Contract Length: 12 months
Workload: 20 hours/week
Location: UK-based role
Start Date: November
Engagement: B2B
Role Overview:
We are seeking an experienced CMC leader to drive Chemistry, Manufacturing & Controls (CMC) activities for the late-stage clinical development of a novel Fc-fusion protein targeting NT-3 for chronic pain and osteoarthritis. This role will focus on ensuring readiness for large, global Phase III studies while managing end-of-Phase II CMC deliverables and regulatory expectations.
Key Responsibilities:
* Lead CMC activities for late-stage clinical development of the asset.
* Drive IND preparation and deliver end-of-Phase II CMC packages to support asset readiness for pivotal trials across multiple regions.
* Oversee fit-for-purpose CMC transition from Phase II to pivotal trials, closing data gaps and remediating deficiencies in technical packages.
* Collaborate closely with internal stakeholders and external CDMOs on process technology transfer, scale-up, DS/DP manufacturing, and late-phase CMC strategy.
* Advise the executive team on CMC risks, mitigation strategies, and regulatory interactions in the context of strategic partnerships and fundraising discussions.
Required Experience:
* Significant experience with late-stage CMC for biological fusion proteins.
* Proven track record in managing CMC for late-phase clinical trials (Phase II to Phase III).
* Strong knowledge of process technology transfer, scale-up, and DS/DP manufacturing.
* Experience in regulatory interactions and preparing IND/CMC submissions.
Preferred Qualifications:
* Strong communication skills to advise executive leadership.
* Ability to manage external CDMOs and cross-functional teams effectively.
* Experience in strategic partnering/fundraising scenarios is advantageous.
Additional Details:
* Availability: November
* Capacity: Up to 20 hours/week