VP, Clinical Operations

Overview

Lead clinical operations strategy for an innovative biotechnology organization advancing biologic therapies for immune-mediated diseases.
You will guide programs from preclinical development through first-in-human studies and proof of concept.
This executive opportunity offers the chance to shape a growing clinical operations function, influence the development pipeline, and help bring new therapies to patients with significant unmet needs.

About our client

Our client is a biotechnology organization developing biologic therapies for difficult immune-mediated diseases. Its work combines scientific innovation and data-enabled drug development to advance potential treatments from discovery into clinical development. This role will help establish the operational foundation for the company’s next stage of growth.

The opportunity (Role summary)

As VP, Clinical Operations, you will define and execute the global operational strategy for early-stage clinical programs, including first-in-human, Phase 1, Phase 1b, and Phase 2a studies. You will lead cross-functional planning across clinical development, translational science, regulatory, CMC, safety, pharmacology, project management, finance, and business development.

This is an on-site leadership role reporting to the Chief Medical Officer. You will partner with contract research organizations, vendors, external collaborators, and senior governance groups to deliver high-quality studies across multiple geographies and regulatory environments.

Key responsibilities

• Lead global clinical operations strategy for early-stage programs.
• Build and develop a high-performing clinical operations function with clear accountability.
• Drive transition planning from candidate selection through regulatory clearance and first-in-human initiation.
• Partner with cross-functional teams to establish operationally feasible study designs and development plans.
• Oversee site activation, patient recruitment, investigator engagement, vendor governance, safety monitoring, and data review.
• Manage integrated operational plans, milestones, dependencies, resources, and budgets.
• Identify and mitigate scientific, regulatory, technical, and operational risks.
• Ensure adherence to GLP, GMP, ICH-GCP, regulatory, and ethical standards.
• Represent clinical operations in senior governance forums and external partnerships.
• Adapt operational plans in response to emerging clinical, translational, and safety data.

What you’ll bring

• PhD, MD, PharmD, or another advanced scientific or medical degree in immunology, inflammation, or a related field.
• 7–10+ years of biotechnology or pharmaceutical clinical operations experience.
• Significant leadership experience with global early-phase trials from first-in-human through Phase 2a proof of concept.
• Deep understanding of nonclinical, translational, regulatory, CMC, DMPK, and clinical pharmacology development.
• Experience managing complex trials, CROs, vendors, global regulatory filings, and safety oversight.
• Strong strategic thinking, stage-gate governance, and cross-functional influencing skills.
• Background in immunological diseases and biologic modalities is desirable.
• Experience supporting regulatory filings across major global health authorities is desirable.
• Experience with external partnerships, licensing, due diligence, or alliance management is desirable.

Call to action

Apply now to help shape the clinical development of innovative therapies for immune-mediated diseases.

Sometimes we use AI to draft job adverts using information from our CRM as part of our effort to work more efficiently so we can focus on what matters most: getting to know you. If you apply, a real person from our team will review your details and reach out. We’re committed to transparency, fairness, and human connection.