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 early oncology clinical development plans, develop clinical protocols, and participate as an individual contributor on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

• Partner 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 trial designs, high-quality trial execution, safety assessment, and interpretation of results.
• Support execution for all FIH programs through proof-of-concept.
• Set the clinical data review strategy, ensure data quality, review and discuss emerging data and trends, and present data to teams and stakeholders.
• Conduct data review, analysis, and interpretation of trial data with GDL, Clinical Safety, and Biostatistics.
• Serve as technical resource for clinical issues raised by internal/external collaborators, investigators, and contractors.
• Support development of publications, abstracts, and presentations.
• Participate in project teams to support clinical development implementation and milestones (start-up and delivery of ESOE and POC trials).
• Lead preparation of clinical protocols and supporting documents (CDPs, INDs, CSRs, IBs, SAPs, regulatory documents).
• Foster transparent partnerships across teams and therapeutic areas.
• Coordinate with ORD and WRD; develop collaborations with internal/external partners across relevant functions.
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy and patient stratification.
• Establish relationships with external experts, regulators, and investigator networks; manage study recruitment, analysis, interpretation, and presentation of results.
• Maintain up-to-date knowledge of literature and clinical development issues.
• Perform other duties related to clinical programs and support departmental initiatives as requested.

Qualifications

• Relevant PhD or PharmD with 5+ years in a similar role in industry/CRO; OR
• MS with 7+ years in a similar role; OR
• BA/BS with 10+ years in a similar role.
• Clinical Research experience in Phase 1 Oncology, sponsor-led.
• Understanding of Oncology Drug Development, especially Early Development.
• Strong knowledge of clinical procedures, ICH/GCP, and familiarity with FDA/EMA/global regulations.
• Scientific writing and communication skills; experience with protocol/IB/IND writing and data analysis.
• Track record of publications, posters, abstracts, or presentations.
• Experience in related disciplines (Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, etc.).
• Ability to build consensus and drive change; 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 platforms.

Skills

• Leadership and collaboration across cross-functional teams
• Clinical study design, data interpretation, and regulatory documentation
• Strong scientific writing and communication

Education

• PhD/PharmD or equivalent advanced degree (required for senior level)

Additional Requirements

• 5-10% travel
• Hybrid work location