Senior Director, Clinical Science, Oncology Early Development (Hybrid)

Role Overview

The Senior Director, Clinical Science, Oncology Early Development provides strategic Clinical Science leadership for novel assets from candidate transition through first-in-human development and clinical proof-of-concept. Reporting to the Executive Director, this role applies deep expertise in early-phase oncology, translational medicine, biomarker strategy, and first-in-human trial design to shape development plans, strengthen scientific rigor, and enable data-driven decision-making across the early oncology portfolio.

Key Responsibilities

• Provide strategic Clinical Science leadership across Oncology Early Development, including multiple studies, programs, and assets.
• Contribute to early clinical development strategy from candidate transition through first-in-human evaluation and clinical proof-of-concept.
• Integrate disease biology, mechanism of action, translational evidence, competitive landscape, and emerging data to identify development opportunities, risks, and key decision points.
• Establish and advance consistent Clinical Science standards for early development planning, medical data review, dose-escalation meetings, data interpretation, and key deliverables.
• Guide interpretation of clinical data across studies, cohorts, and assets to support understanding of trends, opportunities, risks, and program implications.
• Contribute scientific perspective to protocol development, amendments, study design, endpoint selection, eligibility criteria, and biomarker strategy discussions.
• Contribute Clinical Science expertise to portfolio discussions, governance reviews, and senior leadership meetings.
• Provide direct management for Directors, Principal Scientists, and Clinical Scientists, setting clear expectations and supporting talent development through coaching and mentoring.
• Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, and Medical Affairs.
• Ensure Clinical Science activities comply with regulatory requirements, company policies, and established procedures; support inspection readiness.

Education

• Advanced scientific or healthcare degree required (e.g., PhD, PharmD), or equivalent, with 8+ years of pharmaceutical, clinical drug development, and/or medical field experience preferred.
• Master’s degree, preferably in life sciences, with 12+ years of pharmaceutical, clinical drug development, and/or medical field experience.
• Bachelor’s degree, preferably in life sciences, with 15+ years of pharmaceutical, clinical drug development, and/or medical field experience.

Experience

• Significant experience in Clinical Development, Clinical Science, clinical drug development, or a related function within the pharmaceutical or biotechnology industry, with substantial responsibility in early-phase development.
• Demonstrated leadership of first-in-human and early-phase oncology studies, including dose escalation, dose optimization, cohort expansion, and proof-of-concept planning.
• Deep understanding of oncology disease biology, novel mechanisms and modalities, translational medicine, biomarker-driven development, PK/PD, and safety and tolerability assessment.
• Strong understanding of clinical trial design, clinical development strategy, clinical data review, and interpretation of oncology data.
• Experience contributing to protocols, regulatory submissions, safety reviews, health authority interactions, governance discussions, and cross-program planning.
• Experience working effectively within cross-functional teams in a matrixed environment.
• Demonstrated ability to integrate information across studies and programs to support scientific and business decision-making.
• Excellent communication, influence, and executive presentation skills.
• Demonstrated people leadership experience, including management, coaching, and development of scientific staff.

Travel

0-15% travel.