UK remote
Senior Medical Director
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Senior Medical Director - home based in Spain, Germany, Sweden, UK, Poland or Portugal About this role As part of our CDS Hematology & Oncology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Senior Medical Director is the most senior medical role in the oncology therapeutic area. The role combines hands-on medical monitoring and portfolio-level medical oversight with responsibility for the scientific credibility and visibility of the company with current and future sponsors across the targeted indications in oncology and hematology defined for the therapeutic area (referred to below as the targeted indications).
The Senior Medical Director retains full medical authority: providing an authoritative medical opinion, answering medical based questions concerning medical, legal and regulatory matters, and acting in accordance with company policies, Standard Operating Procedures (SOPs) and regulatory requirements. The role acts as medical monitor for assigned oncology studies and, in parallel, provides medical oversight and escalation across the wider oncology portfolio.
The role also partners with Business Development to support the growth of the oncology business, contributing medical and scientific expertise to bid strategy, proposals, bid defense meetings and sponsor relationships. Key Responsibilities: Medical leadership and medical monitoring: Acts as medical monitor for assigned oncology studies, including protocol-related medical review, eligibility and dose-modification queries, ongoing review of emerging safety data, and medical input to data review meetings.
Provides medical oversight of, and acts as the escalation point for, oncology studies in delivery across the assigned portfolio. Provides advanced medical advice on study design and measurements in clinical trials. Reviews the safety sections of study protocols and of the Investigator’s Brochure. Reviews safety listings, including adverse events, laboratory listings, vital signs and electrocardiogram (ECG) data. Reviews clinical trial reports from a safety perspective.