OVERVIEW
Topography Health is seeking a Physician Investigator (MD) to lead and support research studies in the greater Denver area. This role offers a unique opportunity to collaborate with community-based practices, integrating clinical research into local physician settings. The ideal candidate will have a minimum five years of experience in clinical trials, with specific experience as Principal Investigator of vaccine or infectious disease studies. You should have prior experience in integrating clinical research into community physician practices, with a proven ability to lead and mentor clinical teams and a demonstrated commitment to advancing patient care through innovative research.
In this position, you will oversee the design, execution, and management of various clinical trials, ensuring that all studies comply with regulatory requirements and ethical standards. You will provide clinical expertise throughout the study lifecycle, skillfully identifying challenges and implementing effective solutions. Building trusting relationships with patients and fostering positive, collaborative partnerships with local physicians are crucial aspects of the role. Internally at Topography, you will work effectively with cross-functional teams and contribute to strategic planning, enhance clinical trial processes and patient experiences, helping Topography Health continue to provide valuable care options to patients and advance the field of clinical research.
KEY RESPONSIBILITIES
Oversee the design, execution, and management of vaccine clinical trials.
Ensure high-quality patient care and clear communication regarding study procedures.
Address patient concerns and contribute to a positive study experience.
Ensure studies comply with all regulatory requirements and ethical standards.
Provide clinical expertise and guidance throughout the study lifecycle.
Partner with local physicians to integrate clinical research into community practices.
Foster strong relationships to support patient recruitment and retention.
Offer mentorship and support to physicians new to clinical research.
Build trusting relationships with patients participating in clinical trials.
Work effectively with cross-functional teams, including clinical operations, regulatory affairs, and data management.
Participate in team meetings and contribute to strategic planning.
Support team members by providing clinical insights and problem-solving assistance.
Maintain up-to-date knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice.
Prepare, review, and approve study protocols, informed consent forms, and other essential documents.
Ensure accurate and timely reporting of adverse events and study outcomes.
Interpret clinical trial data and contribute to the preparation of study reports and publications.
Present findings to internal teams and external stakeholders as needed.
Stay informed about advancements in vaccine research and related fields.
Identify opportunities to enhance clinical trial processes and patient experiences.
Implement best practices to improve study efficiency and effectiveness.
Contribute to the development of innovative research methodologies.
Minimum Qualifications
Must possess an active and unrestricted medical license in Colorado.
5+ years of experience conducting vaccine clinical trials and/or infectious disease
5+ years of experience in clinical research methodologies, regulatory requirements, and ethical considerations.
5+ years of experience with FDA regulations, ICH guidelines, and GCP standards
Preferred Qualifications
Experience in neurology (e.g., Alzheimer's Disease) and/or psychiatry (e.g., Major Depressive Disorder) clinical studies
Prior experience integrating clinical research into community physician practices