Senior / Clinical Project Manager

Reporting to the Director of Clinical Operations, the Sr/Clinical Project Manager will contribute to the overall success of PepGen’s Clinical Development of its Enhanced Delivery Oligonucleotide (EDO) technology. The Sr/Clinical Project Manager will work closely with the Clinical Operations team to help shape the development of PepGen’s two lead clinical candidates, PGN-EDO51 and PGN-EDODM1.  This is a unique opportunity to work closely with an experienced, fast-paced team interested in providing mentorship and opportunities to experience new aspects of Clinical Development.

The scope of responsibilities for this role includes all aspects of trial planning and execution, timeline oversight, and vendor management. The incumbent will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. As well as manage trials to the highest quality to ensure inspection readiness, timely and robust data collection, and assist the medical monitoring team with the maintenance of subject safety. 

Responsibilities

• Independently lead activities for the EDO51 Phase 2 study with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally
• Work closely with the Director of Clinical Operations to manage the PepGen Duchenne muscular dystrophy EDO51 program
• Support project management of the EDODM1 Phase 1 clinical study
• Work closely with and manage PepGen’s collaboration with the Contract Research Organization (CRO) study team and ancillary vendors
• Assist with driving the critical clinical trial timelines including trial site activations, recruitment, and database lock activities
• Attend and contribute meaningfully to internal and external team meetings/teleconferences
• Develop tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
• Contribute to development strategy and execution of oversight of clinical monitoring being conducted by the CRO
• Ensure required study documents are submitted to the electronic trial master file (eTMF); assists with periodic audit of the eTMF
• Manage trial timelines and assist in invoice and budget review and trial spend forecasting
• Work with study team to determine patient recruitment strategies and operational feasibility and implementation of study objectives
• Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders
• Collaborate with Data Management/Biostatistics, Pharmacovigilance, Clinical Science, and other functions to ensure robust plans for trial level data review
• Train internal and external team members, monitors and site staff, as needed
• Participate in contract and budget negotiations with clinical sites and vendors
• Develop/update critical study documents as needed, including informed consent forms, study conduct documents such as study manuals, study tools, etc.; participate in development of protocols and investigator brochures, including updates and amendments
• Provide oversight of trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
• Review corrective action plans at individual sites and across study, and may participate in internal/external study related audits
• Perform research site activities, site initiation visits, trainings, co-monitoring, close out visits, as needed
• Contribute to the Clinical Operations department with the implementation of best practices and standards for trial management, including sharing lessons learned
• Assist with development of Standard Operating Procedures and templates for the Clinical Development department

Requirements 

• BS/BA/RN Degree in science or a health-related field is preferred
• Minimum 5 years relevant industry clinical development experience, with at least 2 years of direct trial management experience
• Experience and understanding of global clinical trial operations
• Experience with all aspects of trial and site startup and vendor management
• Familiarity with clinical data review and data management processes, including Data Safety Monitoring Committees
• Must be willing to travel up to 20%, domestically and internationally
• Strong verbal and written communication skills
• Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential
• Ability to work on teams with aggressive timelines and to multi-task in a fast-paced environment with changing priorities
• Excellent knowledge of ICH GCP and FDA regulations governing the compliant conduct of clinical trials
• Independently motivated to learn and lead
• 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
• Proficient in MS Office (Excel, PowerPoint and Word)

About PepGen

We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts.

EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.  

Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by PepGen Human Resources.

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.