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About the Role
The Director of Clinical Science will support clinical programs with an emphasis on data review, analysis, and interpretation to ensure study quality, accuracy, and integrity. This role requires hands-on clinical science experience, familiarity with data management, and a background in leading natural history studies. The individual will dive deep into complex datasets to uncover insights that drive program success.
Responsibilities
- Provide scientific leadership for clinical programs including study, data interpretation, and reporting.
- Lead and participate in clinical data review and analysis to support data cleaning, patient safety review, and data integrity throughout the study lifecycle.
- Partner with clinical development, clinical operations, and data management to ensure high-quality data delivery.
- Contribute to data interpretation that informs clinical trial results, regulatory submissions, and publications.
- Support preparation of manuscripts, abstracts, posters, and presentations by assembling data outputs and ensuring scientific accuracy.
- Provide scientific and clinical input into study design, endpoint selection, and statistical analysis planning.
- Participate in cross-functional team meetings and act as a clinical science point of contact for internal and external stakeholders.
- Contribute to the development and review of key study documents (e.g., protocols, CRFs, data review plans, study reports, regulatory submissions).
- Support data management activities including database design input, eCRF development, and oversight of data flow.
Requirements
- 7+ years of experience in clinical science and/or epidemiology within the biotech or pharmaceutical industry.
- Demonstrated expertise in data review, analysis, and interpretation.
- Strong understanding of clinical trial methodology, Good Clinical Practice (GCP), and regulatory requirements.
- Familiarity with data management concepts, tools, and processes (e.g., EDC, eCRF design, query management), specifically in Medidata RAVE.
- Experience with natural history studies, epidemiology studies, and real-world evidence (RWE), in oncology and/or rare diseases.
- Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Strong written and verbal communication skills, with proven ability to collaborate across functions.
Skills
- Clinical Science
- Data Management
- Natural History Studies
- Data Review
- Data Analysis
- Data Interpretation
- Clinical Trial Methodology
- Good Clinical Practice (GCP)
- Regulatory Requirements
- Medidata RAVE
- Epidemiology Studies
- Real-World Evidence (RWE)
- Oncology
- Rare Diseases
- Organizational Skills
- Communication Skills
- Collaboration
Location
- South San Francisco, California
Work Type
- Full-time
Experience Level
- 7+ years
Education Level
- Advanced degree in life sciences (PhD, PharmD, M.S., or equivalent preferred)
About the Company
- Electra Therapeutics is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.