Senior Director, Regulatory Science Lead

Role Overview & Key Functions:The Regulatory Science Lead is responsible for advancing and applying regulatory science to all our regulatory deliverables. The incumbent will leverage his/her scientific acumen and understanding of regulatory requirements to support the Regulatory Leads and partner with cross-functional Subject Matter Experts to optimize our regulatory approach.Key ResponsibilitiesSupport the Regulatory Lead(s) to ensure the most advanced regulatory science is applied optimally to our regulatory strategies and deliverables across Karyopharm’s development programs, as assignedWorking under the direction of the Regulatory Leads and in collaboration with cross-functional Subject Matter Experts and Medical Writing, provide leadership in key regulatory submissions including INDs and Amendments, Meeting Packages, and Marketing Applications as well as responses to Health Authority Information RequestsPartner cross-functionally with Clinical Development, Biostatistics, Translational Medicine, Clinical Pharmacology, Medical Writing, and Regulatory Affairs teams to ensure the Company’s regulatory submissions are cohesive and the process is efficientIn collaboration with cross-functional Subject Matter Experts, develop scientifically rigorous arguments supporting unmet medical need, clinical benefit, and benefit-risk assessments.Interpret evolving regulatory guidance, precedent approvals, and policy trends to educate internal stakeholdersCandidate Profile & Requirements:QualificationsMinimum B.S. degree in life/health/technical sciences requiredPostgraduate degree in Regulatory Affairs is a plusPrevious oncology experience highly preferredMinimum 10+ years of regulatory experience within the biotech or pharmaceutical industryMinimum of 10 years of experience preparing regulatory documentsThorough understanding of current FDA Guidance for Industry documents applicable to Karyopharm’s development programs Strong background in the preparation of regulatory submissions including INDs and Amendments, Meeting Packages, and Marketing Applications as well as responses to Health Authority Information RequestsAbility to work both independently with minimal direction to meet team goalsDemonstrate excellent communication skills, both oral and writtenStrong interpersonal skills and the ability to work effectively with cross-functional colleaguesAbility to perform research related to regulatory issuesComputer literacy is required At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $280 K - 320 K USD.Our Value Proposition:This is a uniquely exciting time to join Karyopharm Therapeutics where we are pioneering the science of nuclear export inhibition to develop differentiated therapies for patients with cancer. We are building upon an established commercial foundation in multiple myeloma while advancing the potential of selinexor across additional hematologic and solid tumor cancers including myelofibrosis and TP53 wild-type endometrial cancer, areas where patients continue to face significant unmet needs. Our lead therapy, XPOVIO (selinexor), is a first-in-class inhibitor of exportin 1 (XPO1) and is approved in the U.S. for adults with relapsed or refractory multiple myeloma, with approvals in more than 50 countries and territories outside the U.S. We are also exploring opportunities to evaluate XPO1 inhibition across myeloproliferative neoplasms and TP53 wild-type driven solid tumors using next-generation compounds, including eltanexor. As we prepare for our next phase of growth, we are continuing to invest in critical capabilities across the organization to support future opportunities and deepen our impact in oncology. We are looking for talented people who are motivated by meaningful work, energized by growth and momentum, and excited by the opportunity to help shape what comes next in a collaborative, fast-moving environment where individual contributions are visible and valued. Learn more at Karyopharm Therapeutics. Job SummaryJob ID: 2026-2446# of Openings: 1Category: Quality & Regulatory AffairsType: Regular Full-Time