Director/Senior Director, Clinical Operations

Director, Clinical Operations

Director/Senior Director

Location: Seattle, WA (ONSITE) / Remote Options Considerations

Company: Stealth Biotech

About the Company

We’re an early-stage, venture-backed biotech operating in stealth mode. We’re building a nimble team that thrives in ambiguity, moves quickly from idea to experiment, and collaborates closely across science and operations to inform decision-making. We believe in high activation energy and a roll-up-your-sleeves mindset.

The Opportunity

This is a foundational hire for our clinical operations engine. In this role, you will be the day-to-day conductor of our early-stage trials, taking protocol concepts and driving them through execution to the final study report. This role requires someone who can seamlessly transition between high-level vendor oversight and detailed protocol scrutiny. You will set the standard for operational rigor and GCP compliance as we scale our portfolio.

Key Responsibilities

Operational Execution

• Steer trials from concept to completion, owning the day-to-day operations that keep the portfolio advancing.
• Partner with Medical Director and other key functions to design, plan, and execute trials.
• Stay ahead of study quality metrics, spotting risks early and driving the action that keep goals and timelines on target.
• Maintain the Trial Master File (TMF), ensuring inspection-readiness at all times.
• Drive disciplined execution that adheres to every study protocol, SOP, GCP guideline, and regulatory requirement.

Vendor & Site Management

• Select, onboard, and manage CROs and third-party vendors, serving as the single point of accountability for what they deliver.
• Oversee investigator site selection and monitoring, including investigating queries and discrepancies.
• Negotiate and own vendor and site budgets, invoices, and payments.
• Train CRAs, investigational site staff, and third-party vendors on protocols, practices, and specific study documentation.
• Manage Clinical Trial Material/Investigational Product (IP) accountability, release, and reconciliation workflows.

Data & Documentation

• Dig into clinical data listings and summary tables to raise, track, and resolve queries.
• Author, prepare, and/or contribute to critical clinical documentation, including clinical protocols, amendments, Informed Consent Forms (ICFs), Case Report Forms (CRFs), and study manuals.
• Oversee the planning and conduct of internal team meetings and investigator meetings.

What You’ll Bring

Qualifications

• Bachelor’s degree or equivalent in a science or health-related field; advanced degree (MS, PhD, PharmD, or MD) strongly preferred.
• 10 years of clinical operations experience in a pharmaceutical or biotech setting, including 3 years in a functional or team leadership role.
• Demonstrated success building or scaling a clinical operations function at an early-stage or mid-size company.
• Deep, working knowledge of ICH/GCP, FDA regulations, and international clinical trial requirements.
• Proven track record managing CROs and external vendors across multiple concurrent studies, with direct accountability for timelines and budgets.
• Excellent project management and interpersonal skills, with exceptional attention to detail.
• Specific experience with first-in-human healthy volunteer, pediatric, and/or viral disease trials (strongly preferred).
• Work experience in early-stage or start-up environment.

Traits for Success

• Highly motivated self-starter with high curiosity and a flexible, detail-oriented approach.
• Team-oriented communicator and collaborator capable of engaging effectively with scientists, clinicians, and investigators.
• Thrives in ambiguity and is quality-driven, eager to establish efficient workflows.

Title & Level

Level open: we anticipate hiring between Director, Clinical Operations and Senior Director, Clinical Operations, depending on experience.