Director, Clinical Research

Medtrace - Minneapolis, MN

Full-time - Senior

Minneapolis, MN

About the position

Join MedTrace as a Director of Clinical Research and play a crucial role in advancing our mission to make 15O-water practically available. As part of our international Clinical Development team based in the US office in Minneapolis, you will collaborate with internal partners, external stakeholders, and physicians to shape the clinical development strategy. This position is pivotal in managing the day-to-day research operations and objectives in support of assigned projects, contributing valuable information and ideas as part of various teams across all projects. You will ensure effective and efficient workflow while adhering to quality standards for both staff and programs, as well as for yourself. In this role, you will be responsible for maintaining responsive interactions with state and federal partners, ensuring compliance with regulatory requirements, and overseeing budgetary aspects including monitoring and tracking projects. You will also be involved in grant and contract development and negotiations, as well as project reporting. Your personal values should align with drive, passion for your work, responsibility, and a commitment to diversity and equality. You will thrive in a dynamic and versatile working environment, shaping your job according to your strengths and qualifications. Key responsibilities include managing the planning, design, and execution of clinical trials, which involves drafting study protocols and reports, managing CROs, overseeing field monitoring activities, and ensuring data quality. You will ensure adherence to good clinical practice (GCP) guidelines, FDA regulations, and standard operating procedures throughout all clinical research activities. Additionally, you will manage relationships with clinical trial sites, principal investigators, and CROs, which includes site selection, contract negotiations, and ongoing communication. You will oversee a team of clinical research professionals, collaborate with other departments to support the overall development strategy, analyze and interpret clinical trial data, and prepare clinical study reports. Staying updated on advances in cardiovascular imaging and relevant regulatory requirements is essential, as is presenting progress reports and tactical/strategic plans to upper management and oversight committees. You will also implement risk management strategies to identify and mitigate potential issues in clinical trials, contributing to the company's overall research and development strategy.

Responsibilities

• Manage the day-to-day planning, design, and execution of clinical trials for the company.
• Draft study protocols and reports, manage CROs, oversee field monitoring activities, and ensure data quality.
• Ensure adherence to good clinical practice (GCP) guidelines, FDA regulations, and standard operating procedures throughout all clinical research activities.
• Manage relationships with clinical trial sites, principal investigators, and contract research organizations (CROs).
• Oversee a team of clinical research professionals, including clinical research associates, data managers, and medical writers.
• Collaborate with other departments such as regulatory affairs, operations, and European clinical teams to support the overall development strategy for the company.
• Analyze and interpret clinical trial data, prepare clinical study reports, and contribute to regulatory submissions.
• Work with project management to develop and manage budgets for clinical research programs.
• Stay updated on advances in cardiovascular imaging and relevant regulatory requirements.
• Present progress reports and tactical/strategic plans to upper management and oversight committees.
• Ensure the quality and integrity of clinical data collected during trials.
• Implement risk management strategies to identify and mitigate potential issues in clinical trials.
• Contribute to the company's overall research and development strategy.

Requirements

• Extensive experience (usually 10+ years) in clinical research, preferably in cardiovascular imaging or diagnostics.
• Recent phase 3 study and NDA submission experience is strongly preferred.
• Minimum five plus years experience managing clinical studies and CROs.
• Strong knowledge of FDA regulations and ICH guidelines related to clinical trials.
• Excellent leadership, communication, and project management skills.
• Experience in managing complex, multi-site clinical trials.
• Bachelor's degree minimum and advanced degree a plus.
• Fluent in English.

Nice-to-haves

• Industry work experience with radiopharmaceuticals or radioactive materials.
• An advanced degree (MD, PhD, or PharmD) with a focus on cardiovascular medicine or related field.
• Recent experience in NDA submission.