Associate Director, Clinical Science
$165,000–$231,000 year
HybridIrvine, California, United States
Job Summary
Lead clinical strategy development for assigned programs by authoring trial protocols, synthesizing cross-functional data, and managing site/CRO inquiries regarding protocol execution and patient-specific questions. Review and finalize clinical documents including Investigator Brochures, Clinical Study Reports, and statistical analysis plans while partnering with data management to resolve clinical queries. Contribute to the Clinical Development Plan, conduct medical data reviews, and identify safety events across studies. Present clinical findings at internal meetings and external forums, collaborate on regulatory submissions, and provide input on SOP revisions. Requires advanced clinical degree, 10+ years of experience, and 50% travel. Based in Irvine with hybrid work options.
Required Qualifications
- 10+ years minimum experience
- 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist)
- 5+ years of experience with clinical trials
- Experience authoring clinical trial protocols and/or study results and conclusions
- In-depth understanding of drug development
- Working knowledge of basic biostatistics
- Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance
- Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonization, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations
- Has demonstrated, through past experience, abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies
- Strong presentation skills: effective at summarizing and presenting the key considerations and decision points
- Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.
- Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results
- Able to work in a fast-paced dynamic organization
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed
- Some travel may be required – up to 50%
- Advanced clinical/science degree preferred (PharmD, PhD, OD, MD)
Desired Qualifications
- Eye care experience preferred
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