VP, 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 Vice President of Clinical Operations to lead the design, execution, and oversight of Petragen’s clinical trial programs from first-in-human through pivotal registration studies. This is a senior leadership position reporting directly to the CEO, with broad responsibility for building the clinical operations function, managing CRO and vendor relationships, and ensuring that studies are executed on time, on budget, and in compliance with all applicable regulatory requirements.

The VP, Clinical Operations will be a key member of the executive team and will play a central role in shaping Petragen’s clinical development strategy, contributing to regulatory interactions, and driving the operational execution that translates our science into patient impact.

Key Responsibilities

• Lead all aspects of clinical trial operations, including study design input, protocol development support, site selection, patient enrollment strategy, monitoring, and close-out across multiple therapeutic programs
• Build, manage, and mentor the clinical operations function, including internal team members and external contract staff
• Select, negotiate with, and oversee CROs, central laboratories, imaging vendors, IRT/RTSM providers, and other clinical trial service providers
• Develop and manage clinical trial budgets, timelines, and resource plans; provide regular reporting to executive leadership and the board
• Ensure all clinical activities comply with ICH-GCP guidelines, FDA regulations, and applicable local regulatory requirements
• Oversee development and maintenance of study-level documents including monitoring plans, data management plans, and risk-based monitoring strategies
• Drive cross-functional collaboration with regulatory affairs, CMC, biostatistics, medical affairs, and translational teams to ensure seamless study execution
• Contribute to regulatory strategy and represent clinical operations in interactions with FDA and other regulatory authorities, including IND submissions, pre-IND meetings, and advisory committee preparations
• Establish and maintain clinical operations SOPs, systems, and quality standards appropriate for a growing organization
• Identify and mitigate operational risks across the clinical portfolio; implement corrective actions as needed
• Evaluate and implement clinical trial technologies including EDC, ePRO/eCOA, CTMS, and safety databases

Qualifications

• Bachelor’s degree required; advanced degree (MS, PhD, PharmD, MBA, or MD) strongly preferred
• 15+ years of progressive clinical operations experience in the pharmaceutical or biotechnology industry, with at least 5 years in a VP or senior director-level role
• Demonstrated track record of leading clinical trials from Phase I through Phase III/registration, including successful NDA/BLA submissions
• Deep expertise in CRO selection and management, vendor oversight, and clinical trial budgeting
• Thorough knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and international regulatory frameworks
• Experience with risk-based monitoring approaches and modern clinical trial technologies
• Proven ability to build and lead high-performing teams in a lean, fast-paced environment
• Strong strategic thinking with the ability to balance long-term planning with hands-on operational execution
• Excellent communication skills with experience presenting to executive leadership, boards, and regulatory agencies
• Experience in rare disease, dental/periodontal, musculoskeletal, or mineralization-related therapeutic areas is a plus

Preferred Experience

• Experience at a small or mid-size biotech where you built the clinical operations function from the ground up
• Familiarity with locally delivered therapeutics, medical devices with drug components, or combination products
• Experience with adaptive trial designs and decentralized or hybrid clinical trial models
• Prior involvement in FDA Breakthrough Therapy, Fast Track, or Rare Pediatric Disease designation programs

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.