Open to opportunities

Chiara Merlini

@chiaramerlini

Message

Global R&D and Clinical Operations executive driving quality, compliance, and operational excellence.

Switzerland

Message

What I'm looking for

I seek senior roles where I can lead global clinical and quality strategies, drive operational transformation, mentor teams, and ensure inspection-ready, patient-focused development.

I am a results-driven global R&D, clinical operations and quality executive with over 20 years of experience leading innovative medicines, biosimilars, and strategic quality programs in top-tier matrix organizations.

I have directed large, cross-functional teams and global clinical programs from early development through marketing authorization, delivering more than 100 clinical studies and driving IND submissions and approvals.

My expertise spans clinical quality and compliance, inspection readiness, CAPA and remediation, operating model transformation, and enterprise operational excellence across therapeutic areas including neurology, oncology, hematology, gene and cell therapies.

I lead inclusively to mentor talent, embed a culture of quality and continuous improvement, and partner with senior stakeholders to translate strategy into measurable operational plans that improve organizational agility and patient outcomes.

Experience

Work history, roles, and key accomplishments

Current

Clinical Operations Therapy Area Head

Current

Alexion Pharma GmbH

Jan 2020 - Present (5 years 9 months)

Direct global clinical operations across multiple therapeutic areas, leading delivery of 100+ clinical studies and 29 programs resulting in 12 IND submissions/approvals while ensuring regulatory compliance and operational excellence.

Clinical Operations Program Management GCP IND Submission Risk Management Clinical Development

Head of Operational Excellence

Sandoz AG

Jan 2018 - Dec 2019 (1 year 11 months)

Led enterprise operational excellence for Sandoz Biopharmaceuticals, designing and implementing a next-generation operating model that improved agility, quality, and end-to-end process performance across biosimilars development.

Operational Excellence Change Management Process Optimization Governance Strategic Planning Organizational Design Regulatory Compliance Transformation

Executive Director, Operational Excellence

Novartis Pharma AG

Jan 2016 - Jan 2018 (2 years)

Spearheaded enterprise transformation initiatives within Global Drug Development, deployed eBPM and patient-centric remote trial strategies, and led integration of the GSK Oncology portfolio to deliver strategic operational improvements.

Program Management Integration Digital Strategy Stakeholder Management Operational Excellence

Principal Consultant

PA Consulting

Jan 2014 - Dec 2016 (2 years 11 months)

Led global life sciences process improvement and change programs, including a $15M GSK R&D oncology integration across 73 countries, delivering on-time integration and enhanced regulatory and operational readiness.

Consulting Program Management Change Management Clinical Quality Regulatory Affairs Integration

Executive Director, Operational Excellence

Novartis Pharma AG

Jan 2012 - Dec 2014 (2 years 11 months)

Led operational excellence for Oncology Global Development and Global Medical Affairs, implementing the AQWA audit tracking system and embedding continuous improvement to enhance audit readiness and quality oversight.

Audit Management Process Improvement Operational Excellence Stakeholder Engagement Systems Implementation Governance

Global Head Development Quality

Novartis Pharma AG

Jan 2011 - Dec 2012 (1 year 11 months)

Established and led Franchise Quality Assurance for Neuroscience, Ophthalmology and Established Medicines, delivering GCP guidance, inspection readiness and continuous improvement across global clinical portfolios.

Quality Assurance GCP Clinical Quality Risk Mitigation Process Improvement