16 sep
|
Trial Form Support
|
Barcelona
16 sep
Trial Form Support
Barcelona
Overview In this role you will provide senior medical leadership in oncology/hematology, combining hands-on medical monitoring with portfolio-level medical oversight to uphold scientific credibility for sponsors. You will ensure medical input across study designs, safety reviews, and regulatory documents, while supporting business development and sponsor engagement. You'll shape medical strategy for the oncology portfolio and represent the company at scientific forums.
This position offers a chance to influence clinical development at scale within a collaborative, innovation-driven team.
Compensaciones / Incentivos competitive compensation package comprehensive benefits opportunity for personal and professional growth collaborative and innovative environment
Responsabilidades
Act as medical monitor for assigned oncology studies and oversee protocol-related medical reviews and safety data interpretation
Provide escalation-level medical oversight across the oncology portfolio and advise on study design and measurements
Review safety components of protocols, Investigators Brochure, and clinical trial reports from a safety perspective
Assess adverse events (AEs/SAEs) and contribute to PSURs, PBRERs, DSURs, and Risk Management Plans
Contribute to regulatory documents and literature review; participate in SOP development and staff education
Represent the company as a senior scientific voice in targeted indications; engage with KOLs and investigators
Build and maintain sponsor relationships, support bid strategy and defense meetings, and translate science into credible sponsor messaging
Coordinate with Business Development and leadership teams to shape oncology strategy and service offering
Requisitos principales MD with specialist medical training
10+ years of post-qualification medical experience
7+ years in oncology/hematology clinical development
Hands-on medical monitor experience in oncology trials
Experience on safety data review boards or equivalent
Understanding of ICH, GCP, Pharmacovigilance, and internal SOPs
Excellent written and verbal communication; able to work in fast-paced, international environment
Willingness to travel internationally excellent communication ability to work in a fast-paced environment stakeholder management medical monitoring in oncology trials safety data reviews (AEs/SAEs)
PSURs, PBRERs, DSURs
📌 Senior Medical Director (Barcelona)
🏢 Trial Form Support
📍 Barcelona