Sr. Director, Clinical Operations

The role

This Senior Director will lead the hands-on execution of early clinical development activities for the company's first-in-human program. The role involves clinical operational planning, study execution, and vendor management.

What you will do

• Lead clinical operations planning and execution for early development programs.
• Develop study plans, timelines, budgets, forecasts, and risk-mitigation strategies.
• Lead CRO and vendor selection and oversight.
• Partner with Clinical Development and Medical leadership to evaluate protocols and study designs.
• Represent Clinical Operations on cross-functional study and program teams.
• Develop and execute the Phase 1 site strategy.
• Lead global clinical operations activities across the U.S., Europe, Australia, and other ex-U.S. regions.
• Contribute to operational planning for potential studies in China.
• Establish an operating cadence with CROs, sites, vendors, and consultants.
• Oversee the development and maintenance of study-level operational documentation.

Required qualifications

• BS/MS/PhD degree in a scientific, healthcare, or related discipline
• 10+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry
• Direct experience leading first-in-human or Phase 1 studies
• Strong working knowledge of CRO and vendor selection and oversight, site strategy, global study start-up, and operational planning
• Demonstrated experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts
• Experience reviewing clinical protocols and translating study designs into executable operational plans
• Experience supporting clinical pharmacology/DMPK, including dose-escalation, SAD/MAD, biomarker, or other early-phase study designs
• Experience conducting studies involving healthy volunteers/specific patient population
• Broad understanding of FDA, EU, and other ex-U.S. clinical trial requirements
• Strong knowledge of ICH-GCP, sponsor oversight responsibilities, TMF requirements, clinical quality standards, and inspection readiness
• Ability to operate independently and influence without direct authority in a fast-paced environment
• Ability and willingness to travel domestically and internationally, as needed

Nice to have

• Experience in both biotechnology and pharmaceutical company environments
• Direct experience initiating and executing early-phase studies in Australia
• Experience with China regulatory and clinical operations pathways
• Experience in antibody therapeutics, biologics, or other advanced therapeutic development programs
• Experience operationalizing biomarker, immunogenicity, pharmacokinetic, pharmacodynamic, or other specialized sample-collection and bioanalytical strategies
• Experience establishing clinical operations infrastructure, processes, systems, and external partnerships

Benefits

• healthcare coverage
• annual incentive program
• retirement benefits
• broad range of other benefits

About the company

Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Their platform brings together live-cell experimentation and AI/ML to understand how biological mechanisms drive functional outcomes in living systems.