Project Manager Drug Development (Part-Time)

About the Opportunity

LabGenius is seeking an experienced Drug Development Project Manager (Part-Time, 3 days a week) to support the progression of their lead therapeutic asset from preclinical development through to a successful IND submission and into Phase 1 Clinical trials.

Responsibilities

• Work with the Project Team Lead to develop and maintain the integrated project plan covering preclinical, CMC, regulatory and early clinical readiness.
• Provide oversight of the project budget including the CMC budget in collaboration with the Project Lead, providing regular reporting to the VP of Finance.
• Timeline tracking - use project management tools to maintain a live Critical path and identify potential delays before they impact the IND filing date.
• Act as the primary interface for the CDMO performing Drug Substance and Drug Product process development, tech transfer and GMP manufacturing, ensuring that all activities are delivered on time and within budget, proactively managing Change Orders, and ensuring rigorous maintenance of key documentation.
• In close collaboration with the PTL and Regulatory experts, coordinate the cross functional effort to prepare and compile regulatory submissions for the First in Human trial.
• Maintain and update the program risk register, identifying scientific, regulatory and manufacturing risk early to implement proactive contingency plans.

About You

What we’re looking for:

• Proven experience in project managing multiple antibody-based oncology drug discovery programmes across interdisciplinary functions and teams.
• Bachelors degree in Life Sciences, Bioengineering, or a related field required; advanced degrees (MSc/PhD) strongly preferred.
• Deep understanding of the drug development lifecycle, including GLP/GMP/GCP requirements, CMC development, and nonclinical study design.
• Proven track record of successfully managing external CDMOs and CROs in a fast-paced environment.
• Expert user of project management software such as Microsoft Project or Smartsheet.

Eligibility

Nice to have:

• Previous experience of working effectively within a startup organisation.
• PMP certification is advantageous.

Benefits

Aside from being part of LabGenius's purpose-driven team, you’ll also enjoy:

• Financial:
  • Discretionary performance-linked annual bonus
  • A generous stock option plan
  • 5% pension, with an additional top up on tax savings
• Health:
  • Private Medical Insurance, including dental and optical
  • Discounted gym membership
  • Employee Assistance Programme including access to coaching and CBT sessions
• Time-Off:
  • 25 days annual leave (plus the bank holidays)
  • Enhanced sick leave and Income Protection
  • 1 day paid for moving home
• Team-building:
  • Weekly team lunches
  • A programme of social events

About Company

LabGenius is an equal opportunity employer that believes in diversity and inclusion. They encourage all candidates to apply regardless of meeting every single requirement of the role.