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COCO-0, Director Clinical Operations

 

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

 

Key Accountabilities:

Operational Strategy & Program Leadership

  • 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

 

Risk Management & Delivery

  • 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

 

Stakeholder & Cross-Functional Leadership

  • 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

 

Matrix Leadership & Talent Development

  • 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

 

Core Competencies:

  • Program Management: Leads global, multi-trial programs with complex operational and strategic dimensions; expert in risk management, budgeting, and scenario planning
  • Operational Leadership: Drives execution excellence across cross-functional, matrixed teams; holds self and others accountable to high performance standards
  • Stakeholder Influence: Communicates and influences effectively at all levels of the organization; builds alignment and drives decisions in ambiguous, fast-moving environments
  • Patient & Science Focus: Maintains unwavering focus on patient centricity and scientific integrity as the foundation of all operational decisions
  • Talent Development: Inspires and develops clinical operations talent; fosters a culture of continuous learning, accountability, and growth

 

 

Who You Are

Minimum Qualifications:

  • 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)

 

Preferred Qualifications:

  • 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

 

Pay range for this position: $173,000 - $259,000

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. For more information click here

 

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!

 

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

 

Job Requisition ID:  297577
Location:  Billerica
Career Level:  E - Professional (10+ years)
Working time model:  Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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