Senior Director, Compound Operational Lead
Company: emd serono
Location: Billerica
Posted on: March 21, 2026
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Job Description:
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. Thats
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. Your Role: The Compound Operational Lead (COL) is a global
strategy program-level role within Global Development Operations
(GDO). The COL will provide operational oversight, leadership and
strategic input for the planning and execution of clinical
program(s). In close partnership with cross-functional teams the
COL will lead the clinical program, from First-in-human (FiH) to
the final launch of the asset. The COL will drive faster, cost
efficient, patient-centric trials that follow benchmarked industry
standards that utilize “state-of-the-art” clinical project
management methodologies aligned to global drug development
processes. This role is accountable for the successful preparation
and presentation of operational content at key governance
discussions, ensuring critical operational input is provided to
drive comprehensive, strategic, and thoughtful discussions for
assigned program(s). Key Accountabilities: • Leads the development
of the clinical operational strategy (comprising of multiple
trials, and/or multiple indications) and delivers the clinical
development plan within the budget, timelines and quality standards
agreed upon by Governance Committees. • Represents GDO within the
Global Program Team (GPT) and serves as the key GDO operational
point of contact for the program. • Accountable for the successful
preparation and presentation of operational content at key
governance discussions (Development Unit (DU), Program & Portfolio
Governance (PPG), Integrated Protocol Review Committee (iPRC),
Research & Development Committee (R&DCM), etc). • Key
contributor to the development of annual program objectives and
communicating to relevant line management. • Drives and leads the
successful execution of all operational components of (a) global
clinical program(s) using strong project management, leadership,
and organizational skills. • Ensures strong oversight, review, and
quality delivery of program CAPAs to meet corporate compliance
standards and timelines. • Provides expert leadership and
contribution to all operational aspects of the program budget,
including oversight of individual trial budgets and forecasts to
ensure delivery within the R&D financial standards. • Performs
high-level review and provides input in the development of key
clinical trial documents such as protocols and Clinical Study
Reports (CSRs) and contributes to and/or reviews compound level
documents such as Investigator Brochures, DSURs, briefing books. •
Provides guidance and leadership support to Global CTLs and other
cross-functional members within the assigned program/project. •
Filters, prioritizes, analyzes, and validates complex and dynamic
information from a diverse range of external and internal sources
to respond to technical operation and organizational challenges. •
Supports the development and implementation of department
initiatives including input on certain SOPs, processes, and
workstreams. • Manages large, diverse projects with high or even
unique complexity. Leads a large diverse project team with members
from multiple functions and a broad span of levels and roles or
even disciplines. • Accountable for successful project execution
and organizational learning. Controls sizable resources and works
independently. Also defines team organization, roles, and
responsibilities as well as budget. Strategic Impact: • Contributes
to the overall strategic decisions for a program(s) and drives the
clinical operations aspects of the strategy within the
cross-functional program team and various clinical sub-teams. •
Develops innovative clinical operation strategies (including
patient access and feasibility plans) across multiple indications,
trials, and geographies. • Leverages strategic knowledge and serves
as subject matter expert across TA portfolio for current drug
development/clinical trial management processes, regulations, and
therapeutic knowledge. Matrix Management of People: • Leads the
Clinical Operations Team (and potentially multiple teams or a
sizable team of professionals/managers/team leaders) and is
accountable for the performance and results of the team within a
matrix environment internally and externally. • Assess resource
needs and makes recommendations for allocations across the
program(s). Contributes to setting team member objectives,
coaching, and developing employees, performance appraisal feedback.
Who You Are Minimum Qualifications: • Candidate must have a minimum
of a BA or BS degree; Advanced degree in Life Sciences (such as a
graduate degree) (e.g., Biology, Chemistry, Pharmaceuticals)
preferred or equivalent medical background. • At least 12-15 years
of direct experience with independently leading and managing very
complex global clinical trial program(s) across multiple
indications in the pharmaceutical industry plus 5-7 years in a
senior leadership position directing the operations of a
large-scale global team and developing and mentoring
junior/mid-level team members in matrix environment. • Requires
extensive project management experience in potentially diverse
project settings. Also requires (considerably) deep and broad
expertise combined with in-depth knowledge of competitors as well
as challenges and developments in the industry to achieve
objectives and to identify business opportunities. Preferred
Qualifications: • Strong leadership competencies and influencing
skills with senior leaders and cross functional leaders. •
Effective oral and written communication skills to influence,
inform and guide a large scale global operational team. • Broad
clinical operations experience and strong project management skills
• Proven teambuilding skills and ability to foster partnerships
across projects and multidisciplinary teams. • Comprehensive
expertise in drug development, including profound knowledge of
interfaces and interdependencies of clinical development with other
functions (e.g. nonclinical & pharmaceutical development,
regulatory, commercial/ marketing) Other Requirements: This
position is hybrid, requiring regular onsite presence (typical
schedule: 3 days in office and 2 days remote).
Keywords: emd serono, Worcester , Senior Director, Compound Operational Lead, Healthcare , Billerica, Massachusetts