PepGen is at an exciting time in our development. We are growing our experienced, high-functioning clinical operations team and are looking for a collaborative, engaging team member with a one-team mentality. We pride ourselves on our flexibility and can-do attitude while seamlessly operating in a fast-paced, small biotech environment.
As an integral and critical member of the PepGen Team, you will lead and manage our myotonic dystrophy (DM1) Phase 2 clinical study, including managing our CRO and vendors, leading the PepGen cross-functional study team, and owning the study timelines and budget. This is a great opportunity for someone who is looking for the visibility and growth potential found at a small biotech, who can efficiently facilitate team discussion and timely decision-making, and who can be both detail-oriented and action-oriented. We are a small team and value open proactive communication, agility and creative problem-solving.
In addition to being the project manager for the DM1 Phase 2 study, you will also be supporting the team with the other DM1 studies as needed. You may also support other clinical operations activities, such as process development and optimization. We are all in the office every Tuesday-Thursday.
Responsibilities:
- Lead the cross functional study team for the DM1 Phase 2 study, both internally and externally
- Support project management of the other DM1 clinical studies
- Work closely with and manage the Contract Research Organization (CRO) study team and clinical vendors
- Own the critical clinical trial timelines (including trial site activations, recruitment, and database lock activities) and budget (including invoice and budget reviews and trial spend forecasting)
- Attend and contribute meaningfully to internal and external team meetings and teleconferences
- Ensure required study documents are submitted to the electronic trial master file (eTMF); assists with periodic audit of the eTMF
- 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
- Participate in contract and budget negotiations with clinical sites and vendors
- Develop/update critical study plans and documents, including informed consent forms, study manuals, study tools, etc.; participate in development of protocols, including updates and amendments
- Attend and assist with 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 Operations department
Requirements (Education, Skills, Competencies):
- 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 experience with database locks and interim analyses, in a small start-up biotech environment
- Experience with all aspects of trial and site startup and vendor management
- Comfortable engaging and interacting with executive level team members
- Must be willing to travel up to 20%, domestically and internationally
- Excellent communication and relationship-building skills, with both internal and external stakeholders
- Thrives in a start-up environment with competing priorities
- Strong reasoning, time and process management, 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, Word, and Project)
- On-site minimum Tues/Wed/Thurs
- Champion of a “One Team” mentality
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.
About 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 www.pepgen.com or follow PepGen on Twitter and LinkedIn.
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. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you.
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