Senior Director, Head of Study Start Up

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

7d•$298,700 - $465,900

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 improving 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, represents it in portfolio governance, and contributes to the Clinical Delivery & Patient Centricity leadership team. It works with internal R&D functions and external service providers, including CROs, and leads organizational change as roles, processes, and ways of working evolve. The 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’ 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.
External applicants must be eligible to work in the United States; the role does not offer work-authorization sponsorship.

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 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.

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 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.