Assoc Dir/Director, Clinical Quality Assurance

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.

Reporting to the Senior Director of Quality Assurance, the Associate Director/Director, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and pharmacovigilance activities. The incumbent is also responsible for supporting relevant processes and programs ensuring appropriate computer system validation/assurance (CSV/A) activities are completed for applicable clinical systems. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance across clinical development programs and relevant departments including clinical development, trial operations, pharmacovigilance, clinical data sciences, and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.

ESSENTIAL JOB FUNCTIONS:

• Develop collaborative partnerships with clinical study teams/study team leaders to maintain a current understanding of potential areas of quality risk exposure within the context of ongoing clinical studies and across clinical programs as assigned.
• Ensure compliance with clinical quality assurance activities including facilitating and managing internal and external GCP audits/audit programs, as applicable.
• Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance
• Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
• Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues.
• Provide related training on new regulatory requirements and industry practices.
• Lead and manage clinical inspection readiness activities for assigned programs and other key programs as applicable.
• Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable.
• Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs.
• Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs.

JOB SPECIFICATIONS:

• BA/BS degree required, advanced degree a
• For Associate Director a minimum of 8 years, for Director, minimum of 10 years of experience in the bio-pharmaceutical R&D industry with at least 6 or more years in a current, hands-on GCP Quality Assurance
• Minimum 2 years of managerial experience directly leading projects, programs or directing the allocation of resources required.
• Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
• Demonstrated knowledge and application of Global regulations and guidance for GCP, GVP, and CSV/A
• Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs.
• Experience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner audits.
• Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus.
• Ability to write clear quality position statements, risk-based audit reports, and procedures.
• Excellent oral and written communication
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Operational Experience (e.g., Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage.

The base range for an Assoicate Director is $162,000 - $190,000 and a Director is $202,000 - $229,000 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 discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is 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. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). 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.