Denise Lee · Biopharmaceutical Executive & Strategic Advisor · Munich
Connecting science, strategy and leadership.
I help biopharmaceutical companies and CROs navigate their next stage of development and growth, drawing on international executive experience across biotech, pharmaceutical companies and CRO management.
Executive MBA · Lecturer, ESCP Business School
Executive profile
Experience on different sides of the clinical development table.
I began as a healthcare professional, working with patients in Canada and London before moving into clinical research and industry. Over more than 25 years, I have contributed to protocol development, clinical execution and clinical quality assurance, as well as supply chain and procurement.
My career has given me experience of both the sponsor and CRO sides of the industry, encompassing business development, compliance and the regulatory landscape. As a CRO Managing Director and a clinical operations leader in pharmaceutical and biotech companies, I have built teams, strengthened organisations and helped turn development strategy into action.
My Executive MBA at ESCP Business School complements this experience with expertise in managing people and organisations, organisational strategy and corporate strategy. I also lecture in ESCP’s MSc in Biopharmaceutical Management, connecting the business of clinical development with cross-cultural leadership, governance and storytelling.
I bring these perspectives to the table by listening, understanding the bigger picture and helping people find a clear way forward. My particular interest is helping emerging biopharmaceutical companies and CROs navigate their next stage of development and growth.
Expertise
Leadership for the next stage.
Executive leadership
Executive, interim & fractional leadership
Leadership through growth and change, bringing organisational structure, people and partnerships together around development priorities. Experience relevant to COO, Chief Strategy Officer and co-Managing Director mandates.
Strategic advisory
Strategic advice & organisational readiness
An experienced perspective for founders, investors and leadership teams on development strategy, organisational readiness and cross-cultural collaboration. I bring experience on advisory committees and boards and welcome further roles in both.
Clinical development
Clinical development and operations consulting
Clinical leadership across countries and cultures, from protocol development and CRO selection and oversight to inspection readiness. Team development, mentoring, change management and cross-cultural collaboration training.
Particular interests: allergy, immunology, rare disease, oncology and innovative therapeutics.
Leadership in practice
Building organisations. Bringing people together.
$2M+
USD saved within six months
Vendor renegotiation and operational efficiencies, supported by stronger governance.
1,000+
Patients in under six months
International patient recruitment for a large allergy clinical trial.
12 weeks
From long-list to signed agreement
“From Chaos to Clarity”: a structured, data-driven approach to CRO selection.
- Vice President Clinical OperationsOncology biotech, radiopharmaceuticalsNuclidium
- Vice President Clinical OperationsAntibody-drug conjugates in oncologyHeidelberg Pharma
- Head of International Clinical OperationsInterim leadership; 32 staff across five countriesJCR Pharmaceuticals
- Managing DirectorContract research organisation, MunichMetronomia
- Head of Clinical OperationsBuilt a 24-person team across four countriesAllergy Therapeutics
Education & teaching
Executive MBA
ESCP Business School
Lecturer
MSc in Biopharmaceutical Management
ESCP Business School
Professional Agile Leadership certification
Chief Data Officer certificate
Diploma in Pharmaceutical Medicine
University of Basel
Bachelor of Science in Rehabilitation Medicine
University of British Columbia
- Metronomia
Organisational development and business growth
As Managing Director, I translated insights from more than 60 staff interviews into focused organisational improvements. Clearer responsibilities, stronger accountability and investment in tools and leadership improved efficiency and supported an expanded customer base, new contracts and continued client renewals.
- JCR Pharmaceuticals
International team integration and development
My interim leadership remit expanded to 32 staff across the US, Brazil, Japan, the UK and Germany. Through on-site listening and a shared team vision, I introduced a matrix structure with clearer study ownership, backup responsibilities and opportunities for international development. These changes improved job satisfaction and earned positive feedback from executive leadership.
- Allergy Therapeutics
Building a global clinical operations function
I expanded a small German team into a 24-person clinical operations organisation across Germany, the UK, Spain and the US. This created capacity to support an extensive development programme in response to changing regulatory requirements. I also contributed to company-wide initiatives in organisational values, people systems and performance management.
Connect
The right experience at your table.
Whether you need someone to lead your next stage, strengthen your team or contribute an independent perspective, I would welcome a conversation about the role I could play.
Professional email
Address to be confirmed before launch
Based in
Munich, Germany