Executive Director, Clinical Development (Remote)

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 earlystage 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 proofofconcept and latestage development.

The leader partners crossfunctionally with Discovery, Translational Medicine,
Regulatory, Biostatistics, Clinical Operations, Safety, and Commercial to ensure
highquality decisionmaking and timely progression of programs.

Essential Functions/Responsibilities
* Define the scientific and clinical development strategy for the early oncology portfolio across multiple modalities and tumor types.

Lead the design of firstinhuman (FIH), doseescalation, doseexpansion, and other earlyphase clinical trials to establish safety, PK/PD, and preliminary efficacy.
* Serve as the senior clinical voice for early oncology, influencing portfolio decisions, go/nogo criteria, and prioritization across programs.
* Drive integration of translational and biomarker strategies to enhance patient selection and accelerate proofofmechanism/proofofconcept.

Clinical Development & Execution
* Oversee medical monitoring and clinical deliverables for earlyphase 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.

CrossFunctional & External Collaboration
* Partner with Discovery and Translational teams to shape early pipeline strategy and mechanismofaction understanding.
* Collaborate closely with Clinical Operations, Biostatistics, and Regulatory Affairs to enable efficient study startup, 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 codevelopment collaborations.

People Leadership
* 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 decisionmaking.
* Foster a culture of scientific curiosity, accountability, collaboration, and operational excellence.

Required Knowledge, Skills, and Abilities
* MD or MD/PhD required; board certification in Oncology or Hematology/Oncology.
* 10+ years of industry experience in oncology drug development, including significant leadership in earlyphase clinical development.
* Proven success advancing oncology assets from IND through Phase 1-2, including firstinhuman studies.
* Experience interacting with global regulatory agencies on earlyphase clinical
programs.
* Deep understanding of tumor biology, translational science, PK/PD principles, and innovative clinical trial design.
* Demonstrated ability to lead clinical strategy for multiple programs simultaneously.
* Strong analytical skills and ability to interpret complex clinical and biomarker data.
* Exceptional communication skills and executive presence; capable of influencing across multiple organizational levels.
* Experience managing and developing highperforming clinical teams.

Required/Preferred Education and Licenses
* Medical degree, MD (MD/PhD preferred) with specialized training in Hematology, Oncology;
U.S. Board Certification/Eligibility preferred