Jobs at Bicara Therapeutics

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 HCP marketing strategy and execution for Ficerafusp Alfa in 1L R/M HPV-negative HNSCC, develop HCP messaging and launch plans across channels, manage agencies and budgets, align cross-functionally with medical, commercial, sales, and compliance, engage KOLs, and support training and omnichannel digital strategies for US launch readiness.

Lead global market access strategy and organization for Bicara's oncology asset, overseeing payer engagement, pricing, reimbursement, trade/distribution, patient support, HEOR alignment, and cross-functional launch readiness to maximize patient access and product value.

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.

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.

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 and build a scalable Quality organization to support transition from clinical development to commercial manufacturing. Own enterprise quality strategy, regulatory inspection readiness, oversight of CMOs/CROs, quality systems (batch disposition, deviations, document control), and cross-functional alignment. Hire and mentor QA staff, manage quality budgets, and ensure global compliance with FDA/EMA and GxP requirements for biologics.

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.