Jobs at Bicara Therapeutics

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.

Support planning, execution, and management of clinical trials across APAC. Coordinate site start-up, regulatory submissions, vendor/CRO management, TMF/eTMF maintenance, data query resolution, monitoring and inspection readiness, trackers and budgets, and cross-functional communications to ensure compliant, timely study conduct.

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 strategy and operations for End User Services and digital workplace technologies, overseeing service desk, endpoint and mobile services, collaboration platforms, AV/conferencing, asset lifecycle, CMDB, and enterprise AI enablement. Build processes, KPIs, and governance; partner with security and infrastructure; drive AI adoption, training, and practical use cases; manage vendors and support office buildouts in a regulated biotech environment.

The Program Manager will oversee program management in cross-functional teams, develop project plans, manage timelines and budgets, and ensure effective communication across stakeholders in a biotech context.

The Senior Director will lead GMP Quality operations, supplier qualification, and ensure compliance with regulatory inspections while fostering a strong Quality culture.

The role involves building and leading the Quality Management Systems in a biotech company, ensuring compliance and operational efficiency in GxP activities, establishing governance, and fostering continuous improvement within clinical and commercial activities.

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.

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.

Provide executive-level administrative support to the Chief Commercial Officer and Chief People Officer, managing calendars, travel, meetings, onboarding, confidential documents, and cross-functional coordination. Drive logistics for onsite/offsite events, track action items, support special projects, and serve on the Administrative team in a fast-paced biotech environment.