• Remote within the United States
• Travel as needed (KOL engagements, FDA meetings, scientific conferences)
• MD required with 15+ years clinical development experience
• Proven leadership in Phase III oncology trials and regulatory approval

Newave Pharmaceutical Inc (Newave) is looking to hire a full-time Chief Medical Officer (CMO) in the United States (remote). Newave is a clinical-stage biotechnology company headquartered in Pleasanton, CA, focused on developing innovative small molecule therapies in oncology, infectious diseases, and autoimmune disorders.
We are at a critical inflection point, with a global Phase III pivotal trial underway and first patient enrollment imminent , alongside ongoing Phase I programs.

Description
SCHEDULE: Full-time

Work Location:
This is a Work from Home position, and candidates can be located anywhere in the United States.

Summary of Position:
The Chief Medical Officer will serve as a key member of the executive leadership team and will be responsible for the strategy and execution of Newave's oncology clinical programs, especially for global Phase III program . The role will lead the global Phase III program from first patient in (FPI) through execution, regulatory milestones, and submission toward approval , while also guiding early-stage pipeline strategy.

Duties
Provide executive leadership for the global Phase III pivotal program
Ensure successful execution from first patient in (FPI) through study completion and regulatory submission
Oversee CRO-led operations, ensuring quality, timelines, and enrollment targets are achieved
Drive cross-functional alignment and proactive issue resolution across regions
Establish sponsor oversight frameworks including performance management and risk mitigation
Lead all interactions with the FDA and drive regulatory strategy toward NDA/BLA submission
Guide expedited pathways such as Fast Track and Breakthrough Therapy designation where applicable
Lead and optimize an established U.S. clinical organization
Direct Phase I strategy including dose expansion, indication prioritization, and patient population selection
Partner with global teams to ensure alignment across U.S. and ex-U.S. programs
Build and maintain relationships with oncology KOLs and investigators
Support business development

Qualifications
You should have:
MD (or equivalent) with board certification in Oncology or Hematology, especially in Hematology
15+ years of industry experience in clinical development
Proven track record leading Phase III trials through regulatory milestones and approval
Deep expertise in hematologic malignancies
Extensive FDA interaction experience (Type B/C, Pre-NDA)
Demonstrated leadership of clinical teams, CROs, and global programs

It would be helpful if you had:
Prior CMO or senior clinical leadership experience
Experience in global or multi-region clinical development
Established oncology KOL network

We would love to talk to you about this opportunity. If you are highly qualified, you will hear from one of our recruiters. We are actively interviewing so apply today.
We are an equal opportunity employer and value diversity at our company.