Senior Director, Clinical Indication Lead (Oncology)

Key Responsibilities

Clinical Strategy & Asset Leadership

• Owns and drives clinical development strategy across given asset indications, aligned to overall asset strategy, Target Product Profile (TPP), and relevant disease area strategy.
• May lead the Clinical Development Team(s) for given indication(s) depending on program structure
• Provides clinical and disease area expertise to integrated disease area and portfolio and therapeutic level strategies
• Represents Clinical as the internal and external authority for the indication/disease area, including regulatory interactions and Business Development support.
• Engages cross-functionally with internal leaders and partners with external investigators, key opinion leaders, and patient advocacy groups.
• Presents clinical strategy, data, and risk assessments to governance bodies, health authorities, and senior leadership.

Clinical Study Design, Execution & Oversight

• Leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for given asset indication(s)
• Ensures studies meet regulatory, quality, medical, and access objectives and are aligned with target label indications.
• Ensures high quality, timely delivery of innovative protocols and data packages for CSRs and Regulatory Filings; implements quality assurance plans
• Accountable for clinical content and data quality for CSRs, trial documents, regulatory submissions, briefing books, and publications.
• Oversees trial progress, proactively identifies and mitigates risk, and provides regular status and risk updates to senior management.
• Champions quality, compliance, and GCP adherence across all clinical activities, partnering with Development Operations and Compliance as needed.

Team Leadership & Talent Development

• Sets priorities aligned to program objectives and works with Clinical Asset leadership to ensure appropriate budget/resourcing
• Attracts, develops, and retains top clinical talent through effective leadership, mentoring, and training.
• Fosters a culture of scientific excellence, collaboration, innovation, and accountability.

Qualifications & Experience

• Advanced degree in Life Sciences required (PhD, PharmD, MS, RN, MD or related field, MD)
• Deep clinical and therapeutic area expertise with advanced knowledge of drug development, competitive landscape, and health authority expectations.
• 8+ years of relevant experience, including leadership in the design and execution of multiple clinical trials.
• Demonstrated success in people leadership and/or matrix leadership roles.