Director/Sr. Director, Clinical Operations - Oncology Programs
$185,000–$250,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Develop clinical operational strategy and execute oncology programs on-time, within budget, and to company objectives. Translate program strategy into operational execution by developing clinical operations plans and connecting science with business and patients. Identify and evaluate program-level risks and mitigations while managing external budgets and vendor oversight. Interact with cross-functional leaders and CROs to achieve program goals, representing Clinical Operations in meetings. Review clinical and regulatory documents to ensure compliance with ICH/GCP standards and global regulations. Drive activities and solutions to deliver on program milestones from initiation through completion across multiple phases. Based in the Boston Seaport office with onsite presence required minimum 2 days per week.
Required Qualifications
- Bachelor's degree or work experience equivalent required, preferably in a scientific field
- 10+ years of Biotech/Pharma clinical research related experience, at a Director or Senior Director level of scope and seniority
- Strong vendor management and oversight experience
- Strong experience in oncology
- Proven ability working on a global team in the management and completion of multiple, complex clinical studies
- Competent in application of standard business procedures (SOPs, ICH, global regulations, ethics and compliance)
- Integral participation in initiatives or advancement strategies for clinical operations
- Experience in successful study initiation through study completion, and in multiple phases of studies (Phases 1-3)
- Strong communication and stakeholder management skills
- Boston-based, with willingness to be onsite in our Seaport office a minimum of 2 days per week
- Legally authorized to work in the United States
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