Director, Clinical Operations

About Petragen

Petragen is a clinical-stage biopharmaceutical company developing disease-modifying therapeutics targeting ENPP1-linked mineralization biology. Our pipeline spans periodontal disease, hypophosphatasia, and calcium pyrophosphate disease. We are a small, high-ownership team that operates at the intersection of translational biology, drug development, and clinical strategy.

The Role

We are seeking a Director of Clinical Operations to drive the day-to-day planning and execution of Petragen’s clinical studies. This role will serve as the operational backbone of our clinical programs, managing CRO performance, ensuring site-level quality, tracking enrollment and timelines, and coordinating across functions to keep studies on track. The Director will work closely with the VP of Clinical Operations and cross-functional leadership to translate development plans into executed, high-quality clinical trials.

This is an opportunity for a hands-on clinical operations leader who thrives in a lean environment, is comfortable owning end-to-end trial execution, and wants to make a direct impact on programs that are advancing toward the clinic.

Key Responsibilities

• Manage the day-to-day execution of clinical trials, including CRO oversight, site management, enrollment tracking, data quality review, and issue resolution
• Serve as the primary operational point of contact for CROs and key vendors; lead regular status meetings, review deliverables, and ensure contractual and timeline adherence
• Develop and maintain study timelines, enrollment projections, risk registers, and operational dashboards; escalate risks and propose mitigation plans proactively
• Contribute to protocol development, informed consent form design, and case report form development in collaboration with medical and regulatory teams
• Oversee site feasibility assessments, site selection, site initiation visits, and ongoing site performance monitoring
• Ensure all clinical trial activities are conducted in accordance with ICH-GCP, FDA regulations, IRB/IEC requirements, and internal SOPs
• Manage clinical trial budgets at the study level; review invoices, track expenditures against forecasts, and support reforecasting as needed
• Coordinate with data management, biostatistics, pharmacovigilance, and regulatory affairs to support database locks, safety reporting, and submission-ready deliverables
• Oversee implementation and day-to-day management of clinical trial systems including EDC, IRT/RTSM, eTMF, CTMS, and ePRO platforms
• Support inspection readiness activities, including TMF quality reviews, audit preparation, and corrective action tracking
• Manage and mentor clinical operations staff, including CRAs and clinical trial associates as the team grows

Qualifications

• Bachelor’s degree required; advanced degree (MS, MBA, PharmD, or PhD) preferred
• 10+ years of clinical operations experience in the pharmaceutical or biotechnology industry, with at least 3 years in a director-level or senior manager role
• Demonstrated experience managing Phase I through Phase III clinical trials, including direct CRO and vendor oversight
• Strong working knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and clinical trial regulatory submissions
• Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC), and eTMF platforms
• Experience with risk-based monitoring frameworks and remote/hybrid monitoring approaches
• Exceptional organizational skills with the ability to manage multiple studies and competing priorities simultaneously
• Strong interpersonal and communication skills; able to work effectively with internal teams, investigators, and external partners
• Self-directed and resourceful, with a track record of delivering results in small-team or startup environments
• Experience in rare disease, dental/periodontal, musculoskeletal, or mineralization-related therapeutic areas is a plus

Preferred Experience

• Prior experience at a small or emerging biotech where you owned study execution with limited internal infrastructure
• Familiarity with locally delivered therapeutics, dental or periodontal clinical trials, or combination product development
• Experience supporting IND-enabling activities and first-in-human study readiness
• Hands-on experience with adaptive trial designs or platform trial approaches

Compensation

Compensation for this role is highly competitive and commensurate with experience, including base salary, performance-based bonus, equity participation, and a comprehensive benefits package.