Oncology Early Stage Clinical Development Scientist; Director, Non MD

Role Summary

Oncology Early Stage Clinical Development Scientist (Director, Non MD) leads and coordinates the development of multiple early oncology studies (FIH, POM, ESOE, POC), collaborating with the Global Development Lead and cross-functional teams to establish and execute the early oncology clinical development plan. The role includes leading clinical protocol development and contributing as an individual on clinical teams to meet enrollment and study delivery timelines, ensuring representation of the Oncology Early Stage Development remit across study teams.

• 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, delivering 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 data quality, review emerging data and trends, query data, and present findings to teams and stakeholders.
• Conduct data review, analysis, and interpretation of trial data with GDL, Clinical Safety, and Biostatistics.
• Serve as a technical resource for clinical issues raised by internal/external collaborators, investigators, and contractors.
• Support development of publications, abstracts, and presentations.
• Contribute to project teams to support clinical development implementation and milestones, including start-up and delivery of ESOE and PoC trials.
• Lead preparation of clinical protocols and supporting documents (development plans, INDs, CSRs, IBs, SADs, regulatory documents).
• Foster transparent, collaborative partnerships across teams and therapeutic areas.
• Coordinate with Oncology Research Development and the broader WRD organization; build effective collaborations with internal/external partners.
• Work with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signals and patient stratification.
• Establish relationships with external experts, regulators, and investigator networks to inform plans, study designs, recruitment, and result presentation.
• Maintain up-to-date knowledge of scientific and clinical literature relevant to therapeutic areas and clinical development issues.
• Perform other duties related to clinical programs and contribute to departmental initiatives as requested.

• Required:
  
  PhD or Pharm
  
  D with a minimum of 5 years of experience in a similar role in industry/CRO, or
• Required:
  
  MS with a minimum of 7 years of experience in a similar role in industry/CRO, or
• Required:
  
  BA/BS with a minimum of 10 years of experience in a similar role in industry/CRO.
• Required:
  
  Clinical Research experience in Phase 1 in Oncology, on the sponsor side leading studies.
• Required:
  
  Experience or strong understanding of Oncology Drug Development, especially in Early Development.
• Required:
  
  Strong knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.
• Required:
  
  Strong scientific writing and communication skills (written and verbal).
• Required:
  
  Experience with clinical document writing (e.g., protocol, ICD, IB, IND) and understanding of complex data analysis.
• Required:
  
  Track record of scientific productivity (publications, posters, abstracts, presentations).
• Required:
  
  Experience working with related disciplines (Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA).
• Required:
  
  Experience building consensus and driving change across organizational levels, including senior management.
• Required:
  
  Data listing review experience.
• Required:
  
  Experience working in a fast-paced, team-based matrix environment and ability to work independently.
• Required:
  
  Experience performing complex data analyses using platforms such as JReview, Spot Fire, or SOCs-PRO.
• Preferred:
  Experience leading a team.

• PhD or Pharm
  
  D, or equivalent combination of education and experience as noted in qualifications.

• Physical/Mental Requirements:
  Perform complex data analysis.
• Travel: 5-10% travel.
• Work Arrangement:
  Hybrid role; live within commuting distance and work on-site approximately 2.5 days per week.