Sr. Project Director, Evidence Development Solutions - Oncology
New
Fully remote work opportunity within the United States.Full-TimeDirector
SalaryCompetitive salary package.
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Job Details
- Experience
- 15–20 years of clinical research operations experience; 15 years of progressive project management or clinical operations leadership; 8 years of people management.
- Required Skills
- Project ManagementBudget managementHIPAA
Requirements
- Bachelor's degree in Life Sciences, Healthcare, Business, or a related discipline (Master's or Ph.D. preferred).
- Minimum of 15–20 years of clinical research operations experience within a CRO, pharmaceutical, biotechnology, or medical device environment.
- At least 15 years of progressive project management or clinical operations leadership experience.
- Minimum of 8 years of people management and supervisory experience.
- Strong expertise in oncology and biotechnology clinical research.
- Comprehensive understanding of clinical development, evidence generation, real-world evidence (RWE), Phase II-IV studies, and global clinical research operations.
- In-depth knowledge of ICH-GCP, FDA, EMA, GDPR, HIPAA, and other international regulatory standards.
- Demonstrated experience managing complex global clinical programs, budgets, resource planning, and operational strategy.
- Experience supporting proposals, pricing models, business development initiatives, and client presentations.
- Proficiency with Microsoft Office and project management tools.
- Willingness to travel approximately 10% as business needs require.
Responsibilities
- Lead the planning, execution, and delivery of multiple global oncology and evidence development projects.
- Provide strategic leadership, guidance, and mentorship to Project Managers and multidisciplinary teams.
- Oversee project timelines, budgets, financial forecasting, revenue recognition, invoicing, and overall program profitability.
- Build and maintain strong client relationships as the primary senior operational contact.
- Identify project risks, develop mitigation strategies, and ensure effective risk management throughout the lifecycle.
- Ensure compliance with ICH-GCP, FDA, EMA, GDPR, and HIPAA.
- Contribute to business development, including proposal development, budget planning, and bid defenses.
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