Senior Director, Clinical Science
Skills
- Proven experience in oncology clinical trials and immunotherapy
- Clinical development strategy and program oversight
- Protocol authoring and regulatory document preparation
- Safety monitoring and medical review
- Clinical data review, cleaning, analysis, and interpretation
- Cross-functional leadership and stakeholder management
- Understanding of trial design and statistics
- Experience with DMC operations and meeting execution
Responsibilities
- Partner with cross-functional program teams to create and refine clinical development plans and strategy for oncology candidates.
- Provide clinical support for study conduct including feasibility, data management coordination, safety/medical monitoring, and study updates.
- Perform medical and safety/efficacy data reviews and prepare clear summaries of trial results.
- Identify and assess issues related to study conduct or subject safety and collaborate on resolution strategies.
- Support and operationalize data review committees (DMCs), prepare meeting materials and data reports, and execute meetings.
- Author and contribute to clinical and regulatory documents including protocols, study reports, IBs, and ICFs.
- Engage with study sites, vendors, KOLs, and regulatory bodies to support program objectives and regulatory interactions.
- Serve as recognized clinical expert for assigned programs and lead development of abstracts, posters, and scientific content.
Education
- Advanced degree required: PhD, MD, PharmD or non-US equivalent in a health science field
- 12+ years of relevant clinical development experience (pharmaceutical, biotech or CRO)
- Oncology clinical development experience required; early-stage development experience preferred
Benefits
- Competitive base salary (USD 230,000 - 260,000)
- Health, dental, and vision benefits
- 401(k) retirement plan
- Paid time off and holidays
- Professional development and conference support
- Equal employment opportunity employer
Average salary estimate
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