Senior Medical Director - Trial Form Support

Trial Form Support; Barcelona; Presencial; EUR 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation package

Personal and professional growth

Collaborative and innovative环境

Descripción de la vacante

Trial Form Support seeks a Senior Medical Director to lead oncology/hematology medical strategy, provide hands-on monitoring for trials, and oversee portfolio-level medical oversight. The role involves shaping development plans, safety reviews, and sponsor communications in a dynamic, international team.

The successful candidate will have MD with specialist training and 10+ years post-qualification experience, with 7+ years in oncology/hematology clinical development and proven ability to

Formación

• MD with specialist medical training and 10+ years post-qualification experience
• 7+ years in oncology/hematology clinical development
• Hands-on medical monitor experience in oncology trials
• Experience on safety data review boards or equivalent
• Strong knowledge of ICH, GCP, Pharmacovigilance and SOPs
• Excellent written and verbal communication in fast-paced, international environments
• Willingness to travel internationally
• Ability to work in a fast-paced environment
• Medical monitoring in oncology trials
• Safety data reviews (AEs/SAEs)

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, Investigator's 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

Conocimientos

Medical monitoring

Oncology trials

Safety data review

ICH/GCP/PV/SOPs

Clinical development

Stakeholder engagement

Regulatory documents

Communication

Travel readiness

AEs/SAEs review

Educación

MD with specialist medical training

Descripción del empleo

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.

• competitive compensation package
• opportunity for personal and professional growth
• collaborative and innovative environment
• 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, Investigator's 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
• 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
• ability to work in a fast-paced environment
• medical monitoring in oncology trials
• safety data reviews (AEs/SAEs)

Senior Medical Director - Trial Form Support barcelona, catalunya, es