Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp Director of Clinical Quality Assurance eager to make an impact within a mission-driven organization. 

The Director of Clinical Quality Assurance will participate in continuous improvement of the quality system framework at Science 37 by implementing various programs including quality management review, clinical data quality plans, vendor management etc. This position provides daily, quality oversight of the conduct of clinical trials at Science 37. This position is responsible for developing data monitoring plans for individual trials, overseeing vendor selection and qualification etc. This position reports to the Vice President Quality and Compliance.

• Proactively identify and implement continuous improvement opportunities and initiatives.
• Assist with development and refinement of SOPs governing clinical operations and quality operations.
• Lead effort to identify and implement an electronic quality management system.
• Collaborate extensively with clinical operations to implement various quality initiatives according to a roadmap.
• Lead efforts for equipment qualification.
• Lead deviation investigations.
• Participate in regulatory inspection preparations, and execution of inspections, including running the “war room”.
• Participate in sponsor audits.
• Conduct and participate in internal audits of Science 37 operations.
• Remain abreast of current regulations and industry best practices in clinical trials.

• Bachelor’s Degree in science, engineering or other related field required
• 10-15 years of experience in quality and compliance in clinical research, biotechnology or other GxP environment
• Proven track record of cross functional collaboration
• Extensive knowledge of cGXP regulations and current industry best practices
• Excellent written and oral communication skills
• Ability to meet deadlines in a fast paced environment
• Ability to perform risk assessments, formally and informally and recommend risk mitigation plans

• Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach.
• Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various project and changing priorities.
• Strong creative problem solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• Ability to provide guidance and structure while encouraging innovation.
• Ability to tactically implement a strategic vision.

• Ability to communicate in English (both verbal and written)

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!