Director, Oncology Early-Stage Clinical Scientist

Role Summary

Director, Oncology Early-Stage Clinical Scientist. Lead and coordinate the development of multiple studies of novel biological and small molecules for FIH, POM, ESOE, and POC studies in Oncology. Collaborate with the Global Development Lead and development team to establish and execute the early oncology clinical development plans, develop clinical protocols, and contribute as an individual on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

• Partner closely with the Global Development Lead in executing the clinical development strategy and plan for assigned molecules/indications
• Provide scientific leadership and execution of clinical studies, innovative study designs, trial execution, safety assessment, and interpretation of results
• Support execution for all FIH programs through POC
• Set the clinical data review strategy, ensure data quality, review emerging data and trends, and present findings to teams and stakeholders
• Conduct data review, analysis, and interpretation with GDL, Clinical Safety, and Biostatistics
• Serve as a technical resource for clinical issues raised by internal and external collaborators
• Support development of publications, abstracts, and presentations
• May sit on project teams to support development implementation and milestones (ESoE and PoC trials)
• Lead preparation of clinical protocols and critical documents (CDPs, INDs, CSRs, IBs, SAPs, regulatory documents)
• Foster transparent partnerships across teams and therapeutic areas
• Coordinate with ORD and WRD organizations; develop collaborations with internal and external partners
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signs and patient stratification
• Establish relationships with external experts, regulators, and investigator networks; manage recruitment, analysis, and presentation of results
• Maintain knowledge of scientific and clinical literature relevant to therapeutic areas
• Perform other duties related to clinical programs and support departmental initiatives as requested

Qualifications

• Required: PhD or PharmD with 5+ years in a similar role in industry/CRO; or MS with 7+ years; or BA/BS with 10+ years
• Clinical Research experience in Phase 1 Oncology, sponsor-led
• Strong understanding of Oncology Drug Development, especially Early Development
• Knowledge of clinical procedures, ICH, GCP; familiarity with FDA/EMA/global regulations
• Strong scientific writing and communication skills; experience with protocol, ICD, IB, IND writing; data analysis
• Track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience with related disciplines (Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA)
• Ability to build consensus and drive change across organization levels
• Data listing review experience
• Critical thinker; able to work in fast-paced matrix environment and independently
• Experience with data analysis tools (e.g., JReview, SpotFire, SOCs-PRO or similar)

Skills

• Scientific leadership and collaboration
• Clinical data interpretation and strategic thinking
• Regulatory writing and documentation
• Stakeholder management and cross-functional partnership
• Biomarker integration and translational development

Education

• PhD or PharmD required; alternative with MS or BA/BS with equivalent years of experience as noted under Qualifications

Additional Requirements

• Travel: 5-10%
• Work Location: Hybrid
• Physical/Mental Requirements: Perform complex data analysis