Senior Director, Head of Study Start Up

Merck•Billerica, MA

About The Position

EMD Serono is seeking an experienced clinical development leader to head its Study Start-Up Unit and provide strategic direction, operational oversight, and expert leadership across study start-up activities for the clinical development portfolio. The role focuses on accelerating country and site activation, strengthening delivery performance, and advancing how clinical trials are planned and executed. The leader works across Global Development Operations, R&D, and external partners to ensure start-up strategies are efficient, risk-based, compliant, and focused on bringing medicines to patients faster. The position leads the Study Start-Up Unit, sets its strategy, and oversees quality, performance, delivery, and accountability across studies and partners. It contributes to the Clinical Delivery & Patient Centricity leadership team and portfolio governance, influences clinical trial execution and sourcing models across Phase I–IV studies, and builds networks across R&D functions and external service providers. The role also leads organizational change as roles, responsibilities, processes, and working practices evolve. This role does not offer work authorization sponsorship. External applicants must be eligible to work in the United States.

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.
At least 5 years of direct people leadership experience 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.

Nice To Haves

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 commitment to improving the speed, quality, and experience of clinical research.
Collaborative and inclusive approach, with an ability to build trust across functions, regions, and external partnerships.
Curiosity and an improvement-oriented mindset, with an ability to turn new ideas, data, and technologies into practical operational solutions.
Resilience and adaptability in a changing environment, with an ability to lead through ambiguity and organizational change.

Responsibilities

Lead the Study Start-Up Unit and set strategic direction for clinical study start-up activities across the clinical portfolio.
Provide operational oversight based on quality, performance, and delivery trends, ensuring 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 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 agreements with institutions, healthcare professionals, and healthcare organizations related to clinical trials are negotiated and executed in accordance 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 oversee 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.
Stay current with industry standards, emerging technologies, and innovative approaches relevant to clinical operations.
Lead organizational change, integrating new roles, responsibilities, processes, and ways of working as the organization evolves.