Director of Clinical Operations

Deciphera Pharmaceuticals, Inc.Waltham

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

Required Qualifications:Bachelor’s or Master’s degree in health science or a related field. A minimum of 12 years of clinical research experience, including at least 10 years in clinical trial management and operational leadership roles. A thorough understanding of clinical development processes, GCP, ICH, and global regulatory requirements. Demonstrated ability to lead cross-functional teams and efficiently manage external CROs and vendors. Outstanding leadership, communication, and organizational skills. Strong strategic thinking and problem-solving capabilities with a focus on operational excellence. Proven success in managing global clinical programs in a small-to-midsize biotechnology setting. Experience specifically in Phase III clinical trials and a proven track record of global engagement. Preferred Qualifications:Experience in clinical programs related to oncology or rare diseases is preferred.

About the job

The Director of Clinical Operations plays a pivotal role in ensuring that clinical stage programs meet both strategic and operational objectives in compliance with set timelines, budgets, and quality standards. This leadership position is vital in guiding the Clinical Operations team, shaping clinical program strategies, and fostering collaboration and transparency across multiple functions. The Director will work closely with both internal stakeholders and external partners to facilitate high-quality clinical trial execution within the dynamic landscape of a small-to-midsize biotech organization.

Key Responsibilities:

Program Strategy & Leadership (35%)
- Formulate and implement clinical program strategies that are aligned with corporate objectives. Lead the Clinical Operations team to optimize the allocation of resources across various programs.
Clinical Trial Oversight (25%)
- Ensure that clinical trials are meticulously defined, planned, and executed in accordance with GCP, ICH, and FDA regulations. Monitor study timelines, budgets, and quality metrics to drive operational excellence.
Regulatory & Documentation Support (15%)
- Assist in drafting key regulatory documents, ensuring that clinical program outputs meet submission requirements and regulatory standards.
Vendor & CRO Management (15%)
- Oversee and manage Contract Research Organizations (CROs), vendors, and external partners to ensure that performance, deliverables, and financial accountability align with expectations.
Team Development & Collaboration (10%)
- Cultivate a collaborative environment within Clinical Operations and exemplify leadership values. Encourage transparent communication, accountability, and operational discipline across the department.
Other duties as assigned.

About Deciphera Pharmaceuticals, Inc.

Deciphera Pharmaceuticals, Inc. is an innovative biotechnology company committed to advancing treatments for patients with difficult-to-treat cancers. We leverage our proprietary drug discovery platform to develop novel therapies that significantly improve the lives of patients worldwide.

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