Director, Clinical Science

Overview / Role

Director, Clinical Science develops Clinical Development Plans (CDPs) and supports assigned Medical Directors/Clinical Science Physicians and the Head of Clinical Science with deliverables for assigned assets/indications.

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.

Qualifications / Skills

• - 7+ years oncology clinical trial experience; 5+ years clinical science/clinical development.
• - Data listing review experience (mandatory).
• - Advanced degree preferred (PhD/PharmD/MD).
• - Cell therapy clinical development experience preferred.
• - Experience authoring experimental protocols and/or study results/conclusions.
• - In-depth Phase 1–4 drug development knowledge.
• - Strong analytical skills; data analysis/interpretation and clinical relevance experience.
• - Comprehensive product/safety profile knowledge; GCP/ICH and regulatory guideline knowledge (FDA/EMEA/NICE).
• - Strong Microsoft Office skills (Word, PowerPoint, Excel).
• - Excellent project management; communication and influencing skills; strong written/presentation skills.
• - Ability to travel (~25%).