Director, Clinical Development Operations

Job Title: Director, Clinical Development Operations

Location: Remote in the United States

About Our 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

The Director, Clinical Development Operations will oversee the planning and execution of clinical trials, including biopharma partnerships, investigator-initiated studies, and Foresight-sponsored studies under IDE and ISO regulations and GCP guidance. 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. Periodic travel may be required.

What You Will Do

• Manage the clinical operations team of Clinical Study Managers, Clinical Research Associates, Research Project Coordinators, and Data Managers in the successful execution of clinical trials.

• Lead biopharma partnerships through feasibility and due diligence to study start-up and execution, meeting all contractual obligations, milestones and deliverables.

• Support clinical operations team members in the implementation of clinical study protocols and operational plans, which are consistent with strategic corporate objectives.

• Coordinate clinical study timelines with cross-functional teams to meet critical milestones; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.

• 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; and

  • 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.

What You Will Bring

• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training and experience.

• 10+ years clinical trial experience in the biopharmaceutical or diagnostic industry.

• 7+ years of experience leading project operational teams through the start-up, study conduct, data management, and report writing/review for clinical studies of molecular diagnostics/In Vitro Diagnostics.

• Experience working at or with a central lab, diagnostics laboratory or biopharmaceutical company managing Companion Diagnostic studies.

• Management experience.

• Good knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research with documentation of GCP training.

• Working knowledge of the FDA submission process including IDE, PMA, and 510(k).

• International study experience and GDPR implementation.

• Experience handling complex clinical data sets including genomic data.

• 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.

Physical and Mental Requirements, Working Conditions

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.

• Travel up to 25%.

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

• This position requires the ability to identify and resolve quality issues.

Compensation and Benefits

This role is hiring at an annual salary of $190,000 - $220,000 and is eligible for bonus and equity offerings.

The hiring salary range is applicable across the continental United States. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.