Clinical Operations Director

2 weeks ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Title: Director, Clinical Operational Excellence

Deciphera Pharmaceuticals is seeking a highly skilled and experienced Director, Clinical Operational Excellence to lead our clinical operations team. As a key member of our organization, you will be responsible for driving operational excellence and quality in all clinical trials sponsored by Deciphera.

Key Responsibilities:
  • Lead the development and implementation of clinical operations strategies and processes to ensure compliance with regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams to establish risk-based quality management best practices and ensure compliant risk management processes are deployed and monitored.
  • Develop and maintain a framework for collecting clinical trial performance metrics to benchmark individual trial performance and establish comparisons against industry benchmarks.
  • Drive clinical operations innovation through the identification and implementation of new technologies, processes, and process improvement initiatives.
  • Manage the outsourcing and/or management of the eTMF for internally managed clinical trials.
Requirements:
  • Bachelor's degree in health science or related field.
  • Excellent communication, organizational, and problem-solving skills.
  • Strong attention to detail and ability to manage multiple priorities.
  • Expertise in clinical development process (Phase 1-3), global regulatory requirements, and guidelines for clinical trials.
  • Extensive CRO/vendor management experience.
  • Excellent leadership, interpersonal, communication, planning, and organizational skills.
  • Established ability to manage and resolve complex issues.
  • Strong oncology and other therapeutic area knowledge as well as global experience.
  • Minimum of 5 years in clinical trial management.
Preferred Qualifications:
  • Greater than 10 years in clinical operations and/or trial management, managing complex clinical development programs.
  • Advanced degree preferred.
What We Offer:
  • Comprehensive benefits package, including non-accrual paid time off, summer vacation bonus, global company-wide summer and winter shutdowns, annual lifestyle allowance, monthly cell phone stipend, internal rewards and recognition program, medical, dental, and vision insurance, 401(k) retirement plan with company match, life and supplemental life insurance for family, short and long-term disability insurance, health savings account with company contribution, flexible spending account for either health care and/or dependent care, family planning benefit, and generous parental leave.

Deciphera Pharmaceuticals is an equal employment opportunity employer and values diversity. We invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional and will not affect your opportunity for employment.



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