MedTrace
Director, Clinical Research
MedTrace, Minneapolis, Minnesota, United States, 55400
We are hiring! Join a diverse and energetic team working to eliminate diagnostic uncertainty.
The team that’s building MedTraceAs a young company with an exciting new approach to medical imaging, MedTrace is a dynamic place where individuals are encouraged to take responsibility and the passion and drive is high. Everyone on our team is involved in creating their own job and doing their part to help achieve our vision of eliminating diagnostic uncertainty.
We hire genuine diversityWhen we hire for our team, we’re interested in diversity not just of gender or ethnic origin, but also diversity of age and diversity of experience. We hire people at many different stages of their careers and from many different professional backgrounds. We believe this varied way of looking at the world creates a lively professional environment and a product that can serve many different types of patients. Also, everyone is given equal opportunities at MedTrace.
Director, Clinical ResearchMinneapolis, MN
Make a difference in the world of medical equipment!
Join MedTrace as a Director 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, candidates throughout the US will be considered. You'll collaborate with internal partners, external stakeholders, and physicians to shape the clinical development strategy.
To be successful in this role, you must be able to organize complex projects, provide attention to detail, and communicate effectively. Manage the day-to-day research operations and objectives in support of the assigned projects; contribute information and ideas related to areas of responsibility as part of a variety of teams across all projects; and ensure effective and efficient workflow and adherence to quality standards for staff/program and self. The role of Director of Clinical Research will be responsible for responsive interactions with state and federal partners; compliance with regulatory requirements; budgetary oversight including monitoring and tracking projects; grant and contract development and negotiations; and project reporting.
Your personal values include drive, a passion for your work, responsibility, and a commitment to diversity and equality. You enjoy a working environment that is dynamic and versatile and want a job you can shape according to your strengths and qualifications.
Key responsibilities and requirements:
Manage the day-to-day planning, design, and execution of clinical trials for the company. This involves drafting study protocols, reports, managing CROs, overseeing field monitoring activities, and ensuring 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). This involves site selection, contract negotiations, and ongoing communication.
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.
As a person you are:
Self-motivated and independent, but also a team player.
Good at relationship building.
Thrive on learning new things and taking on projects outside your expertise.
Possess excellent problem-solving skills and an open-minded approach to diverse cultures.
You thrive in an organization that includes diverse cultures and people at all organizational levels, and you are excited about the opportunity to be part of a scale-up company and help shape its future.
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.
Bonus if you have:
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.
Interviews will be held on an ongoing basis as applications are received. For inquiries, contact Nicholas Borys at nicholas@medtrace.dk
We look forward to hearing from you!
#J-18808-Ljbffr
The team that’s building MedTraceAs a young company with an exciting new approach to medical imaging, MedTrace is a dynamic place where individuals are encouraged to take responsibility and the passion and drive is high. Everyone on our team is involved in creating their own job and doing their part to help achieve our vision of eliminating diagnostic uncertainty.
We hire genuine diversityWhen we hire for our team, we’re interested in diversity not just of gender or ethnic origin, but also diversity of age and diversity of experience. We hire people at many different stages of their careers and from many different professional backgrounds. We believe this varied way of looking at the world creates a lively professional environment and a product that can serve many different types of patients. Also, everyone is given equal opportunities at MedTrace.
Director, Clinical ResearchMinneapolis, MN
Make a difference in the world of medical equipment!
Join MedTrace as a Director 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, candidates throughout the US will be considered. You'll collaborate with internal partners, external stakeholders, and physicians to shape the clinical development strategy.
To be successful in this role, you must be able to organize complex projects, provide attention to detail, and communicate effectively. Manage the day-to-day research operations and objectives in support of the assigned projects; contribute information and ideas related to areas of responsibility as part of a variety of teams across all projects; and ensure effective and efficient workflow and adherence to quality standards for staff/program and self. The role of Director of Clinical Research will be responsible for responsive interactions with state and federal partners; compliance with regulatory requirements; budgetary oversight including monitoring and tracking projects; grant and contract development and negotiations; and project reporting.
Your personal values include drive, a passion for your work, responsibility, and a commitment to diversity and equality. You enjoy a working environment that is dynamic and versatile and want a job you can shape according to your strengths and qualifications.
Key responsibilities and requirements:
Manage the day-to-day planning, design, and execution of clinical trials for the company. This involves drafting study protocols, reports, managing CROs, overseeing field monitoring activities, and ensuring 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). This involves site selection, contract negotiations, and ongoing communication.
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.
As a person you are:
Self-motivated and independent, but also a team player.
Good at relationship building.
Thrive on learning new things and taking on projects outside your expertise.
Possess excellent problem-solving skills and an open-minded approach to diverse cultures.
You thrive in an organization that includes diverse cultures and people at all organizational levels, and you are excited about the opportunity to be part of a scale-up company and help shape its future.
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.
Bonus if you have:
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.
Interviews will be held on an ongoing basis as applications are received. For inquiries, contact Nicholas Borys at nicholas@medtrace.dk
We look forward to hearing from you!
#J-18808-Ljbffr