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 world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
ABOUT THE OPPORTUNITY
Visby is seeking a Director 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 Director 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 Director will lead a group that includes clinical research scientists, 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. A strong interest or experience in human factors research is a plus.
HOW YOU’LL MAKE AN IMPACT
- Leads the group in planning, execution, and interpretation of clinical trials/research.
- Oversees and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports as well as publications based on the clinical trials/research.
- Oversees development, implementation and maintenance of appropriate 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.
- Responsible for execution of clinical studies to support US and OUS regulatory submissions.
- Ensure that clinical affairs is effectively represented in new product development activities.
- Collaborators with R&D to support beta studies and obtaining clinical samples to support product development. Maintains a biorepository.
- Participates in the design of human factors and post market studies and provides support, as requested.
- Maintains an effective working relationship with external collaborators, including principal investigators, CROs and reference laboratories.
- Stays current with market and regulatory developments.
- Routinely interacts with and reports to executive-level management on progress of Clinical Affairs programs and studies.
- Oversees management of the budget and planning for Clinical Affairs.
ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE (Requirements & Education)
- Bachelor’s degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or equivalent with 10+ years of experience or a Master’s/Doctoral degree with 8+ years of experience
- 3+ years of experience mentoring, managing, and leading a team
- 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
MORE ABOUT THE TEAM
- The clinical affairs team is composed of clinical scientists, clinical research associates and clinical research assistants.
UNIQUE ASPECTS OF THIS JOB
- Travel: Minimal travel (up to 5%) to Moderate travel (10-20%)
- Schedule: Hybrid or remote. If remote, be in office at least one week a month.
- Physical aspects: Standard office work environment
- $190,000 - $240,000 (Minimum to maximum 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 candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.
More about our benefits
Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.
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.