Jobs at Bicara Therapeutics

Own and continuously improve risk-based GxP audit programs covering clinical sites, vendors, and internal processes. Lead audit planning, execution, reporting, response resolution, CAPA completion, inspection readiness, auditor management, compliance trending, metrics, and audit-record maintenance. Apply global GMP/GCP regulations, manage stakeholders and contract auditors, and refine quality processes, tools, and templates.

Leads biostatistical strategy and serves as lead statistician for oncology clinical programs. Designs and analyzes trials, contributes to protocols and statistical analysis plans, oversees analyses and reporting, manages CRO and vendor deliverables, supports regulatory submissions and scientific publications, and promotes statistical understanding across cross-functional teams.

Serve as FP&A business partner to Development functions (Clinical, CMC, Supply Chain, Regulatory). Lead budgeting, long-range planning, trial forecasting, cost-of-goods analysis, KPI development, financial consolidation in Adaptive Planning, and scenario modeling to support pipeline, launch, and lifecycle decisions.

The Senior Director of Regulatory Affairs will lead and execute US regulatory strategy for biologics, manage a team, and ensure compliance with global regulations while interacting with health authorities.

Leads and scales marketing operations for biotech pre-launch and launch activities. Oversees promotional review, MLR/PMRC governance, marketing technology, agency and vendor management, congress planning, budgets, contracts, fulfillment, compliance, and integrated commercial execution. Partners cross-functionally with Marketing, Medical, Legal, Regulatory, Compliance, IT, and Commercial Operations to establish workflows, deploy approved content, track KPIs, manage launch plans, and ensure inspection readiness.

Lead cross-functional clinical operations project management: develop integrated project plans, track milestones, manage budgets/invoices/accruals, coordinate CROs and vendors, support risk assessment and audits, contribute to study documentation and senior leadership updates while fostering team alignment.

Lead global execution of clinical trials (Phase 2/3 preferred), manage CROs and vendors, oversee site selection/enrollment/supplies/budgets, identify and mitigate risks, author study documents, participate in CRF design and data monitoring, and manage/mentor clinical operations staff to ensure quality, compliance, and timely delivery.

Lead document control and QMS operations: manage controlled documents in the eQMS, archive GxP records, support audits, CAPA/change control, training, and inspection readiness. Develop metrics, dashboards (Smartsheet/Excel), and coordinate cross-functional quality systems improvements to ensure compliance with GCP/GMP requirements.

Lead preparation and filing of Form 10-Q/10-K and other SEC reports, manage XBRL tagging, oversee stock-based compensation (ASC 718), perform monthly journal entries and reconciliations (G&A accruals, cash & investments, fixed assets, leases), support SOX compliance, develop policies, and collaborate with legal/IR and cross-functional teams to streamline controls and reporting.

Lead global scientific communications and publication planning, oversee drafting and MLR-compliant publication execution, integrate the Scientific Communication Platform across deliverables, manage external medical writing vendors and budgets, and develop field-facing medical content and congress/advisory materials supporting Medical Affairs strategy.