Director, Clinical Operational Excellence
10 hours ago
- 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
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