Senior Manager/Associate Director, Clinical Operations

🕒 May 8

☕ Washington – Remote

☕ Washington – Remote

💵 $160k - $217k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Outpace Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💰 $25M Series A on 2023-03

Biotechnology • Artificial Intelligence • Healthcare Insurance

Outpace Bio is a biotechnology company revolutionizing cell therapy through advanced protein design. The company is focused on curing solid tumors by programming cells to make better decisions inside the body, enhancing immune responses and maximizing the potency, specificity, and safety of cell therapies. Outpace Bio uses AI-powered protein design to create new proteins and guide engineered cells in recognizing and eliminating cancer. Its platform technologies, such as OUTSMART™, OUTLAST™, and CO-LOCKR™, aim to solve the complex mechanisms that hinder effective cancer treatment. The company aspires to create curative cell therapy products that can address a wide range of cancer indications, leveraging a deep understanding of biology and technology.

📋 Description

• Responsible for all operational aspects of assigned cell-therapy clinical trial(s) from setup through final report. • Ensure assigned trials are executed with quality, compliance, and efficiency, in accordance with regulations, timelines, and budget. • Coordinate the activities of several other clinical team members (e.g., CRAs, CTAs, Logistics, etc.). • Oversee CROs, vendors, and consultants.

🎯 Requirements

• Bachelor’s Degree or ex-US equivalent required. • Minimum of 8 years of experience in the clinical research industry, including a minimum of 5 years of trial management experience. • Robust oncology experience required including early-stage experience and cell or gene therapy (highly complex such as CAR-T). • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of trial timelines and enable a well-run trial. • Excellent organizational and time management skills, strong attention to detail. • Ability to work independently and thrive in a fast-paced evolving environment. • Good understanding of FDA and ICH GCP guidelines. • Excellent verbal and written communication skills.

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Disability insurance • Flexible spending account • Health savings account • Commuter benefits • Legal benefits • 401k plan with employer match • Stock option grants • Performance bonus • Flexible PTO • Paid sick leave • Fifteen paid holidays • Winter shutdown • Generous paid parental leave policy