Sr. Manager, Clinical Trial Operations Planning & Analytics
Legend Biotech USA, Trenton, NJ, United States
Legend Biotech is seeking a
Sr. Manager, Clinical Trial Operations Planning & Analytics
as part of the
Clinical Operations
team based in
Somerset ,
NJ .
Role Overview
The Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics to improve predictability and enable earlier operational intervention. The position partners closely with Clinical Operations leadership and cross‑functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.
Key Responsibilities
Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
Develop data‑driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
Build scenario models and planning outputs to support base and best case operational strategies and contingency planning.
Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
Partner with study teams, CROs, and cross‑functional stakeholders to pressure‑test trial assumptions and refine country and site strategies.
Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
Translate study and portfolio performance data into actionable insights and executive‑ready recommendations for senior leadership.
Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross‑study consistency.
Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
Perform other duties as required.
Work closely with the Sr. Director and VP of Clinical Operations, collaborating with Clinical Operations study teams, Clinical Development, IT, ITQA, Biostatistics, Regulatory, Project Management, Procurement, Finance, QA, and CRO/vendor.
Requirements
Minimum degree requirements: a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
Experience working with data sources to inform trial forecast modeling.
Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
Experience building dashboards, models, or analytics to support clinical trial execution preferred.
Oncology, cell therapy, or early‑phase clinical development experience preferred.
Ability to travel as necessary (approximately 10%).
Knowledge/familiarity with tools to enable trial forecasting and modeling.
Strong critical thinking, analytical, strategic planning, and problem‑solving skills.
Effective oral, written, and interpersonal communication skills with strong presentation capability.
Forward and critical thinker with ability to translate data into decisions.
Strong organizational and project management skills and the ability to multitask.
Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
Working knowledge of GCP, FDA, and ICH Guidelines.
Benefits
These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.
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Sr. Manager, Clinical Trial Operations Planning & Analytics
as part of the
Clinical Operations
team based in
Somerset ,
NJ .
Role Overview
The Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics to improve predictability and enable earlier operational intervention. The position partners closely with Clinical Operations leadership and cross‑functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.
Key Responsibilities
Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
Develop data‑driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
Build scenario models and planning outputs to support base and best case operational strategies and contingency planning.
Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
Partner with study teams, CROs, and cross‑functional stakeholders to pressure‑test trial assumptions and refine country and site strategies.
Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
Translate study and portfolio performance data into actionable insights and executive‑ready recommendations for senior leadership.
Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross‑study consistency.
Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
Perform other duties as required.
Work closely with the Sr. Director and VP of Clinical Operations, collaborating with Clinical Operations study teams, Clinical Development, IT, ITQA, Biostatistics, Regulatory, Project Management, Procurement, Finance, QA, and CRO/vendor.
Requirements
Minimum degree requirements: a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
Experience working with data sources to inform trial forecast modeling.
Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
Experience building dashboards, models, or analytics to support clinical trial execution preferred.
Oncology, cell therapy, or early‑phase clinical development experience preferred.
Ability to travel as necessary (approximately 10%).
Knowledge/familiarity with tools to enable trial forecasting and modeling.
Strong critical thinking, analytical, strategic planning, and problem‑solving skills.
Effective oral, written, and interpersonal communication skills with strong presentation capability.
Forward and critical thinker with ability to translate data into decisions.
Strong organizational and project management skills and the ability to multitask.
Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
Working knowledge of GCP, FDA, and ICH Guidelines.
Benefits
These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.
#J-18808-Ljbffr