Director, Clinical Operations

Director, Clinical Operations – Medicines360

Position Title : Director, Clinical Operations.

Reports to : CEO.

FLSA Status : Full-time, Exempt.

Base pay range : $210,000.00 / yr – $225,000.00 / yr.

Location : Redwood City, CA (salary $180,000.00–$220,000.00).

Position Summary

The Director of Clinical Operations will lead the translation of discovery findings into clinically and commercially viable products, focusing on women’s health devices. This role is pivotal in advancing projects from early research through clinical development, regulatory submission, and commercialization. The Director will oversee all aspects of clinical trials across Medicines360's pipeline, from feasibility studies to pivotal studies, ensuring high-quality, timely, and cost-effective execution.

Essential Duties and Responsibilities

• Lead the clinical development of women’s health devices and diagnostics from early feasibility to regulatory submission and commercialization.
• Drive cross‑functional R&D initiatives, aligning clinical objectives, timelines, and budgets with overall program strategy.
• Oversee all aspects of study execution, including protocol development, site and vendor selection, contracting, enrollment strategy, training, monitoring, and reporting.
• Collaborate with biostatistics, data management, legal, and regulatory teams to ensure robust study design, effective data analysis plans, and compliant documentation.
• Manage external partners, including CROs, laboratories, and investigators, ensuring performance, issue resolution, and audit readiness.
• Develop and oversee study budgets in collaboration with Finance, ensuring transparency and alignment with corporate goals.
• Prepare for and support regulatory inspections and global submissions (e.g., FDA, MHRA).
• Build and maintain partnerships with external stakeholders and key opinion leaders; identify and integrate novel technologies to advance women’s health innovation.
• Contribute to publications, presentations, and other scientific communications.
• Model Medicines360’s mission and values by championing access, collaboration, and scientific integrity across all clinical programs.
• Serve as the operational lead for strategic, cross‑functional R&D initiatives, ensuring early alignment between clinical goals and overall timelines and budgets.
• Produce and maintain clinical study‑related documentation, including Protocols, Investigator Brochures, Informed Consents, and Clinical Study Records.
• Oversee vendor selection, contracting, and site qualification processes.
• Collaborate with cross‑functional teams to develop Statistical Analysis Plans and Data Management Plans.
• Secure IRB / EC approvals and negotiate Clinical Trial Agreements.
• Ensure appropriate training of study team members to maintain compliance and operational consistency.
• Identify risks within clinical studies and implement mitigation strategies.

Essential Skills & Qualifications

Travel and Physical Demands

Ability and willingness to travel up to 30% including international travel as required.

EEO Statement

Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.

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