Director, Clinical Operational Excellence

Director, Clinical Operational Excellence

• Full-time
• Work Type: Full time
• Job Location: On-Site Waltham

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

The Director, Clinical Operational Excellence is responsible for leading a Center of Excellence aimed at improving the operational performance and quality of all clinical trials sponsored by Deciphera Pharmaceuticals.

The Role:

• Lead the internal Cross Functional Trial Teams in the establishment of Risk Based Quality Management best practices.
• Establish a framework for collecting clinical trial performance metrics to manage CROs and vendors.
• Drive clinical operations innovation through identification and implementation of new technologies and processes.
• Manage the eTMF for internally managed clinical trials.

What You’ll Do:

• Drive project risk analysis and develop solutions to complex problems.
• Provide advice, identify issues, analyze trends, and implement standardized quality metrics.
• Contribute to the development and implementation of operational plans ensuring consistency across teams.
• Deliver expertise in the evaluation and management of Global Contract Research Organizations (CROs).
• Compare industry benchmarking performance insights to internal metrics.
• Manage Cross Functional TMF compliance activities.
• Lead the development of best practices concerning quality and compliance.
• Maintain awareness of existing and new regulations pertaining to GCP, ICH, etc.
• Responsible for hiring, training, and mentoring trial team staff.
• Lead initiatives to make Deciphera clinical trials patient and site-centric.
• Demonstrate excitement around the Vision and Mission of Deciphera.
• Other duties as assigned.

What You’ll Bring:

• Bachelor’s degree in health science or related field.
• Excellent communication, organizational, and problem-solving skills.
• Strong attention to detail.
• Expertise in clinical development process and global regulatory requirements.
• Strong leadership and interpersonal skills.
• Minimum of 5 years in clinical trial management.
• Ability to travel approximately 20%.

Preferred Qualifications:

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

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• Monthly cell phone stipend
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Generous parental leave