Senior Director, Head of Study Start-Up

Merck; Eysins; Presencial; CHF 240 000 - 360 000; Tempo integral

Resumo da oferta

Merck is seeking an experienced clinical development leader to head the Study Start-Up Unit, providing strategic direction and operational oversight across the portfolio.

You will accelerate country and site activation, work across Global Development Operations, R&D and external partners to ensure start-up strategies are efficient, compliant, and focused on bringing medicines to patients faster.

Qualificações

• Bachelor's degree in life sciences, healthcare, clinical research, business, or a related discipline.
• At least 10 years of relevant experience in clinical development or related field, with 5+ years in people leadership.
• Significant experience leading global study start-up across multiple therapeutic areas and phases.
• Strong knowledge of country/site activation, GCP, risk management, CRO oversight, and cross-functional operations.

Responsabilidades

• Lead the Study Start-Up Unit and set strategic direction for clinical study start-up activities across the portfolio.
• Provide operational oversight based on quality, performance, and delivery trends with clear accountability.
• Drive data-informed planning of country and site start-up activities for high-quality execution.
• Identify, assess, mitigate and communicate risks that affect timelines, quality, cost or delivery.
• Foster solution-oriented problem solving and timely escalation with external partners.
• Accelerate study start-up through process redesign, technology enablement, and continuous improvement.
• Design and implement country/site start-up strategies supporting recruitment and R&D return on investment.
• Negotiate and execute agreements with institutions and healthcare organizations in line with compliance.
• Act as senior escalation point and interface with CROs and external service providers.
• Contribute to governance and leadership teams shaping clinical delivery strategy and trial execution.

Conhecimentos

Strategic leadership

Global study start-up

Risk management

Cross-functional leadership

Data-driven planning

CRO oversight

Change management

Formação académica

Bachelor's degree in life sciences / healthcare / clinical research

Ferramentas

Predictive analytics

Clinical systems

Descrição da oferta de emprego

We are seeking an experienced clinical development leader to head the Study Start-Up Unit and provide strategic direction, operational oversight, and expert leadership across study start-up activities for the clinical development portfolio.

In this role, you will help accelerate country and site activation, strengthen delivery performance, and advance the way clinical trials are planned and executed. You will work across Global Development Operations, R&D, and external partners to ensure that start-up strategies are efficient, risk-based, compliant, and focused on bringing medicines to patients faster.

Your key responsibilities

• Lead the Study Start-Up Unit and set the strategic direction for clinical study start-up activities across the clinical portfolio.

• Provide operational oversight based on quality, performance, and delivery trends, ensuring clear accountability and ownership across internal and external partners.

• Drive data-informed planning of country and site start-up activities and promote consistent, high-quality execution across studies.

• Identify, assess, mitigate, and communicate risks and emerging issues that may affect study timelines, quality, cost, or delivery.

• Foster solution-oriented problem solving within the team and ensure timely escalation and resolution of functional or partner-related challenges.

• Accelerate study start-up and site activation through process redesign, technology enablement, and continuous improvement.

• Design and implement country and site start-up strategies that support strong recruitment performance and responsible return on R&D investment.

• Ensure that agreements with institutions, healthcare professionals, and healthcare organizations related to clinical trials are negotiated and executed in line with applicable legal and compliance requirements.

• Act as a senior point of escalation and a critical interface with contract research organizations and other external service providers.

• Represent the Study Start-Up Unit in portfolio governance and provide oversight of quality, delivery, performance, and accountability.

• Contribute to the Clinical Delivery & Patient Centricity leadership team by helping define and implement its vision and strategy.

• Influence the future direction of clinical trial execution and sourcing models to support state-of-the-art performance across Phase I-IV studies.

• Build strong networks across Global Development Operations, Global Regulatory Affairs, Clinical Trial Supplies, R&D Insights & Analytics, Patient Safety, Legal, Quality, Compliance, Finance, and other R&D functions.

• Keep current with industry standards, emerging technologies, and innovative approaches relevant to clinical operations.

• Lead organizational change effectively, integrating new roles, responsibilities, processes, and ways of working as the organization evolves.

Job requirements

• Bachelor's degree in life sciences, healthcare, clinical research, business, or a related discipline.

• At least 10 years of relevant experience in clinical development, clinical operations, study start-up, clinical trial delivery, or a closely related field and At least 5 years' experience in direct people leadership or equivalent.

• Significant experience leading global study start-up activities across multiple therapeutic areas, and clinical trial phases.

• Strong knowledge of country and site activation, clinical trial regulations, GCP, risk management, CRO oversight, performance management, and cross-functional clinical operations.

Preferred qualifications and experience

• Experience leading a global Study Start-Up function, Center of Excellence, or comparable enterprise-level clinical operations organization.

• Experience using predictive analytics, automation, artificial intelligence, clinical systems, or other technology-enabled approaches to improve country and site activation.

• Patient-focused and committed to improving the speed, quality, and experience of clinical research.

• Collaborative and inclusive, with the ability to build trust across functions, regions, and external partnerships.

• Curious and improvement-oriented, with the ability to turn new ideas, data, and technologies into practical operational solutions.

• Resilient and adaptable in a changing environment, with the ability to lead through ambiguity and organizational change.