Senior Manager leading Global Trial Optimization focusing on clinical development strategy, feasibility processes, and external expert relationships for a biotechnology company.
Responsibilities
Lead program or study level activities advising on clinical development strategy, study concepts, protocols and operational plans
Develop and maintain relationships with external experts facilitating intelligence used in study design
Lead study level feasibility processes to generate timely data to inform study design
Partner with teams during CRO led feasibility activities supporting validation of enrollment rates and study start up timelines
Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management
Partner with Data and Analytics function to review and identify appropriate central data sources
Articulate the data story to teams based on country level feasibility to support data driven decisions
Project management of study level country landscape assessment activities
Lead study level engagements to acquire, analyze and deliver high quality targeted information from external partners
Prove input into continuous improvement activities to ensure consistency of process execution
Develop and implement patient recruitment and retention tactics aligned with defined study strategy
Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
May require up to 20% travel
Requirements
Bachelors degree in a related field
minimum of 8 years of relevant industry experience within pharma/biotech, a CRO or consulting
Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval
Experience in using data to inform clinical strategy development
Ability to understand sophisticated business questions and develop effective solutions
Experience in process development, implementation and change management activities
Line management experience preferred
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels
Job title
Senior Manager – Global Partnerships, Trial Optimization
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