Associate Medical Director, Clinical Development

About the role

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. The Associate Medical Director provides study-level medical and scientific leadership for assigned Phase I‑IV clinical trials of diagnostic radiopharmaceuticals, ensuring medical integrity, participant safety, and clinically robust execution from protocol development through close‑out.

Responsibilities

• 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 escalate 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.
• Perform other duties as determined by business needs.

Requirements

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.

Qualifications

Clinical (patient care or research) experience beyond that obtained during the medical degree.

Skills

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.

Benefits

Comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays.

Pay

Highly competitive salary for high‑caliber candidates.

Schedule

Hybrid work schedule with the expectation of working onsite 3 days a week at the office located at 197 First Avenue, Needham, MA. Travel required domestically and internationally up to 20% of the time, if needed, for conferences, investigator/KOL meetings and company events.