Oncology Early Stage Clinical Scientist (Director, Non-MD)

Role Summary

Oncology Early Stage Clinical Scientist (Director, Non-MD) will 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, ensuring the full scope of Oncology Early Stage Development is represented within clinical study teams.

Responsibilities

• Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
• Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Support execution for all FIH programs through proof-of concept
• Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
• Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Support and assist in the development of publications, abstracts, and presentations
• May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESOE and PoC trials
• Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of ESOE and POC trials)
• Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, CSRs, investigator brochures, SAPs, and regulatory documents
• Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas
• Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader WRD organization
• Develop effective collaborations with internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations
• Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification
• Establish and support relationships with external experts, regulators, key opinion leaders, and investigator networks to integrate the latest clinical thinking into development plans and study designs, and manage recruitment, analysis, interpretation, and presentation of results
• Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas
• Perform other duties as assigned related to clinical programs and support functional area priorities

Qualifications

• Required: PhD or PharmD with a minimum of 5 years in a similar role in industry/CRO, OR MS with a minimum of 7 years, OR BA/BS with a minimum of 10 years in a similar role in industry/CRO
• Clinical Research experience in Phase 1 in Oncology, on the sponsor side leading studies
• Experience or strong understanding of Oncology Drug Development, especially in Early Development
• Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA, EMA, and global regulations
• Strong scientific writing and communication skills (written and verbal)
• Experience in clinical document writing (protocol, ICD, IB, IND) and understanding of complex data analysis
• Track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience collaborating with Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance
• Experience building consensus and driving change across the organization, including senior management
• Data listing review experience
• Critical thinker; capable of working in fast-paced matrix environments and independently when appropriate
• Experience performing complex data analyses using tools such as JReview, SpotFire, SOCs-PRO or similar

Skills

• Leadership and cross-functional collaboration
• Scientific writing and data interpretation
• Strategic planning and project management
• Data analysis and regulatory documentation

Education

• PhD or PharmD or MS/BA with equivalent industry experience as stated above

Additional Requirements

• 5-10% Travel
• Hybrid work location: on-site ~2.5 days per week within commuting distance