Job Description

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About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the worlds first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the worlds first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About The Role

Visby is seeking a Manager of Clinical Affairs to lead clinical and preclinical studies for our portable molecular infectious disease PCR device. Visby is dedicated to bringing high-quality diagnostic test results closer to the patient, including to the home. The Manager is responsible for collaborating with R&D and Regulatory Affairs to design clinical studies to support product development and regulatory submissions and for all aspects of study execution. The Manager will lead a group that includes clinical research associates and clinical research assistants. This position requires a strong background in all aspects of conducting clinical studies in a regulated environment and the ability to innovate and bring creative ideas to conducting diagnostic clinical studies in at home settings.

How You'll Make An Impact

• Leads clinical research associates and clinical research assistants in planning, execution of clinical trials/research.
• Contributes to the scientific methods for design and implementation of clinical protocols and final reports as well as publications based on the clinical trials/research.
• Responsible for development, implementation and maintenance of standard operating procedures and policies to ensure compliance with regulations, guidelines and standards related to clinical studies.
• Collaborates with Regulatory Affairs and R&D to design preclinical studies for product development and clinical studies to support regulatory approvals.
• Collaborators with R&D to support preclinical studies and obtaining clinical samples to support product development. Maintains a biorepository.
• Supports human factors and post market studies, as requested.
• Maintains an effective working relationship with external collaborators, including principal investigators, CROs and reference laboratories.
• Routinely interacts with and reports to executive-level management on progress of Clinical Affairs programs and studies.
• Works with executive management to oversee management of the budget and planning for Clinical Affairs.

On Your First Day We'd Like You to Have

• Bachelors degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or equivalent with 5+ years of experience or a Masters/Doctoral degree with 3+ years of experience
• Minimum 2 years experience with In Vitro Diagnostic or Medical Device Clinical Trials

It's Great If You Have

• Successfully led and executed clinical studies that supported FDA clearance/approval of In Vitro Diagnostic (IVD) products and CE Marking.
• Experience and/or training in molecular biology and a comprehensive understanding of PCR.
• Working knowledge of the IVDR requirements for clinical studies.
• Proven management and leadership skills
• Data analysis and/or laboratory skills

Salary Range

• $150,000 - $180,000 (salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location.
• Compensation also depends on a number of factors including a candidates qualifications, skills, competencies and experience and may fall outside of the range shown.

More About Our Benefits

Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option. We also offer flexible paid time off, 10 company holidays, and many other contemporary benefits and perks.

Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.

Additional Information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Management

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

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Job Tags

Full time, Remote work, Flexible hours,

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