Manager, Medical Affairs

About Blue Earth Diagnostics:

Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.

About the role

The Medical Affairs team at Blue Earth Diagnostics is seeking a an experienced and detail-oriented Manager, Medical Affairs to oversee the planning, execution, and delivery of the Investigator Initiated Trials program. This individual will play a critical role in ensuring trials are conducted in compliance with proper regulatory requirements and company SOPs. The ideal candidate will be proactive with managing the day-to-day responsibilities (track trial progress and metrics and prepare updates for internal meetings) of managing a robust Investigator Initiated Trials program which includes, but is not limited to, working on contracts and budgeting needs on a regular basis. Experience speaking with and collaborating with external institutions is highly recommended and general medical knowledge is required. The candidate will also spend a lesser portion of his or her time managing the patient advocacy program and experience with patient/support groups recommended.

This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA.

Main Responsibilities, Activities, Duties and Tasks

• Manage the day-to-day operations of the Investigator Initiated Trial program (90%) including but not limited to the following:
  • Ensure all trials are conducted according to protocol, GCP, and applicable regulatory requirements.
  • Manage Investigator Initiated Trial budgets and interact with internal finance department
  • Coordinate with contracts and legal departments for study agreements and sponsor negotiations.
  • Act as a primary contact between BED and study sites for management of Investigator Initiated Trials
  • Collaborate with investigators, clinical operations, and other departments to ensure trial success.
  • Manage and oversee trial documentation and troubleshoot and resolve operational study issues
  • Monitor trial progress, track milestones, and ensure timelines and budgets are met. Interact and coordinate with internal BED medical team to ensure success of trials.
  • Organize monthly Scientific Review Committee meetings to review new proposals and update team on status of trials as needed
• Manage the day-to-day operations of the Patient Advocacy program (10%) including but not limited to the following:
  • Building and maintaining strategic relationships with patient advocacy groups and patient communities.
  • Support access, education, and engagement initiatives that reflect the needs and priorities of patient advocacy groups
  • Develop and maintain strong relationships with patient advocacy organizations, community groups, and key opinion leaders.
  • Represent the company at patient-focused events, conferences, and meetings.
  • Monitor and report on trends in the patient advocacy landscape, including policy developments, unmet needs, and feedback from the community.
• Other duties as determined by business needs

Education/Qualifications

• Master’s Degree required in life science or related field. Doctorate degree preferred. 5-10 years experience in clinical trial management within pharmaceutical, biotech, or CRO environments. Excellent organizational, problem-solving, and communication skills and ability to work independently.

Professional Experience, Knowledge, & Technical Skills

• Knowledge with PPT, Excel and SAP required. Ability to work with and across different functions. Proven experience in a trial management role and ensuring timely and compliant trial conduct.

How to Apply:

Please submit your CV and a cover letter outlining:

• Why this role appeals to you.
• How your background and skills are suited to this role.

Why Blue Earth Diagnostics?

We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a dynamic company experiencing rapid growth, BED prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way.

If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you.

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, generous paid holidays, and promote work/life harmony.

Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.

Annual Salary: $130,000.00-$150,000.00

Why Blue Earth Diagnostics?

We are seeking motivated individuals with drive and determination to succeed in an innovative and respectful team environment. Our employees are empowered to achieve great things and thrive in our exceptionally co-operative culture. As a young and dynamic company experiencing rapid growth, Blue Earth Diagnostics prides itself on providing a clear focus and incentives to achieve our business-critical objectives. We aim to have fun and celebrate each milestone along the way.

If you are seeking a job where you have a clear impact on business success, are working with talented and collaborative colleagues daily, and are doing something great for human healthcare, then this job is for you.

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays.

Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.