Director, Clinical Operations

Job not on LinkedIn

🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $216k - $263k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Provide strategic and operational leadership across multiple clinical programs and studies • Translate clinical development strategy into operational execution • Ensure programs are delivered with quality and accountability across timelines, budgets, and external partnerships • Initially oversee approximately two clinical programs • Lead and develop a small Clinical Operations team • Oversee clinical trial planning and execution, including timelines, budgets, quality, resourcing, operational risks, and key metrics • Provide oversight of contractors and external resources • Partner with Clinical Development, Regulatory, Data Management, Safety, and other functions • Lead CRO and vendor relationships, ensuring performance, financial accountability, quality, and delivery • Communicate program status, risks, and recommendations to senior and executive leadership • Contribute to regulatory documentation and ensure clinical deliverables support submission requirements and global regulatory expectations • Perform other duties and responsibilities as assigned

🎯 Requirements

• Bachelor’s or Master’s degree in health science or a related field • 12+ years of clinical research experience, including at least 10 years in clinical trial management and Clinical Operations leadership • Demonstrated ownership of multiple clinical programs and experience overseeing several clinical trials concurrently • Significant experience leading complex clinical trials with accountability for timelines, budgets, quality, and operational delivery • Strong CRO and vendor management experience, including performance oversight, financial accountability, risk management, and issue escalation • Demonstrated experience leading and developing Clinical Operations team members • Ability to communicate effectively with senior and executive leadership and work across functions and geographies • Strong knowledge of GCP, ICH, FDA, and global clinical development requirements • Experience supporting global clinical programs, including collaboration with teams and partners in Japan • Oncology or rare disease clinical development experience • Experience with eTMF, EDC, IWRS, and RBQM platforms • Strong clinical program and study budget management experience • Experience working within a small-to-midsize biotechnology organization • Willingness to accommodate occasional early-morning or evening meetings with global colleagues • Willingness to travel for program activities, internal meetings, and industry conferences

🏖️ Benefits

• Competitive salary and annual bonus • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more • Generous parental leave and family planning benefits • Outstanding culture and opportunities for personal and professional growth • Long-term incentive plan • Full range of benefits and other incentive compensation plans (if applicable)

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