A fractional CMO opportunity focused on hematology and rare cancers, owning clinical and regulatory strategy, leading FDA engagements, and helping a European biotech establish its US presence.
The client is seeking a hands-on CMO to take ownership of clinical and regulatory strategy across a hematology/oncology and rare liver-cancer pipeline. The role requires direct FDA engagement, shaping orphan drug and breakthrough therapy designation strategies based on emerging data, and advancing programs from preclinical through early clinical development. This is a committed, high-trust position within a founder-led team, not a passive advisory appointment.
The engagement begins at two days per week through year-end, scaling to approximately 60% in the following year, with a 12-month contract and a target start date of 1 October. US-based candidates in Boston, Houston, or San Francisco are preferred, with East Coast location advantageous for European time-zone overlap.
- Own clinical development strategy across hematology/oncology and rare liver-cancer programmes
- Lead FDA interactions and serve as the company's primary agency-facing clinical voice
- Drive orphan drug and breakthrough therapy designation strategy, reducing reliance on external consultants
- Advance assets from preclinical into first-in-human and through early clinical development phases
- Support pipeline expansion into additional indications as opportunities arise
- Partner closely with the CEO and CSO on development planning and corporate strategy
- Substantial FDA experience with a demonstrated record of direct regulatory interactions
- Oncology clinical development background, ideally within hematology-oncology
- Orphan and rare-disease drug development experience, including designation track record
- IND experience and a history of advancing assets from preclinical into first-in-human trials
- Board certification in Hematology and prior experience in rare cancers
- Prior experience supporting a European biotech in establishing a US clinical and regulatory footprint
Barrington James is a specialist life sciences recruitment consultancy operating across clinical, regulatory, and commercial functions. The firm connects emerging and established biotech and pharma organisations with senior talent, including fractional and interim leadership appointments across global markets.
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