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Senior Manager, Clinical Quality AssuranceKura Oncology, Inc. • United States
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Senior Manager, Clinical Quality Assurance

Kura Oncology, Inc.
  • US
    United States
  • US
    United States
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À propos

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:
Reporting to the Executive Director of Quality Assurance, the Senior Manager, 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. 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.
Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs.
Ensure compliance with clinical quality assurance activities including facilitating and supporting internal and external GCP audits/audit programs, as applicable.
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.
Support 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.
Job Specifications:
BA/BS degree required, advanced degree a pllus
A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level GCP Quality Assurance
Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus).
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.
Excellent oral and written communication
Ability 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.
Exercises independent judgement in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross functional decisions.
Serves as a key point of contact for cross-functional partners within their area; ensuring alignment and proactively addressing coordination needs to support tea deliverables.
The base range for this role at a Senior Manager level is $160,000 - $187,000. 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.
#LI-RM1 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 commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.
Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.
Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. 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.
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  • United States

Compétences linguistiques

  • English
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