Senior Manager, Clinical Science
Location
United States
Posted
4 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
The Senior Manager – Clinical Science will support BeOne Clinical and Medical assets in the successful execution of clinical development programs and deliverables working in partnership across the organization.
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Facilitate the generation of, update, and/or review key documents, including, but not limited to:
- Protocol concepts, synopses, protocols, and amendments
- Informed Consent documents; Investigator Brochures; clinical study reports
- Abstracts, posters and manuscripts
- Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Developmental Safety Update Reports, Health Authority briefing documents, Orphan Drug applications, and annual reports
- Risks / benefits analysis for applicable documents
- Assist with clinical development tasks pertaining to study start up, maintenance, and closeout activities
- Partner with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies
- Support Clinical Operations in clinical trial budget planning and management
- Contribute to or perform therapeutic area/indication research and competitor analysis
- Review, query, and analyze clinical trial data
- Interpret, and present clinical trial data both internally and externally
- Provide scientific support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
- Create clinical study or program-related slide decks for internal and external use
- Develop, track, execute and report on goals and objectives
- Be accountable for compliant business practices
Managerial Responsibilities
- None
Qualifications
- PharmD; or PhD within a clinical and/or scientific profession; MD (or equivalent)
- Minimum of 3+ years relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent
Travel
- Approximately 25% of work may involve domestic and/or international travel
Global Competencies
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range
$141,800.00 - $186,800.00 annually
Benefits
- Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Equal Opportunity Employer
BeOne is committed to fair and equitable compensation practices. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
Job Requirements
- PharmD; or PhD within a clinical and/or scientific profession; MD (or equivalent)
- Minimum of 3+ years relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent
- Travel
- Approximately 25% of work may involve domestic and/or international travel
- Global Competencies
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
- Salary Range
- $141,800.00 - $186,800.00 annually
Benefits
- Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
- Equal Opportunity Employer
- BeOne is committed to fair and equitable compensation practices. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.