Director, Clinical Operations

About the Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.   

About the Role

This role will support the planning and execution of clinical trials, including biopharma partnerships and Foresight-sponsored studies. This role will work collaboratively with Medical Affairs, Quality Assurance, Regulatory Affairs, and the Production clinical laboratory as well as with external stakeholders such as the biopharma partners, clinical research organizations, clinical investigators, and ethics committees. This position is a hybrid preferred, but fully remote will be considered. Periodic travel may be required.

Responsibilities 

• Manage contract and/or full-time clinical research associate(s).

• Plan and execute clinical trial readiness activities for biopharma partnership clinical trials, including phase I-III and biomarker qualification studies.

• Oversee and execute clinical operations activities related to laboratory testing for biopharma partnerships, including:

  •  In-house monitoring of source and laboratory data

  • Manage and resolve biospecimen or data issues with Sponsor, CRO, or other study partners

  • Monitor and report adverse device effects

• Oversee and execute clinical operations activities for prospective, sponsored trials, including:

  • Site and trial-level budget development

  • Site feasibility evaluation and site activation

  • Oversight of trial conduct, including monitoring

  • Site and trial close-out

• Oversee and execute IRB submissions and applicable regulatory submissions (e.g. adverse device event reporting)

• Oversee TMF set-up and maintenance for all new and on-going studies

• Maintain and update clinical operations documents that govern trial conduct

Skills and Qualifications

• Certification in Good Clinical Practice and Human Subjects Research

• At least 5 years of experience in Clinical Operations

• Experience building and managing a team

• Experience in molecular diagnostics and oncology preferred

• Excellent written and verbal communication skills

• Detail-oriented and able to manage multiple projects at the same time

• Proficiency in Microsoft products

• Strong strategic thinking and problem-solving skills

This role is offering a salary between $180,000-205,000 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside …