- Lead 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 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 and 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
- BS/BA/RN Degree in science or a health-related field is preferred
- Minimum 5+ years relevant industry clinical development experience, with at least 4+ year of direct trial management experience
- Experience and understanding of global clinical trial operations, including Trial Master File and clinical monitoring activities
- 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: experience with database locks and interim analyses
- Experience in a small start-up biotech as a CTM
- Thrives in an environment where you will be creating and developing processes and systems
- Comfort engaging and interacting with executive level team members
- Must be willing to travel up to 10%, domestically and internationally
- Strong verbal and written communication skills
- Ability to deal with competing priorities, strong reasoning, detail-oriented and creative problem-solving ability
- Excellent knowledge of ICH GCP and FDA regulations governing the compliant conduct of clinical trials
- Proficient in MS Office (Excel, PowerPoint and Word)
- On-site minimum Tues/Wed/Thurs
- 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.
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Senior Manager/Associate Director, Clinical Project Manager - Boston, United States - PepGen
Description
Reporting to the Senior Director, Head of Clinical Operations, the Senior Clinical Project Manager/Associate Director will contribute to the overall success of PepGen's Clinical Development of its Enhanced Delivery Oligonucleotide (EDO) technology. The Senior Manager/Associate 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.
Responsibilities
Requirements (Education, Skills, Competencies)
About PepGen:
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.
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.
Interested applicants should apply via the PepGen Careers page
Recruitment & 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.
