Director​/Senior Director, Clinical Operations

Location:

Seattle, WA (ONSITE) / Remote Options Considerations

Company:
Stealth Biotech

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.

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.

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.
• 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.

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.

• 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.

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