Associate Director at Verastem Oncology overseeing phase 3 global clinical trial. Leading operational execution and compliance with regulatory guidelines for oncology - focused studies.
About the role
- AD/Director, Clinical Operations responsible for overseeing clinical programs at BridgeBio Pharma. Leading cross-functional teams to ensure successful execution of clinical trials.
Responsibilities
- Represent Clinical Operations at the Clinical Development Team, cross-functionally and/or Global Program Team
- Study Planning and Management; Establish and coordinate all on-going study management activities, including leading the cross-functional study team to develop an overall study execution plan to deliver on key study deliverables
- Partners closely and effectively with other functions and functional heads to drive program forward
- Demonstrates ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking, metrics and reporting activities
- Assists and management of CRO/vendor(s) Scopes of Work (SOW), scope changes, budgets, and vendor payments; creating and tracking on all clinical study budgets
- Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors
- Contributes to building the organization
Requirements
- BA/BS required in a scientific / medical field, or equivalent work experience
- At least 10+ years of experience in managing global clinical trials at all stages of development within the biopharma industry
- Significant experience with cross-functional leadership and clinical teams, including leading data review, database lock and study reporting activities
- Significant experience with BLA prep; FDA submissions and FDA audit prep and readiness
- Experience in Quality Assurance, SOP and study plan writing, CAPA preparation and closure
- Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
- Strong leadership ability and character to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment
- You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
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