Senior Director, 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><strong>Position Title: Sr. Director Drug Substance Development</strong></p> <p><strong>Department: Technical Operations</strong></p> <p><strong>Reports To: VP Head of DS Development</strong></p> <p> </p> <p><strong>About Us</strong></p> <p>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 being <strong>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.  </p> <p>These values are the foundation of our work, empowering us to make a real difference, every day. </p> <p> </p> <p><strong>4 day on-site M-Th</strong></p> <p><strong>Role Overview</strong></p> <p>Kardigan is seeking an experienced and accomplished Senior Director of CMC Drug Substance Development. Reporting directly to the VP of Chemical Development, this candidate will oversee the development of a growing early‑stage pipeline and a complex late‑stage portfolio across small molecules and oligonucleotides.</p> <p>This role is responsible for ensuring the  end‑to‑end API development — from route design through commercial readiness across the portfolio of small molecule candidates, — and for providing technical, strategic, and operational leadership across all internal and outsourced development and manufacturing activities, ensuring deliverables are met.</p> <p> </p> <p><strong>Key Responsibilities</strong></p> <p><strong>Chemical & Process Development</strong></p> <ul> <li>Technical lead for programs. Ensuring programs move smoothly through development from early phase to late phase, file and launch.</li> <li>Technical lead for 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> <li>Provide support and guidance to other members of the Tech Ops department</li> </ul> <p><strong>Quality, Regulatory & Technical Documentation, including</strong></p> <ul> <li>Batch release activities</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> <li>Lead technical trouble shooting activities and ensure appropriate technical solutions are implemented.</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>Support 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 the development of assets, spanning early‑ and late‑stage development.</li> <li>Expertise in small molecule and preferably oligonucleotide product 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 and work within 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> <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>$229,000</span><span class="divider">—</span><span>$298,000 USD</span></div></div></div>