and advisory board engagement. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1">Represent the Kardigan clinical development function externally at scientific meetings, advisory boards, and interactions with key opinion leaders related to the program — and potentially for other Kardigan programs — ensuring all external scientific exchange is accurate, balanced, and compliant with applicable regulations and industry codes. </li> </ul>   Qualifications and Preferred Skills  Experience  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1">MD (or equivalent medical degree) required; board certification and clinical practice experience are a plus. Cardiology or cardiometabolic specialization is welcome but not required — the ability to rapidly build deep disease-area expertise is what matters. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1">10 - 15+ years of clinical development experience within biotechnology and/or pharmaceutical companies, including substantial hands-on experience in biotech or emerging-company settings where clinical development leaders operate close to the work. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Substantial Phase 2b and Phase 3 experience, including designing and leading late-stage and/or registrational studies through execution and data readout. Experience taking a program through Phase 3 to registration/NDA is strongly preferred. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="20" data-aria-level="1">Demonstrated experience serving as clinical lead for a major drug program or asset, ideally through key late-stage development milestones. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="21" data-aria-level="1">Demonstrated strength in protocol development, including hands-on authorship of clinical protocols and amendments from concept through approval — not solely oversight of protocols written by others. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="22" data-aria-level="1">Proven experience recruiting, managing, mentoring, and developing clinical development physicians and scientists. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="23" data-aria-level="1">Experience in a high-growth or emerging biotech environment, and a track record of effective partnership with a CMO or senior medical leadership. </li> </ul> Core Competencies  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="24" data-aria-level="1">Matrix leadership. Proven ability to lead cross-functional teams across clinical, regulatory, biometrics, data management, and clinical operations, driving alignment on a unified development plan while safeguarding scientific and analytical integrity. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="25" data-aria-level="1">Strategic leadership on clinical development planning. Proven leadership in managing a cross-functional, matrixed team to develop and implement a program-wide clinical development plan, including scenario planning, assessment of clinical trial design scenarios for commercial/medical launch strategy and therapeutic adoption, partnership with Biometrics on evidence generation strategy, and partnership with Clinical Operations on operational strategy. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="26" data-aria-level="1">Drug development expertise. Deep end-to-end development experience, including phase-appropriate study design, dose and population selection, endpoint strategy, and a clear understanding of the evidentiary requirements for regulatory approval. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="27" data-aria-level="1">Regulatory strategy. Demonstrated success developing and defending regulatory strategy, including preparation of evidence packages and translation of Health Authority feedback into concrete design decisions on endpoints, multiplicity, and analysis populations. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="28" data-aria-level="1">Decision-making rigor. Experience establishing pre-specified go/no-go criteria and success thresholds prior to data availability, with a working command of the distinction between statistical significance and clinically meaningful effect. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="29" data-aria-level="1">Scientific and statistical fluency. Experienced in statistical concepts and trial designs — including estimands, interim analyses, and sources of bias — with sufficient therapeutic-area and patient-population knowledge to critically evaluate emerging data, identify anomalies, and translate clinical findings into program decisions. </li> </ul> Other  <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="30" data-aria-level="1">Strong patient-centric orientation and commitment to ensuring clinical development strategies ultimately serve patients and their families. </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":431,"335559991":259,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="31" data-aria-level="1">Ability to work on-site four days per week in Princeton, New Jersey; flexibility to travel as needed for scientific meetings, investigator engagement, and health authority interactions. </li> </ul>  <div class="content-pay-transparency"><div class="pay-input"><div class="description">Exact Compensation may vary based on skills, experience and location.</div><div class="title">Pay range</div><div class="pay-range">$340,000—$416,000 USD</div></div></div>

About the Role

Related Roles