Deciphera Pharmaceuticals - Waltham, MA

posted 2 months ago

Full-time - Senior
Waltham, MA
Chemical Manufacturing

About the position

The Director, Clinical Operational Excellence at Deciphera Pharmaceuticals is responsible for leading a Center of Excellence focused on enhancing the operational performance and quality of clinical trials. This role involves establishing best practices for risk-based quality management, developing performance metrics for clinical trials, and driving innovation in clinical operations through new technologies and process improvements. The Director will also oversee the management of external vendors and ensure compliance with regulatory standards while fostering a patient-centric approach in clinical trial design.

Responsibilities

  • Lead internal Cross Functional Trial Teams to establish Risk Based Quality Management best practices.
  • Ensure compliant risk management practices are deployed and monitored across all functions.
  • Establish a framework for collecting clinical trial performance metrics for management of CROs and vendors.
  • Drive clinical operations innovation through identification and implementation of new technologies and processes.
  • Manage the outsourcing and/or management of the eTMF for internally managed clinical trials.
  • Conduct project risk analysis and develop solutions to complex problems.
  • Ensure Clinical Trial Teams proactively identify and manage risks using risk identification and monitoring techniques.
  • Provide advice and implement standardized quality metrics and compliance measures for trial teams.
  • Contribute to the development and implementation of operational plans for clinical trials.
  • Deliver expertise and strategic leadership in the evaluation and management of Global CROs and vendors.
  • Compare industry benchmarks with internal metrics to monitor and improve clinical trial performance.
  • Manage TMF compliance activities and support inspection readiness.
  • Lead the development and implementation of best practices for quality and compliance in clinical trials.
  • Maintain awareness of regulations and guidance related to GCP, ICH, and data integrity.
  • Responsible for hiring, training, and mentoring trial team staff.
  • Implement a culture of patient and site-centric clinical trials.

Requirements

  • Bachelor's degree in health science or related field.
  • Minimum of 5 years in clinical trial management.
  • Expertise in clinical development process (Phase 1-3) and global regulatory requirements.
  • Extensive CRO/vendor management experience.
  • Strong leadership, interpersonal, communication, planning, and organizational skills.
  • Established ability to manage and resolve issues effectively.
  • Strong oncology and therapeutic area knowledge with global experience.
  • Excellent communication (oral and written), organizational, and problem-solving skills.
  • Strong attention to detail and proficiency in Microsoft Office.

Nice-to-haves

  • Greater than 10 years in clinical operations and/or trial management.
  • Advanced degree preferred.

Benefits

  • 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 health care and/or dependent care
  • Family planning benefit
  • Generous parental leave
  • Car allowance
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