Senior Medical Director

• Act as medical monitor for assigned oncology studies




• Provide protocol-related medical review, eligibility and dose-modification guidance, and medical input to data review meetings




• Provide medical oversight and act as the escalation point for oncology studies across the assigned portfolio




• Advise on study design and measurements in clinical trials




• Review safety sections of study protocols and Investigator’s Brochures




• Review safety listings, adverse events, laboratory listings, vital signs and ECG data




• Review clinical trial reports from a safety perspective




• Assess adverse events and serious adverse events




• Conduct senior medical review of individual safety cases, cumulative case listings, PSURs, PBRERs, DSURs and Risk Management Plans




• Provide medical input to regulatory documents




• Conduct literature reviews and signal detection activities




• Contribute to departmental SOPs and tools




• Educate and supervise new Medical Advisors and Medical Directors




• Serve as a senior scientific voice in targeted oncology and hematology indications




• Represent the company at scientific and industry meetings, presentations, panels and advisory boards




• Contribute to publications, congress abstracts, white papers and articles




• Provide medical review of oncology communication materials




• Build and maintain networks of KOLs and investigators




• Monitor competitive landscapes, emerging standards of care and sponsor development pipeline trends




• Partner with Business Development on bid strategy, proposals, bid defense meetings and sponsor discussions




• Provide medical and scientific rationale for study design, feasibility and delivery strategy




• Develop sponsor relationships and contribute to oncology therapeutic-area strategy and service offerings

Requirements

• Medical degree (MD)




• Specialist medical training




• At least 10 years of post-qualification medical experience




• At least 7 years of oncology/haematology clinical development experience




• Substantial experience in a Medical Director role or equivalent in a CRO, biotechnology, or pharmaceutical organization




• Hands-on experience as medical monitor in oncology clinical trials, including review of emerging safety data and medically based decision-making during study conduct




• Experience as a member of safety data review boards in clinical trials, or equivalent experience




• Understanding of Good Clinical Practice regulations, International Council for Harmonisation (ICH) guidelines, Pharmacovigilance legislation and internal Standard Operating Procedures




• Excellent written and verbal communication skills




• Ability to work in a fast-paced environment with changing priorities




• Willingness to travel internationally for sponsor meetings and scientific events




• Experience of sponsor-facing scientific work in a CRO, pharmaceutical or biotechnology environment (desirable)




• Ability to translate scientific depth into a clear and credible message in sponsor-facing settings (desirable)




• Established external scientific profile in oncology, such as publications, congress presentations, advisory board participation or an active Key Opinion Leader network (desirable)

Core Competencies

Demonstrates extensive expertise in oncology clinical development, including medical monitoring, safety data review, and regulatory document input. Possesses strong communication skills and the ability to build relationships with key opinion leaders and stakeholders in the oncology field.

Highest-signal resume keywords

• Medical Degree (MD)




• Oncology Clinical Development Experience




• Medical Monitoring in Oncology Trials




• Good Clinical Practice (GCP) Regulations




• Safety Data Review Board Experience

ATS Optimization Keywords

Hard Skills

• Protocol-Related Medical Review




• Adverse Event Assessment




• Cumulative Case Listings Review




• Signal Detection Activities




• Literature Reviews




• Study Design Advisory




• Medical Input to Regulatory Documents




• Safety Data Review




• Risk Management Plans




• Oncology Communication Materials Review

Soft Skills

• Excellent Written Communication




• Excellent Verbal Communication




• Ability to Work in Fast-Paced Environment




• Supervision and Education of Medical Advisors




• Networking with KOLs

Certifications & Qualifications

• Specialist Medical Training

Industry Keywords

• Oncology




• Hematology




• Pharmacovigilance Legislation




• International Council for Harmonisation (ICH) Guidelines




• Clinical Trials




• CRO




• Biotechnology




• Pharmaceutical Organization




• Standard Operating Procedures (SOPs)




• Scientific Publications