[Hiring] Senior Director, Clinical Operations @Parabilis Medicines

Role Description

The Senior Director, Clinical Operations will provide strategic and operational leadership across multiple clinical trials or a full clinical program, ensuring trials are conducted in accordance with protocols, SOPs, GCP, and departmental and corporate goals. This role sets clinical operations strategy for their assigned program(s) or indications, leads and develops a team of clinical operations professionals, and provides senior-level leadership and input to ensure GCP compliant delivery of cross-functional activities.

This individual will collaborate closely with the Senior Director Operational Excellence to ensure clear direction to CROs and other vendors, and represent Clinical Operations in cross-functional governance forums.

• Accountable for delivery of assigned clinical program(s)/trials (or indications) - budget, timelines, resourcing, and quality.
• Lead and oversee execution of all trial phases based on stage of development, in compliance with ICH/GCP, local regulations, and Parabilis procedures.
• Provide senior-level leadership and oversight to the cross-functional team and CRO/vendor(s).
• Represent the Clinical Operations function in discussions with potential partners or collaborative studies.
• Provide senior clinical operations input into regulatory documents.
• Ensure study- and program-level Sponsor Oversight of outsourced clinical activities.
• Communicate program status, cost, risk, and issues to senior management.
• Provide significant input on the creation, review, training, and maintenance of departmental and organizational SOPs.
• Provide managerial oversight, mentorship, and career development for assigned clinical operations staff.
• Drive trial and site level performance and engagement through clear expectation setting and remediation planning.
• Own program/trial budget management, reporting, and forecasting.
• Represent Clinical Operations in cross-functional and senior leadership governance forums.

Qualifications

• S./B.A. in life science or related field; advanced degree preferred.
• 12+ years of clinical operations experience in biotechnology, pharmaceutical, and/or CRO industry.
• Phase 1-3 global trial management experience, preferably in Oncology or complex GI malignancies.
• Direct experience overseeing global CROs in both fully and partially outsourced models.
• Direct line management experience, including managing managers/senior individual contributors.
• Ability to lead complex or multiple programs with minimal supervision.
• Strong interpersonal and communication skills (written and oral).
• Self-motivated and adaptable in a dynamic, nimble, start-up environment.
• Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT, and EDC platforms.
• Willingness to travel (up to 30%).

Requirements

• Demonstrated use of AI tools in your current role is required.
• Previous demonstration of Health Authority interactions, interviews, and inspections.

Benefits

• Base salary range of $255,000-$290,000 per year, depending on experience and qualifications.
• Annual target bonus and equity.
• Comprehensive suite of competitive benefits designed to support overall well-being.

Core Values

• Growth-Minded: Curious, humble, and adaptable.
• In(ter)dependent: Collaborative team dynamics.
• Patient-focused: Focused on patient outcomes and scientific impact.
• All-In: Committed to solving scientific challenges.