Director, Clinical Science
Iovance Biotherapeutics, Inc.
August 18, 2026
Remote friendly (San Carlos, CA)
United States
$175,000 - $225,000 USD yearly
Clinical Research and Development
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%).
- 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%).