Make a difference in the world of medical equipment!
Join MedTrace as a Medical Advisor 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'll collaborate with internal partners, external stakeholders, and physicians to shape the clinical development strategy.
To be successful in this role, it is necessary to be at the sites as needed and to work closely with the other customer facing teams (compliantly) to support the research needs of any MedTrace technology users. You will support the Phase 3 trial through direct involvement in the trial site activation process and ongoing support for 150 water manufacturing, providing MedTrace representation at clinical operations meetings, investigator meetings, congresses and with vendor oversight and clinical documentation and protocol support. Further, you will discuss and evaluate other research proposals (both external and internal, as needed) and help in the development of clinical protocols. You will also be asked to support efforts to generate clinical SOPs as MedTrace expands its clinical operations, to assist with medical writing as needed, and to support regulatory submissions in the US and Canada.
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:
- Maintain relationships with researchers and potential researchers in the US and Canada.
- Support site activation process and maintenance of trial sites.
- Support the Phase 3 clinical trial recruitment, operations, and vendor oversight.
- Collaborate with clinical affairs team on protocol generation and external protocol reviews.
- Support development of clinical evidence generation plan for 15O-water and aQuant and drive the execution of the clinical affairs strategy.
- Provide clinical input and support for internal teams for various ongoing projects.
- Contribute to clinical gap analysis and provide unique solutions to generating clinical data across different disease states.
- Support the creation of a 15O-water literature database.
- Liaise with societies and coalitions on initiatives and dialogue about current state of the science/industry and outlook for the future in terms of directions of interest and regulatory changes.
- Develop materials and communicate scientific and medical information to various audiences, for educational purposes.
- Contribute to understanding the US market, especially in terms of market access.
- Comply with MedTrace internal procedures and Quality Assurance processes as well as documentation of new processes and changes.
As a person you are:
- Self-motivated team player with strong relationship-building skills.
- Thrive on learning new things and taking on projects outside your expertise.
- Possess excellent problem-solving skills and a passion for science and knowledge and an openminded and 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.
- Advanced degree in medical sciences.
- Nuclear Pharmacist certification preferred.
- Minimum 10 years of clinical development or medical affairs experience, imaging/radiopharmaceutical/diagnostic experience preferred.
- Experience/training in ICH/GCP.
- Experience in clinical trials within cardiology, oncology, or nuclear medicine
- Willingness to travel up to 40%, including international travel.
- Understanding of compliance.
- Adequate skills in medical writing.
- Fluent in English.
Bonus if you have:
- Industry work experience in medical affairs or clinical development teams.
- Nuclear Pharmacist with cGMP PET radiopharmaceutical manufacturing experience.
- Experience supporting US regulatory submissions.
- Previous work experience as an MSL.
Interviews will be held on an ongoing basis as applications are received. For inquiries, contact Emily Vandenbroucke at firstname.lastname@example.org