AD/Director, Clinical Data Sciences at Kura Oncology

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

245700.0

Posted On

11 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Data Sciences, Leadership, Oncology Experience, Vendor Management, Planning, Organization, Time Management, EDC Systems, Data Visualization, CDISC Standards, Communication Skills, Analytical Thinking, Attention to Detail, Regulatory Knowledge, Risk Management, Process Optimization

Industry

Biotechnology Research

Description

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 Functions: This is a leadership position working with the Clinical Trial Management and Clinical Development functions to drive program execution of data science deliverables, operational excellence, implement scalable data processes, and provide scientific and technical leadership to ensure data integrity and regulatory compliance. The role is ideal for an experienced data sciences leader who thrives in a fast-paced, hands-on environment. Serve as the accountable data sciences leader for key programs, ensuring proactive risk management and issue resolution. Develop and execute the clinical data sciences strategy to support program pipeline and portfolio goals. Oversee end-to-end data management activities from study start-up through submission, including protocol development, database design, data cleaning, and lock. Ensure timely and accurate delivery of clinical data to support interim analyses, database locks, and regulatory submissions. Ensure study documentation and filing is maintained in an inspection ready state and provide leadership and direct support as required for audits and regulatory inspections. Oversee vendor partnerships (CROs, EDC providers, and other data service partners) and ensure adherence to timelines, budgets, and quality standards. Promote a culture of quality, innovation, and collaboration across operations and development functions. Drive process optimization and digital transformation initiatives. Provide direct study support as may be required to support business objectives. Lead and mentor a high-performing clinical data sciences team. Support establishment and maintenance of data standards in accordance with industry guidelines. Complete other duties assigned by manager. Job Specifications: B.A./B.S. or MA/MBA degree in Biology, Health Sciences, or related scientific field required. 10+ years in clinical data management/sciences within the pharmaceutical or biopharma industry. Prior leadership experience managing teams and overseeing multiple studies. Oncology experience. Extensive experience in managing external vendors (CROs, central laboratories, etc). Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Demonstrated expertise in EDC systems (Veeva EDC, Medidata Rave, etc.), data visualization platforms, and CDISC standards. Excellent communication skills. Analytical thinker with a data-driven mindset and attention to detail. Knowledge of health authorities’ rules and regulations governing clinical data collection, storage, transmission, and privacy. Flexibility to travel approximately 5-10% of time. The base range for an Associate Director is $176,800 - $208,000 and Director is $223,000 - $245,700 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 patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package Career advancement/ development opportunities Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter 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

Responsibilities

Lead the Clinical Data Sciences team and oversee data management activities from study start-up through submission. Ensure timely delivery of clinical data and maintain compliance with regulatory standards.