COCO-0, Director Clinical Operations

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

7d•Hybrid

About The Position

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. Location: The COCO-0, Director Clinical Operations is a hybrid position located in the Boston area (Billerica). There will be minimal travel, possibly domestic and international, to meet business needs. Your Role: The Compound Operation Lead (COL) is a global role within Global Development Operations (GDO), which is accountable for the operational leadership and delivery of one or more clinical program(s) from First-in-Human (FiH) through to launch. The COL serves as the GDO representative on the Global Program Team (GPT) and is the single point of operational accountability for translating asset strategy into executable clinical programs. Partnering with Global Program Teams, Clinical Trial Leads (CTLs), and cross-functional R&D functions, the COL drives patient-centric trial delivery within budget, timelines, and quality standards aligned to industry benchmarks. Why This Role Matters? Enables faster patient access by reducing clinical program cycle times through operational excellence Ensures audit-ready governance and compliance with GCP and ICH standards Drives cost efficiency and delivery performance vs. industry benchmarks Builds organizational capability in clinical operations leadership across global programs

Requirements

Advanced degree in life sciences, pharmacy, medicine, or related field (PhD, PharmD, or MD preferred)
10+ years of progressive experience in clinical drug development within the pharmaceutical or biotech industry
Proven track record of leading complex, global clinical programs across multiple phases and therapeutic areas
Demonstrated experience representing clinical operations at senior governance forums (e.g., Program Review Committees, R&D leadership meetings)

Nice To Haves

Deep knowledge of GCP, ICH guidelines, and global regulatory requirements
Strong financial acumen; experience managing program-level budgets of significant scale
Proficiency in clinical operations tools, systems, and performance metrics frameworks

Responsibilities

Develops and executes operational strategy for assigned clinical program(s), translating asset strategy into executable plans that connect science, operations, and patient outcomes
Leads program-level operational execution using disciplined project management principles, ensuring delivery within budget, timelines, and quality standards across multiple trials and indications
Serves as GDO representative on the GPT; provides operational input into asset strategy, governance decisions, and lifecycle planning
Accountable for preparation and presentation of operational content at key governance forums
Identifies and evaluates program-level operational risks; develops and implements mitigation strategies and contingency plans to ensure delivery of asset strategy and governance milestones
Ensures strong oversight, quality delivery, and resolution of program-level CAPAs and audit findings
Monitors program-level KPIs and operational metrics; drives corrective action where performance deviates from plan
Influences cross-functional leaders and senior management to align on operational priorities; negotiates resource allocation, timelines, and trade-offs to achieve program objectives
Partners with Finance, DU, and GDO leadership to develop, track, and optimize program budgets across the full portfolio of trials within assigned program(s)
Builds and maintains effective working relationships with internal and external stakeholders including CROs, vendors, and regulatory partners
Provides matrix leadership of Global CTLs within assigned program(s); accountable for team performance, resource allocation, objective-setting, and coaching within matrix structure
Builds and develops a pipeline of clinical operations talent through mentoring, coaching, and performance management
Identifies high-potential team members and creates development opportunities aligned to organizational capability needs