Executive Director, Clinical Development (Remote)

Role Summary

The Executive Medical Director, Oncology Clinical Development, and Head of Early Oncology Programs is a senior R&D leader responsible for driving the strategy, design, and execution of early‑stage oncology clinical programs (Phase 0–2). This role oversees a portfolio of innovative therapeutic candidates and plays a critical role in shaping the early development pipeline, integrating translational science, biomarker strategy, and clinical execution to advance assets efficiently to proof‑of‑concept and late‑stage development. The leader partners cross‑functionally with Discovery, Translational Medicine, Regulatory, Biostatistics, Clinical Operations, Safety, and Commercial to ensure high‑quality decision‑making and timely progression of programs.

Responsibilities

• Define the scientific and clinical development strategy for the early oncology portfolio across multiple modalities and tumor types.
• Lead the design of first‑in‑human (FIH), dose‑escalation, dose‑expansion, and other early‑phase clinical trials to establish safety, PK/PD, and preliminary efficacy.
• Serve as the senior clinical voice for early oncology, influencing portfolio decisions, go/no‑go criteria, and prioritization across programs.
• Drive integration of translational and biomarker strategies to enhance patient selection and accelerate proof‑of‑mechanism/proof‑of‑concept.
• Oversee medical monitoring and clinical deliverables for early‑phase oncology studies.
• Provide expert clinical input into protocol development, IND submissions, regulatory interactions, and clinical study reports.
• Ensure early clinical programs meet the highest standards of scientific rigor, patient safety, and compliance with global regulations.
• Review and interpret emerging clinical and translational data, informing dose selection, cohort expansion, and program advancement.
• Partner with Discovery and Translational teams to shape early pipeline strategy and mechanism‑of‑action understanding.
• Collaborate closely with Clinical Operations, Biostatistics, and Regulatory Affairs to enable efficient study start‑up, enrollment, and execution.
• Represent the company in external interactions, including KOL engagements, academic collaborations, scientific advisory boards, and regulatory meetings (FDA, EMA, etc.).
• Provide clinical leadership for alliance partners and co‑development collaborations.
• Lead and mentor a team of medical directors, clinicians, and clinical scientists working across early oncology programs.
• Develop organizational capability in early development strategy, medical excellence, and decision‑making.
• Foster a culture of scientific curiosity, accountability, collaboration, and operational excellence.

Qualifications

• Required: MD or MD/PhD; board certification in Oncology or Hematology/Oncology.
• Required: 10+ years of industry experience in oncology drug development, including significant leadership in early‑phase clinical development.
• Required: Proven success advancing oncology assets from IND through Phase 1–2, including first‑in‑human studies.
• Required: Experience interacting with global regulatory agencies on early‑phase clinical programs.
• Required: Deep understanding of tumor biology, translational science, PK/PD principles, and innovative clinical trial design.
• Required: Demonstrated ability to lead clinical strategy for multiple programs simultaneously.
• Required: Strong analytical skills and ability to interpret complex clinical and biomarker data.
• Required: Exceptional communication skills and executive presence; capable of influencing across multiple organizational levels.
• Required: Experience managing and developing high‑performing clinical teams.
• Preferred: U.S. Board Certification/Eligibility.

Education

• Medical degree, MD (MD/PhD preferred) with specialized training in Hematology/Oncology.

Skills

• Strategic leadership and people development across medical directors, clinicians, and clinical scientists.
• Cross‑functional collaboration across Discovery, Translational Medicine, Regulatory, Biostatistics, Clinical Operations, and Safety.
• External engagement with KOLs, academic collaborations, scientific advisory boards, and regulatory authorities.
• Effective communication of complex scientific data to diverse stakeholders and executive leadership.