Senior Director, Head of Study Start Up

EMD Serono, Inc.; Billerica (MA); On-site; USD 299,000 - 466,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

EMD Serono, Inc. is seeking an experienced clinical development leader to head the Study Start-Up Unit and guide strategic direction across the portfolio.

You will accelerate country and site activation, oversee quality and delivery, manage CRO relationships, and drive risk-based, compliant start-up strategies to shorten timelines for Phase I–IV trials.

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related discipline.
• At least 10 years in clinical development, clinical operations, study start-up, or related field and 5+ years in direct leadership.
• Experience leading global study start-up across multiple therapeutic areas.
• Strong knowledge of country/site activation, clinical trial regulations, GCP, risk management, CRO oversight, performance management, and cross-functional operations.

Responsibilities

• Lead the Study Start-Up Unit and set strategic direction for start-up activities across the portfolio.
• Provide operational oversight based on quality and delivery trends with clear accountability across partners.
• Drive data-informed planning of country/site start-up activities and ensure high-quality execution.
• Identify, assess, mitigate, and communicate risks affecting timelines, quality, or cost.
• Accelerate start-up and site activation through process redesign, tech enablement, and continuous improvement.

Skills

People leadership

Global start-up

Clinical operations

GCP knowledge

Risk management

Cross-functional collaboration

Strategic planning

Communication

Education

Bachelor's degree

Tools

AI-enabled systems

Automation

Predictive analytics

Clinical trial systems

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

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.

Required

• 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.

Pay Range for this position: $298,700-$465,900

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!