Job Description:

Reporting to the Senior Director, Head of Clinical Operations, the Senior Clinical Project ManagerAssociate Director will contribute to the overall success of PepGen's Clinical Development of its Enhanced Delivery Oligonucleotide (EDO) technology. The Senior ManagerAssociate Director 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. This is a hybrid role with 3 days (Tu - Th) on site at our Boston location.The scope of responsibilities for this role includes all aspects of trial planning and execution, timeline oversight, and vendor management. They will be responsible for the preparation of materials, relationship management between clinical sites and vendors, identification of project risks, 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.ResponsibilitiesLead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.Support project management of the EDODM1 Phase 2 clinical studyWork closely with and manage PepGen's collaboration with the Contract Research Organization (CRO) study team and ancillary vendorsAssist with driving the critical clinical trial timelines including trial site activations, recruitment, and database lock activitiesAttend and contribute meaningfully to internal and external team meetings and teleconferencesDevelop tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data pointsContribute to development strategy and execution of oversight of clinical monitoring being conducted by the CROEnsure required study documents are submitted to the electronic trial master file (eTMF); assists with periodic audit of the eTMFManage 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 objectivesCommunicate trial status, issues, and mitigations to relevant cross-functional stakeholdersCollaborate with Data ManagementBiostatistics, Pharmacovigilance, Clinical Science, and other functions to ensure robust plans for trial level data reviewTrain internal and external team members, monitors and site staff, as neededParticipate in contract and budget negotiations with clinical sites and vendorsDevelopupdate 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 amendmentsProvide oversight of trials to ensure that safety concerns andor adverse events are identified and appropriate responses to such concerns are developed and executedReview corrective action plans at individual sites and across study, and may participate in internalexternal study related auditsPerform research site activities, site initiation visits, trainings, co-monitoring, close out visits, as neededContribute to the Clinical Operations department with the implementation of best practices and standards for trial management, including sharing lessons learnedAssist with development of Standard Operating Procedures and templates for the Clinical Development departmentRequirements (Education, Skills, Competencies)BSBARN Degree in science or a health-related field is preferredMinimum 5+ years relevant industry clinical development experience, with at least 4+ year of direct trial management experienceExperience and understanding of global clinical trial operations, including Trial Master File and clinical monitoring activitiesExperience with all aspects of trial and site startup and vendor managementFamiliarity with clinical data review and data management processes, including Data Safety Monitoring Committees: experience with database locks and interim analysesExperience in a small start-up biotech as a CTMThrives in an environment where you will be creating and developing processes and systemsComfort engaging and interacting with executive level team membersMust be willing to travel up to 10%, domestically and internationallyStrong verbal and written communication skillsAbility to deal with competing priorities, strong reasoning, detail-oriented and creative problem-solving abilityExcellent knowledge of ICH GCP and FDA regulations governing the compliant conduct of clinical trialsProficient in MS Office (Excel, PowerPoint and Word)On-site minimum TuesWedThursAbout PepGen:PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit or follow PepGen on Twitter and LinkedIn.EEO StatementPepGen 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.Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each terested applicants should apply via the PepGen Careers page & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.