Director/Sr. Director, Clinical Quality Assurance

April 10

Kura Oncology, Inc.

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Our mission is to realize the promise of precision medicines to help patients with cancer lead better, longer lives.

Oncology • Precision Medicine • Targeted Therapeutics • Biomarkers • Solid Tumors

51 - 200

💰 $125M Post-IPO Debt on 2022-11

Description

• Responsible for the development and implementation of processes and programs that provide quality and compliance oversight for clinical development programs and pharmacovigilance activities • Manage clinical internal and external audit programs • Implement QA activities to ensure compliance and data integrity • Represent clinical quality expertise and communicate regulatory requirements • Develop and lead program for issue resolution and preventive action • Collaborate with cross-functional departments and promote quality and risk management principles • Develop quality metrics and provide data and information to inform leadership

Requirements

• BA/BS degree required, advanced degree a plus • Minimum 10 years of experience in bio-pharmaceutical R&D • Minimum 4-6 years of hands-on GCP Quality Assurance experience for Director/Sr. Director level • Minimum 2 years of managerial experience • Experience with drafting, implementing, and optimizing SOPs • Knowledge of ICH regulations and guidance for GCP, GVP, and CSV/A activities • Experience with audits, root cause analysis, and corrective action plans • Ability to write clear quality position statements and reports • Strong oral and written communication skills • Strong judgment, project management, and decision-making skills

Benefits

• Competitive base salary • Comprehensive benefits package including health, dental, and vision coverage • Participation in equity programs • Annual performance-based bonus potential • Generous Paid Time Off (PTO) policy including vacation and sick days