Director, Clinical Science - Oncology Development Lead

Scorpion Therapeutics; San Carlos (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in San Carlos, CA, seeks a Director, Clinical Science to drive Clinical Development Plans and support CDS deliverables for assets under development.

The role leads CSCT/CST activities, interfaces with Biomarkers, Biostatistics, Regulatory, and Operations, and helps shape CS strategy and lifecycle plans. Advanced degree preferred; 7+ years oncology trial experience; travel ~25%.

Qualifications

• 7+ years of oncology clinical trial experience.
• 5+ years in clinical science or clinical development.
• Data listing review experience mandatory.
• Advanced degree preferred (PhD/PharmD/MD).
• Cell therapy clinical development experience preferred.
• Strong GCP/ICH and regulatory knowledge.
• Excellent written and verbal communication.
• Ability to travel ~25%.

Responsibilities

• Participate in Clinical Development Core Team (CSCT) and Clinical Sub-Team (CST) meetings; interface with Biomarkers, Biometrics, Business Development, Clinical Operations, Legal, Logistics/Manufacturing Ops, PK/PD, Process Development, Project Management, Quality Assurance, Regulatory Affairs, Translational Medicine, and other groups.
• Represent Clinical Science in operational meetings (e.g., SMT).
• Support training for new CSCT members.
• Maintain up-to-date therapeutic/disease area scientific and clinical knowledge; collaborate with internal/external stakeholders (investigators, clinicians, scientists, KOLs).
• Support clinical science inputs to CS strategy and Lifecycle Plans (LCPs); contribute to CTP development; gather/analyze data to create the CS plan.
• Provide clinical science support for studies/programs: literature searches; input on study designs; design protocols/manuals/forms.
• Collaborate on consistent ICF, eligibility, dose modification, safety, CRFs, and CRF instructions; coordinate document completion.
• Write/review clinical science documents (protocol summaries, safety monitoring plans, investigator brochures, etc.); support safety narrative reviews.
• Develop/provide input for presentations and study communications; support site training.
• Review and discuss clinical reporting documents; track and support protocol/ICF amendments.
• Support internal/external meetings and communications strategies; coordinate scientific meeting submissions; write/review abstracts/posters/content.
• Support completion/submission of regulatory filings and required clinical documentation; lead/complete special projects as assigned.

Skills

Data analysis

Scientific communication

Project management

Cross-functional collaboration

Medical writing

Regulatory knowledge

Education

PhD/PharmD/MD

Tools

Microsoft Office

Job description

Scorpion Therapeutics in San Carlos, CA, seeks a Director, Clinical Science to drive Clinical Development Plans and support CDS deliverables for assets under development.

The role leads CSCT/CST activities, interfaces with Biomarkers, Biostatistics, Regulatory, and Operations, and helps shape CS strategy and lifecycle plans. Advanced degree preferred; 7+ years oncology trial experience; travel ~25%.