cmc development

6 days ago

London, Greater London, United Kingdom Discover International Full time

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

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