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 first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. Collaborate with the Global Development Lead and development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). Lead the development of the clinical protocol and participate as an individual contributor on clinical teams to meet enrollment and study delivery timelines. Ensure full scope of Oncology Early Stage Development is represented within clinical study teams.

Responsibilities

• Partner closely with the Global Development Lead in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
• Lead scientific leadership and execution of clinical studies, innovative study 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 quality data, review emerging data and trends; present data to teams and stakeholders
• Conduct data review, analysis, and interpretation of clinical trial data with the GDL, Clinical Safety, and Biostatistics
• Serve as a technical resource for clinical issues raised by collaborators, investigators, consultants, and contractors
• Support development of publications, abstracts, and presentations
• May participate in project teams to support clinical development and milestones, including start-up and delivery of ESoE and PoC trials
• Lead the preparation of clinical protocols and critical documents (e.g., clinical development plans, INDs, CSRs, IBs, ICH/SDs, regulatory documents)
• Foster transparent partnerships and collaboration across teams and therapeutic areas
• Coordinate with ORD/WRD and 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 investigators; manage recruitment, analysis, and presentation of results
• Maintain up-to-date knowledge of scientific and clinical literature in relevant areas
• Perform other duties related to clinical programs and support departmental initiatives

Qualifications

• Relevant PhD or PharmD with a minimum of 5 years of experience in a similar role in industry/CRO, OR
• MS with a minimum of 7 years of experience in a similar role in industry/CRO, OR
• BA/BS with a minimum of 10 years of experience in a similar role in industry/CRO
• Clinical Research experience in Phase 1 Oncology, sponsor-led
• Strong understanding of Oncology Drug Development, especially in Early Development
• Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA/global regulations
• Strong scientific writing and communication skills; experience writing protocols, ICDs, IBs, INDs; 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)
• Experience building consensus and driving change; data listing review experience
• Critical thinker with ability to work in fast-paced, matrix environment or independently
• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or similar tools

Education

• Preferred: Experience leading a team

Additional Requirements

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