About the Role
We are seeking an experienced Programme Manager to lead and coordinate an accelerated development programme through CMC, preclinical, and IND-enabling phases. This is a unique opportunity to join a fast-moving biotech start-up in its build phase, driving execution across multiple CROs and workstreams.
The role is remote, requiring a highly flexible, hands-on approach and the ability to operate beyond rigid functional boundaries.
Key Responsibilities:
Programme Leadership:
- Maintain and drive the integrated development plan (CMC → PK → tox → IND).
- Own critical path, dependencies, risks, and mitigation strategies.
- Lead weekly operational cadence across internal teams and CROs.
- Adapt execution structure as the programme scales.
Vendor & CRO Management:
- Manage interactions with CROs across CMC, enzyme engineering, PK/PD, and in-vivo studies.
- Oversee SOWs, change orders, deliverables, budgets, and issue escalation.
- Ensure structured communication and alignment across all vendors.
CMC & Preclinical Coordination:
- Coordinate execution across analytics, linker/payload activities, formulation strategy, biodistribution, PK studies, and GLP tox planning.
Timeline, Budget & Documentation:
- Own Gantt charts, budget tracking, and deliverable logs.
- Ensure complete documentation and data-room organisation.
- Prepare operational materials for investors, advisors, and Board.
Regulatory Readiness:
- Coordinate packages and timelines supporting IND-enabling activities.
- Liaise with regulatory consultants to ensure programme alignment.
Build-Phase Flexibility:
- Operate effectively in a lean, high-intensity start-up environment.
- Contribute to establishing processes, templates, and operational cadence.
- Comfortable working outside narrow functional boundaries when needed.
Candidate Profile:
Essential Experience:
- 5+ years as a Programme/ Project Manager in biotech or CRO environments.
- Proven experience coordinating CMC and/or preclinical development programmes.
- Strong CRO/vendor management across multiple concurrent workstreams.
- Experience managing complex development timelines and budgets.
- Familiarity with biologics/ADC/large molecule workflows.
Desirable Experience:
- Exposure to ADCs or antibody-based therapeutics.
- Experience in early-stage or lean biotech settings.
- Contribution to IND-enabling packages.
Personal Attributes:
- Highly structured, delivery-focused, and operationally rigorous.
- Independent, proactive, and comfortable with ambiguity.
- Strong communicator with excellent organisational discipline.
- Thrives in a remote-first, high-accountability environment.
Ready to take ownership of a high-impact development programme and help bring first-in-class therapeutics to patients?
Apply now by sending your CV today!
