Senior Clinical Trial Manager

Company Overview:

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.  

Prime Medicine is currently progressing a diversified portfolio of eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches. Over time, the Company intends to maximize Prime Editing’s therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases. For more information, please visit www.primemedicine.com.

Position Overview

Join and a collaborative, agile and transformative Clinical Development Operations (CDO) team by leading and contributing to transformative clinical programs for patients in rare diseases and beyond. 

Reporting to the Director of Clinical Operations, the successful candidate will be responsible for the operational execution of clinical trials within our liver directed gene therapy portfolio and will effectively lead the study start-up, implementation, and management of our studies, ensuring adherence to timelines, budget, and quality standards in support of regulatory filings. The ideal candidate must be comfortable overseeing and managing cross-functional study teams, including internal stakeholders and external vendors. 

Responsibilities

• You will oversee the day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, patient enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
• Lead a dynamic cross-functional team to ensure study deliverables are met on time and within budget guidelines, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
• Initiate and manage study-level timelines; drive study startup activities, including site feasibility and selection, regulatory submissions, and site activation.
• Participate in the development and review and provide clinical operations input into key clinical documents such as the protocol, investigator brochure, CRFs, regulatory documents, clinical study reports and other documents and plans as appropriate.
• Develop critical study documents including informed consent forms, study conduct documents such as study manuals, the Study Operations Manual, study tools, etc.
• Train team members and site staff, including vendors, as needed
• Support the identification and onboarding of new vendors, including contract and budget negotiations.
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.
• Perform and document study level sponsor oversight of outsourced clinical activities, including oversight to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Partner with clinical supply chain to help manage study level clinical supply demand
• Ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
• Develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
• Develop and maintain strong, collaborative relationships with key stakeholders within and external to Prime Medicine.
• Participate in clinical operations workstreams and SOP development for critical department initiatives.
• Assist with the onboarding and mentoring of new or junior clinical operations associates; support oversight and management of consultants.

Qualifications:

• BS/BA/RN Degree in science or a health-related field is preferred
• Minimum 7 years relevant industry clinical development experience, with 2+ years of independent trial management preferred. Sponsor experience is strongly preferred.
• Experience and understanding of drug development and global clinical trial operations
• Pivotal clinical trial oversight, or closely relevant experience required, and gene therapy experience preferred.
• Experience with all aspects of trial and site startup, CRO, vendor and laboratory management
• Familiarity with clinical data review and data management processes, including Data Monitoring Committees
• Must be able to travel up to 25%, domestically and internationally
• Creative problem-solver with excellent verbal and written communication skills
• Strong interpersonal and organizational skills, with a high degree of attention to detail.
• Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential
• Ability to lead a cross-functional team, with the potential to lead multiple projects; be willing to work with tight timelines and to multi-task in a fast-paced environment with changing priorities with a sense of urgency
• Excellent knowledge of GCP, ICH and FDA regulations; working knowledge of international regulations in the EU preferred
• “Do-what-it-takes” approach to problem solving and prospective thinking.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Positive, outgoing and collaborative attitude with a passion for helping patients using innovative science
• Be ready to embrace the principles of the Prime culture

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.