Denise Lee

Vice President Clinical Operations @Heidelberg Pharma AG

Ladenburg, DE

As Vice President of Clinical Operations at Heidelberg Pharma, I am responsible for driving the strategic direction, execution, and operational excellence of the company’s clinical development programs. My role encompasses: Leadership & Strategy: Overseeing global clinical operations strategy to ensure the efficient execution of Heidelberg Pharma’s portfolio and aligning clinical trial activities with corporate objectives and regulatory requirements. Operational Execution & Oversight: Managing the end-to-end clinical trial process, from feasibility to study completion, while ensuring high-quality vendor oversight, risk management, and adherence to Good Clinical Practice (GCP). Cross-Functional Collaboration & Innovation: Working closely with regulatory, medical, quality, and commercial teams to optimize trial design and execution, while driving inspection readiness, data governance, and digital transformation in clinical trial operations. People & Organizational Development: Building and leading a high-performing global team, fostering a culture of innovation, accountability, and collaboration, while supporting team development through mentoring, training, and process improvements. Regulatory & Compliance Excellence: Ensuring alignment with EMA, FDA, and global regulatory authorities for clinical development programs by maintaining rigorous compliance and risk mitigation strategies to uphold patient safety and data integrity.With over 25 years of global clinical research experience, I am passionate about leading teams, optimizing operations, and advancing Heidelberg Pharma’s mission to bring transformative therapies to patients. Excited to embark on this new journey!

The University of British Columbia

Bachelor of Science - BSc Rehabilitation Medicine

ESCP Business School

Executive Master of Business Administration - EMBA

University of Basel

Diploma of Advanced Studies