Senior Director, Global Clinical Research – ITP

Jobtailor; Deutschland; Remote; EUR 140.000 - 180.000; Vollzeit

Zusammenfassung

Baxter is seeking a senior scientific leader to drive evidence-generation programs across Infusion Therapies & Technologies. You will translate clinical priorities into executable study designs and work in close collaboration with Medical Affairs to align evidence strategies with regulatory and market needs.

The role requires leading a Clinical Operations team, guiding study delivery, and ensuring scientific rigor while balancing operational feasibility. Global regulatory awareness is essential.

Qualifikationen

• Advanced scientific or clinical degree required.
• Minimum 10 years of experience in clinical research, clinical development, medical affairs, or evidence generation.
• Experience leading development and execution of clinical studies and evidence-generation programs.
• Experience working within regulated healthcare environments.
• Strong understanding of GCP, global regulatory expectations, and evidence-generation requirements.
• Ability to build trusted partnerships across Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, HEOR, Commercial, and Quality.

Aufgaben

• Serve as the scientific leader for Baxter's Infusion Therapies & Technologies portfolio.
• Transform medical, clinical, and business priorities into executable evidence-generation strategies.
• Partner with Medical Affairs to convert medical evidence priorities into integrated clinical research strategies.
• Design evidence-generation programs addressing unmet clinical, scientific, healthcare system, and customer needs.
• Lead the Clinical Operations team and optimize feasibility, execution quality, enrollment strategies, and study delivery.
• Support study execution through emerging-data interpretation and resolution of scientific issues.
• Support innovation, product development, regulatory submissions, post-market evidence generation, and value-based healthcare initiatives.

Kenntnisse

Clinical Research Methodology

Evidence Generation

Stakeholder Engagement

Study Design

GCP Knowledge

Leadership

Ausbildung

MD/PhD/Equivalent

Jobbeschreibung

Responsibilities

• Serve as the scientific leader for Baxter's Infusion Therapies & Technologies portfolio
• Transform medical, clinical, and business priorities into executable evidence-generation strategies
• Partner with Medical Affairs to convert medical evidence priorities into integrated clinical research strategies
• Design evidence-generation programs addressing unmet clinical, scientific, healthcare system, and customer needs
• Develop fit-for-purpose study designs and research plans for clinicians, regulators, payers, providers, and healthcare systems
• Lead expertise in clinical research methodology and scientific study design
• Apply epidemiology, biostatistics, implementation science, health-services research, and clinical study methodologies
• Provide scientific oversight for protocols, statistical plans, clinical study reports, and evidence interpretation
• Ensure scientific rigor across clinical research activities
• Lead the Clinical Operations team and optimize feasibility, execution quality, enrollment strategies, and study delivery
• Balance scientific rigor, operational feasibility, project timelines, and resource requirements
• Participate in governance and risk mitigation for ongoing studies
• Support study execution through emerging-data interpretation and resolution of scientific issues
• Support innovation, product development, regulatory submissions, post-market evidence generation, clinical practice adoption, and value-based healthcare initiatives

Requirements

• Advanced scientific or clinical degree (MD, PharmD, PhD, DNP, or equivalent)
• Minimum 10 years of experience in clinical research, clinical development, medical affairs, or evidence generation
• Experience leading development and execution of clinical studies and evidence-generation programs
• Experience working within regulated healthcare environments
• Strong understanding of GCP, global regulatory expectations, and evidence-generation requirements
• Experience generating evidence across clinical outcomes, safety, workflow efficiency, human factors, usability, implementation science, real-world evidence, and health economic outcomes
• Ability to build trusted partnerships across Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, HEOR, Commercial, and Quality
• Ability to align diverse stakeholders around a common research vision
• Deep understanding of clinical research methodology
• Ability to design innovative evidence-generation approaches across pharmaceuticals, devices, and healthcare technologies
• Ability to adapt rapidly to evolving portfolio priorities
• Ability to operate effectively in ambiguity and changing business environments
• Entrepreneurial mindset
• Comfortable building new capabilities and processes
• Bias toward action and execution
• Willingness to challenge traditional approaches to accelerate learning and impact
• Ability to balance innovation with scientific rigor
• Willingness to travel approximately 25% of the time
• Strong business acumen and impeccable integrity

Core Competencies

Demonstrates expertise in clinical research methodology, evidence generation, and regulatory compliance, with a strong ability to design and execute innovative clinical studies. Proven track record in leading cross-functional teams and building partnerships across diverse stakeholders in the healthcare sector.

Highest-signal resume keywords

• Clinical Research Methodology
• Evidence Generation Programs
• Regulatory Compliance (GCP)
• Stakeholder Engagement
• Clinical Study Design

ATS Optimization Keywords

Hard Skills

• Clinical Research
• Biostatistics
• Epidemiology
• Implementation Science
• Health-Services Research
• Study Design
• Statistical Analysis
• Evidence Interpretation
• Clinical Operations Leadership
• Regulatory Submissions

Soft Skills

• Entrepreneurial Mindset
• Adaptability
• Trusted Partnership Building
• Bias Toward Action
• Impeccable Integrity

Certifications & Qualifications

• Advanced Scientific or Clinical Degree (MD, PharmD, PhD, DNP)

Industry Keywords

• Healthcare Technologies
• Clinical Development
• Medical Affairs
• Real-World Evidence
• Value-Based Healthcare
• Clinical Outcomes
• Human Factors
• Usability
• Workflow Efficiency
• Health Economic Outcomes