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Isomorphic Labs is an AI-driven drug discovery company applying frontier machine learning to accelerate scientific breakthroughs and develop life-changing medicines. The company was launched in 2021 to advance human health by building on the Nobel-winning AlphaFold system, combining drug discovery expertise with machine learning to model complex biological phenomena and design novel molecules.
The Senior Clinical Trial Manager will lead cross-functional teams through all phases of the clinical trial lifecycle, from start-up through conduct to close-out, ensuring compliance with ICH/GCP Guidelines and industry standards. This role carries both operational and potential managerial responsibilities, working closely with the Head of Clinical Operations as the department scales.
Key responsibilities include:
- Execute and manage all study start-up, maintenance, and close-out activities
- Lead cross-functional clinical study teams and mentor team members
- Manage vendor relationships, change orders, and cost oversight
- Drive development and maintenance of clinical trial documentation (Protocol, ICF, DSUR, IB, CSR) for timely submission readiness
- Oversee creation and updates of trial plans and training materials (SIV, amendment training, lab/pharmacy manuals)
- Support data management activities including review of study materials, edit checks, and Statistical Analysis Plan
- Participate in data cleaning and organize data snapshots for internal/external reviews
- Monitor vendor performance metrics, KPIs, and compliance
- Assess and implement AI solutions to streamline clinical operations and contract lifecycle management
- Coordinate and participate in all study-related meetings (investigator calls, safety reviews, DSMB)
- Support eTMF development and maintenance for audit readiness
- Ensure alignment with audit, SOP, and quality standards across trials
The role requires a strategic, analytical mindset with excellent problem-solving skills in fast-paced, matrixed environments. Strong cross-functional relationship-building and vendor management experience are essential. The position requires up to 30% travel.
Requirements:
Essential:
- Bachelor's Degree in a related field
- Minimum 6 years experience in biotech and/or pharmaceutical industries
- At least 3+ years managing oncology or rare disease trials
- Thorough understanding of GCP/ICH Guidelines and cross-functional clinical processes
- Excellent interpersonal and communication skills (verbal and written)
- Proactive problem-solving, planning, and project management skills
- Strong outsourced model experience with vendor budget management
- Ability and willingness to travel up to 30%
Nice to have:
- Prior CRA experience and/or willingness to co-monitor
- Prior site experience (coordinator or other clinical site roles)
