Senior Director, Global Clinical Research – ITP

JobtailorWorkFromHome

Stellenbeschreibung:

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.