Medical Director/Associate Medical Director - Clinical Development

JOB TITLE - AD/Medical Director - Clinical Development

JOB TYPE - Permanent

LOCATION - Oxford (Hybrid)

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 programme strategy under the direction of the Medical Director.

Main Responsibilities, Activities, Duties and Tasks

• Provide medical direction to company 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 programme 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.

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

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