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About the role
- 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
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