Senior Clinical Project Manager

Job not on LinkedIn

🔥 26 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $138k - $168k / year

⏰ Full Time

🟠 Senior

🏥 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

• Lead the planning, execution, and delivery of assigned global clinical studies • Manage study timelines, budgets, quality, and overall operational execution • Identify and address operational risks and challenges to keep studies on track • Lead cross-functional study teams, driving collaboration, accountability, decision-making, and problem-solving • Partner with Clinical Operations, Data Management, Regulatory, Clinical Supply, and other functions • Oversee CROs and external vendors • Monitor CRO and vendor performance and ensure alignment with timelines, budgets, quality expectations, and contractual obligations • Communicate study progress, risks, and key decisions to internal stakeholders and Clinical Operations leadership • Contribute to Clinical Operations processes and ways of working that support efficient, high-quality study execution • Perform other duties and responsibilities as assigned

🎯 Requirements

• Bachelor’s degree in health science or a related field • 8+ years of clinical research experience, including meaningful responsibility for managing complex clinical trials • Strong global clinical trial and later-stage development experience, ideally including Phase III • Substantial experience leading large, complex Phase II studies will also be considered • Demonstrated ability to lead and influence cross-functional study teams • Hands-on experience managing CROs and vendors and proactively addressing operational risks • Strong working knowledge of GCP, ICH, FDA, and applicable global clinical trial requirements • Strong communication and problem-solving skills • Ability to work independently, advocate for what is needed, and recognize when to engage others for support • Preferred: Phase III global study experience • Preferred: Oncology or rare disease clinical development experience • Preferred: Experience with eTMF, EDC, IWRS, and RBQM platforms • Preferred: Experience managing clinical study budgets and contracts • Preferred: Experience within a fast-paced biotechnology environment • Preferred: PMP certification or equivalent project management training • Availability for occasional early-morning or evening meetings across time zones • Travel of approximately 25% may be required, including travel to Boston approximately twice per year and attendance at relevant conferences or study-related meetings

🏖️ Benefits

• Competitive salary and annual bonus • Long-term incentive plan • Full range of benefits and other incentive compensation plans (if applicable) • Medical, dental, and vision insurance • 401(k) retirement plan with company match • Generous parental leave • Family planning benefits • Opportunities for personal and professional growth

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