VP, Head of Drug Substance Development

<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>VP, Head of CMC Drug Substance Development</p> <p>Location:  South San Francisco, CA or Princeton, NJ (preferred,) </p> <p>Onsite: 4 days/week</p> <p><strong>Role Overview</strong></p> <p>Kardigan is seeking an accomplished and forward-thinking, highly effective leader to serve as Vice President, Head of CMC Drug Substance Development. Reporting directly to the Chief Technical Operations Officer, this leader will build and oversee a best-in-class Chemical Development organization supporting a growing early-stage pipeline and a complex late-stage portfolio across small molecules and oligonucleotides.</p> <p>This role is responsible for end-to-end API development — from route design through commercial readiness — and for providing technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities.</p> <p>---</p> <p><strong>Key Responsibilities</strong></p> <p><strong>Leadership & Talent Development</strong></p> <ul> <li>Provide strong, visible leadership to the Chemical Development function.</li> <li>Build, lead, mentor, and retain a high-performing team supporting programs from early development through commercialization.</li> <li>Oversee onboarding, career development, and capability building across the organization.</li> <li>Foster a culture of scientific excellence, accountability, and collaborative problem-solving.</li> <li>Build a culture within Chem Dev that collaborates well and works effectively with others</li> <li>Support the ongoing development and growth of the Tech Ops capability within Kardigan, contribute effectively as a member of the Tech Ops LT.</li> </ul> <p>                                                                                                                                                            </p> <p><strong>Chemical & Process Development</strong></p> <ul> <li>Lead route selection, process optimization, scale-up, technology transfer, validation, and manufacturing strategy for all drug substance programs.</li> <li>Ensure processes are designed to meet quality, yield, cost, and scalability targets appropriate for each development stage.</li> <li>Develop and manage phase-appropriate plans for process development, manufacturing, and supply.</li> <li>Oversee and provide technical governance for all CDMO/CMO-executed activities.</li> </ul> <p><strong>Quality, Regulatory & Technical Documentation</strong></p> <p><u>Responsible for supervising the following activities:</u></p> <ul> <li>Batch release activities group</li> <li>Establish drug substance specifications and stability programs in partnership with Analytical, Quality, and Regulatory functions.</li> <li>Author and review CMC documentation for regulatory submissions, including protocols, reports, and Module 3 sections.</li> <li>Support investigations, deviations, and root-cause analyses to ensure robust scientific and operational outcomes.</li> </ul> <p><strong>Cross-Functional Collaboration</strong></p> <ul> <li>Partner closely with Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Supply Chain, and Legal to ensure aligned execution across the development lifecycle.</li> <li>Support inspection readiness and interactions with global health authorities.</li> <li>Work with Procurement and Legal teams to negotiate and manage contracts governing outsourced development and manufacturing.</li> </ul> <p><strong>Strategy, Planning & Risk Management</strong></p> <ul> <li>Maintain awareness of evolving regulatory expectations and state-of-the-art manufacturing technologies.</li> <li>Assess CDMO capacity, supply chain risks, and inventory vulnerabilities and present effective solutions to executive leadership.</li> <li>Lead strategic planning for drug substance sourcing, technology strategy, and long-term capability development.</li> <li>Oversee contract deliverables and ensure operational alignment with Kardigan’s business objectives.</li> </ul> <p>---</p> <p><strong>Qualifications & Preferred Experience</strong></p> <ul> <li>BS and MS/PhD in Organic Chemistry, Chemical Engineering, or a related scientific discipline</li> <li>15+ years of experience in leading the development of assets, spanning early- and late-stage development.</li> <li>Expertise in small molecule and preferably oligonucleotide process development.</li> <li>Experience in leading the development of mid Phase and late phase assets</li> <li>Demonstrated experience taking drug substances from R&D through commercialization.</li> <li>Strong knowledge of GMP, global regulatory expectations, and quality systems.</li> <li>Direct experience with global regulatory submissions (IND, IMPD, NDA, MAA).</li> <li>Proven leadership in process validation and continuous improvement initiatives.</li> <li>Excellent communication and presentation skills, with the ability to partner effectively with executive leadership and cross-functional teams.</li> <li>Ability to operate with agility in a fast-paced, matrixed, growth-oriented environment.</li> <li>Creative, solutions-focused mindset with a track record of driving operational progress and scientific excellence.</li> </ul> <p> </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>$270,000</span><span class="divider">—</span><span>$372,000 USD</span></div></div></div>