COCO-0, Director Clinical Operations

EMD Serono Research & Development Institute•Billerica, MA

5d•Hybrid

About The Position

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.

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)
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