Associate Medical Director, Clinical Development

Blue Earth Diagnostics Inc.; Needham (MA); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Healthcare plan

401k with matching

Work-life harmony

Generous paid holidays

Job summary

Blue Earth Diagnostics Inc. seeks an Associate Medical Director to lead medical and scientific activities for Phase I–IV diagnostic radiopharmaceutical trials.

You will oversee medical monitoring, data review, and investigator engagement to ensure safety and robust study interpretation. Collaborating with Clinical Operations, Regulatory, and other functions, you will contribute to regulatory submissions, publications and development decisions under the Medical Director.

Qualifications

• MD or equivalent medical degree with postgraduate clinical training or specialty certification.
• Experience in clinical development lifecycle, pharmacovigilance and safety review.
• Supervision of projects and timelines in a pharmaceutical/biotech setting.

Responsibilities

• Provide study-level medical and scientific leadership for Phase I–IV trials of diagnostic radiopharmaceuticals.
• Lead medical data review, safety assessment, and regulatory documentation.
• Collaborate with cross-functional teams to ensure compliant, timely study delivery.
• Support health-authority submissions and program strategy under the Medical Director.

Skills

Clinical trial experience

Medical monitoring

Data review & safety

Regulatory submissions

Education

MD or equivalent first medical degree

Postgraduate clinical training/certification in oncology/radiology/nuclear medicine/pharma medicine

Job description

About Blue Earth Diagnostics

Blue Earth Diagnostics, a subsidiary of Bracco Imaging, is a global company advancing precision molecular imaging to support timely decisions and better patient outcomes. Founded in 2014, we work closely with clinicians and collaborators, bringing deep expertise to the development and delivery of positron emission tomography (PET) radiopharmaceuticals. Our growing portfolio helps uncover disease sooner and guide treatment choices across multiple disease states, including oncology and cardiology. Backed by a dedicated team, we deliver clear answers when decisions matter most.

Job purpose

The Associate Medical Director provides study-level medical and scientific leadership for assigned Phase I-IV clinical trials of diagnostic radiopharmaceuticals. The role is accountable for the medical integrity, participant safety and clinically robust execution of each study from protocol development through close-out. The Associate Medical Director performs medical monitoring for insourced studies and provides sponsor oversight of outsourced medical monitoring, including the quality and consistency of medical decisions and appropriate escalation. Working within cross‑functional study teams, the role leads medical data and safety review, investigator engagement, study-level interpretation and reporting, and contributes to regulatory activities and program strategy under the direction of the Medical Director.

Main Responsibilities, Activities, Duties and Tasks

Provide medical direction to BED‑sponsored Phase I‑IV global clinical development activities for radiopharmaceuticals. Develop and review study documents, including protocols, Investigator Brochures, case report forms, medical monitoring and data review plans, clinical study reports and study‑level regulatory documentation. For insourced studies, act as the sponsor medical monitor. For outsourced studies, define and approve the medical monitoring approach and escalation criteria, oversee the vendor medical monitor and ensure timely, consistent and appropriately documented decisions. Provide or oversee participant‑level medical decisions relating to eligibility, protocol interpretation, investigator queries, protocol deviations, concomitant medication and safety findings. Conduct ongoing medical and safety review, identify emerging trends or potential signals, support pharmacovigilance with individual case and aggregate assessments, and promptly escalation issues that may affect program benefit‑risk or participant protection. Lead medical data review, clinical query strategy, data review meetings and assessment of medical readiness for database lock. Interpret study results and contribute to clinical study reports, regulatory submissions, publications, congress materials and internal development decisions. Build effective relationships with investigators, key opinion leaders and sites; support investigator and site identification, feasibility, recruitment, investigator meetings and relevant advisory activities. Collaborate with Clinical Operations, Imaging, Biometrics, Pharmacovigilance, Regulatory, Quality, CMC and other functions to identify and resolve study risks, maintain inspection readiness and deliver agreed timelines. Provide study‑specific medical input to health‑authority submissions, responses and meetings, and communicate study status, risks, recommendations and required escalations to the Medical Director. Maintain clear study‑level medical documentation, capture lessons learned and contribute to development and continuous improvement of relevant SOPs, policies, templates and ways of working. Other duties as determined by business needs.

Education

MD or equivalent first medical degree, with postgraduate clinical training and/or certification in oncology, radiology, nuclear medicine, pharmaceutical medicine or another relevant specialty. Current or recent registration with the UK General Medical Council, EU or US equivalent, or eligibility for such registration. A higher research degree or other formal training in clinical research or drug development is desirable.

Travel requirements

Able to travel domestically and internationally up to 20% of the time, if required. Attendance at conferences, investigator/KOL meetings, and company events may be required.

Professional Experience, Knowledge & Technical Skills

Clinical (patient care or research) experience beyond that obtained during medical degree. Working knowledge of the clinical development lifecycle, Good Clinical Practice, protocol design, safety surveillance and pharmacovigilance, medical data review, clinical study reporting and clinical content for IND/CTA and marketing‑application documentation. Business and market knowledge; pharmaceutical/biotech experience. Awareness and understanding of good clinical practice in an industry setting. Experience in supervision of projects and driving timelines. Skills in interpretation/evaluation of clinical data. Demonstrated record of scientific/medical presentations/publication. Capable of conducting doctoral level discussions with investigators / collaborators.

Soft Skills – Company Values & Behaviors

Excellent oral and written communication skills. Collaborative working style with the ability to influence and constructively challenge across a global matrix without relying on formal authority. Highly organized, proactive and detail‑oriented, with the ability to manage multiple priorities and make timely, well‑documented decisions. Pragmatic and adaptable in a small‑company environment, with good judgement regarding when to act independently and when to elevate. Accountability for outcomes, openness to feedback and a continuous‑improvement mindset.

Salary range

The salary range for this position is 150,000 to 175,000.

Benefits

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.

Equal Opportunity

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.

Our Purpose

Improve people’s lives by shaping the future of prevention and precision imaging. This is our purpose. Our work impacts millions of people all over the world. Not least the more than 4,000 Bracco colleagues who work to improve lives every single day. That is quite a responsibility and something we proudly embrace. We are the Bracco Group!