My client is looking to bring on a CMO to the team. A hands-on, high-trust role at a defining stage for the company. The CMO will own clinical and regulatory strategy across the pipeline, lead FDA engagement, shape orphan-drug and breakthrough-designation strategy from emerging data, and help establish the company's foothold in the US. The CEO is seeking a committed partner who wants to build — not a passive advisory appointment.
Key Responsibilities
Own clinical development strategy across hematology/oncology and rare liver-cancer programs
Lead FDA interactions and act as the company's primary agency-facing clinical voice
Drive orphan drug and breakthrough therapy designation strategy against emerging data, reducing reliance on external consultants
Advance programs from preclinical into first-in-human and through early clinical development
Support pipeline expansion into further indications
Help establish the company's US clinical and regulatory presence
Partner closely with the CEO and CSO on development and corporate strategy
Job Requirements
Substantial FDA experience, with a genuine understanding of how the Agency thinks and a record of direct regulatory interactions
Oncology clinical development experience, ideally hematology-oncology
Orphan / rare-disease drug development experience, including orphan drug and/or breakthrough therapy designations
Track record advancing assets from preclinical into first-in-human, including IND experience
US-based (Boston, Houston or San Francisco; East Coast advantageous for European overlap)
A committed, hands-on operator with the drive to build — someone who will treat this as more than another fractional role
Responsive, high-trust communicator with strong personal fit alongside a founder-led team
Required Board certification in Hematology
Required experience in rare cancers
Required experience helping a European biotech establish a US footprint
2 days/week to start (through year-end) then scaling to 60% the following year
12 month contract
Target start date is October 1st