Senior Clinical Program Manager
1 week ago
PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies. Our Enhanced Delivery Oligonucleotide (EDO) platform leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. We are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases.
We are looking for a Senior Clinical Project Manager to join our team. In this role, you will be responsible for leading our clinical operations team and managing our myotonic dystrophy (DM1) Phase 2 clinical study. The ideal candidate will have at least 5+ years of experience in clinical development, with a strong background in trial management.
Key Responsibilities:
- Lead the cross-functional study team for the DM1 Phase 2 study, both internally and externally
- Support project management of other DM1 clinical studies
- Manage Contract Research Organization (CRO) study teams and clinical vendors
- Owning critical clinical trial timelines and budget
Requirements:
- Minimum 5+ years relevant industry clinical development experience, with at least 4+ years of direct trial management experience
- Experience with global clinical trial operations, database locks, and interim analyses in a small start-up biotech environment
- Strong understanding of ICH GCP and FDA regulations governing clinical trials
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. Additionally, we provide a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan. If you are a motivated and detail-oriented individual who thrives in a fast-paced environment, please apply for this exciting opportunity.
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