Job purposeThe 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.
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 - 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.
- 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 time-lines
- 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 escalate.
- Accountability for outcomes, openness to feedback and a continuous-improvement mindset
The salary range for this position is 150,000 to 175,000.
