Director, Regulatory Affairs

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.Essential Job FunctionsThe Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions.Contribute to the development and implementation of regulatory strategies for assigned projects.Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.). Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.Provides strategic and technical regulatory input for key product development documents.Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.Job Specifications10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experiencePharmD/MS preferred, or Bachelors degree in life scienceExperience supporting NDAs and working on post-approval products, drug labeling experience would be greatExperience leading IND/CTA submissions for clinical trialsExcellent written and spoken communication skillsAttention to detailStrong organizational skillsStrong interpersonal skillsSolid working knowledge of drug development processExperience with planning and managing IND/CTA submissions.Experience working and interacting directly with FDA and/or other agenciesGood understanding of US and EU regulatory landscapeHematology/Oncology or orphan-drug experience are preferredDemonstrated ability to think critically and analyze scientific information while paying close attention to detailThe ability to influence and negotiate professionally at various levels within the project team and with external partnersThe base range for this role at the Director level is $226,495 - $258,817 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.Kura’s Values that are used for candidate selection and performance assessments:We work as one for patientsWe are goal-focused and deliver with excellenceWe are science-driven courageous innovatorsWe strive to bring out the best in each other and ourselvesThe Kura Package Career advancement/ development opportunitiesCompetitive comp packageBonus401K + Employer contributionsGenerous stock optionsESPP Plan20 days of PTO to start18 Holidays (Including Summer & Winter Break)Generous Benefits Package with a variety of plans available with a substantial employer matchPaid Paternity/Maternity LeaveIn-Office Catered lunchesHome Office SetupLifestyle Spending StipendCommuter Stipend (Boston Office)Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1-mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.If you are a California resident, please see the attached Privacy Notice CA Privacy Notice