Senior Medical Director – Oncology
TFS HealthScience · Nzalae/ Nzawa locations
Job description
About the role
As a Senior Medical Director within TFS HealthScience’s Hematology & Oncology team, you will provide top‑level medical leadership for oncology clinical studies across multiple therapeutic indications. Working remotely from Spain, Germany, Sweden, the UK, Poland or Portugal, you will ensure scientific credibility, safety oversight, and regulatory compliance for our sponsors.
Key responsibilities
- Act as medical monitor for assigned oncology studies, reviewing protocols, eligibility, dose‑modification queries and emerging safety data.
- Provide medical oversight and serve as escalation point for the broader oncology portfolio.
- Review safety sections of study protocols, Investigator’s Brochures, adverse event listings, laboratory data, vital signs and ECGs.
- Perform senior‑level medical review of safety cases, cumulative listings, PSURs, PBRERs, DSURs and Risk Management Plans.
- Contribute medical input to regulatory documents, sponsor proposals, bid strategies and business development activities.
- Conduct literature reviews and signal‑detection activities to support safety assessments.
- Help develop and improve departmental SOPs, tools and training materials.
Required profile
- Medical degree (MD or equivalent) with extensive experience in oncology clinical research.
- Proven track record as a medical monitor or senior medical reviewer for oncology trials.
- Deep understanding of regulatory requirements and safety reporting standards.
- Strong analytical and decision‑making abilities, with the capacity to provide authoritative medical opinions.
Required skills
- Medical monitoring
- Clinical trial safety assessment
- Protocol review
- Adverse event evaluation
- PSUR preparation
- PBRER preparation
- DSUR preparation
- Risk Management Plan development
- Literature review
- Signal detection
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Published 4 weeks ago
Expires 1 month from now
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TFS HealthScience
Nzalae/ Nzawa locations
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