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Bicara Therapeutics, a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation, is seeking a Senior Clinical Trial Manager to oversee multiple regions and lead operational execution of clinical trials. You will own day-to-day management of one or more clinical trials, partnering with cross-functional teams, clinical sites, and CRO partners to ensure studies are executed to the highest standards of quality and compliance.
Key responsibilities include executing Bicara's clinical operations strategy focused on adaptive, patient-centered trial designs; supporting the clinical operations team to ensure all trial deliverables meet timelines, budgets, and quality standards; developing study documents and tools; managing relationships with external collaboration partners; proactively identifying and managing clinical study challenges and risks; overseeing site identification, enrollment models, clinical supply planning, and budget planning; monitoring CRO and third-party vendor compliance with regulations; developing and revising scope of service agreements and budgets with CROs; participating in protocol development and informed consent documentation; overseeing Case Report Form design and data monitoring; managing study management teams to facilitate clinical development goals; executing CRO oversight activities including monitoring visit reviews and sponsor oversight visits; contributing to regulatory documents including Investigators' Brochures and safety updates; and potentially managing a team of Clinical Trial Associates including hiring and professional development.
You will work alongside a mission-driven team that values collaboration, respect, and urgency. The role requires navigating global regulatory requirements, cultural nuances, and varying site capabilities across multiple geographies while maintaining strong vendor oversight and risk management.
QUALIFICATIONS:
- Bachelor's Degree required, preferably in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum 5 years' clinical trial management experience in pharmaceutical, biotech, and/or CRO industry
- Demonstrated ability to manage global clinical trials, navigating regional regulatory requirements and multiple geographies
- Phase 2/Phase 3 study experience strongly preferred
- Oncology study experience strongly preferred
- Clinical research operational knowledge, computer literacy, and strong project planning/management including CRO/vendor oversight
- Global clinical trial management in fast-paced CRO outsourced environment required
- Experience managing global or regional teams in virtual environment
- Strong decision-making, communication, and collaboration skills
- Analytic skills and effectiveness in problem-solving
- Adaptability and comfort working in fast-paced environment
- Effective leadership skills and proven ability to foster team productivity and quality deliverables
