Jobs at Kardigan

Leads Kardigan’s statistical programming organization and portfolio delivery across clinical development. Oversees regulatory submissions, CDISC-compliant datasets and outputs, quality systems, inspection readiness, vendors, budgets, and validated computing environments. Establishes programming standards, SOPs, automation, reusable tools, and operational strategy while partnering with Biostatistics, Clinical Development, Data Management, Regulatory, Quality, and IT. Builds and develops the internal team and provides senior leadership for submission planning and health-authority interactions.

Leads patient and revenue forecasting across a biopharmaceutical portfolio, including projection, valuation, scenario, and patient-flow models. Partners with Finance, Strategy, Commercial, Clinical, Medical Affairs, and Business Development to support planning, launches, market access, supply, and investment decisions. Evaluates market research, claims, epidemiology, payer, pricing, and competitive data; governs forecast assumptions and accuracy; presents recommendations to senior leadership; and mentors junior analysts.

Leads end-to-end clinical development strategy and execution for the Danicamtiv program. Owns clinical development plans, protocol design, late-stage trial execution, regulatory strategy, benefit-risk decisions, and program budgets and timelines. Provides matrix leadership across clinical, regulatory, biometrics, and operations teams; manages clinical development physicians and scientists; and represents the program with executives, regulators, investigators, and key opinion leaders. Ensures compliance, patient safety, scientific integrity, and successful progression toward registration.

Leads end-to-end clinical development strategy and execution for the Tonlamarsen program. Owns the clinical development plan, protocol design, late-stage trial execution, regulatory strategy, benefit-risk decisions, and program timelines. Provides matrix leadership across clinical, regulatory, biometrics, and operations teams; manages clinical development physicians and scientists; supports safety surveillance, medical affairs, executive reporting, and external scientific engagement. Requires substantial Phase 2b/3 biotech experience and physician-level drug development expertise.

Manages accounting operations, general ledger activities, GAAP compliance, month-end and year-end close, reconciliations, financial reporting, payroll accounting, audits, and process improvements. Oversees NetSuite and related system integrations, supports accounts payable and purchasing, analyzes clinical trial accruals, and partners with HR, IT, and FP&A to improve financial accuracy and operational efficiency.

Leads integrated product strategy for an investigational cardiovascular therapy, including target product profiles, value propositions, competitive assessments, forecasting, scenario analysis, launch readiness, market access, and go-to-market planning. Partners with clinical, regulatory, commercial, and business development teams, prepares governance recommendations, and drives cross-functional alignment through influence.

Leads the creation of Kardigan’s Clinical Trial Optimization capability, covering feasibility, enrollment forecasting, protocol optimization, study start-up, site activation, and patient engagement. Builds the operating model and team, validates CRO assumptions, develops tools and benchmarks, improves study predictability, and owns clinical operations requirements for AI and digital trial solutions. Partners across clinical, medical, development, and digital teams while overseeing vendors, governance, performance measurement, and continuous improvement.

Lead regional cardiovascular clinical trial planning and execution, driving timelines, budgets, vendor/CRO oversight, site start-up, enrollment strategies, compliance with ICH-GCP, data cleaning, risk management, regulatory/IRB interactions, and direct people management to deliver study outcomes.

Lead market access strategy for late-stage cardiovascular therapies from pre-launch through commercialization. Develop payer value propositions, pricing and contracting frameworks, formulary strategies, patient services, channel plans, and government policy initiatives. Build payer and PBM relationships, guide HEOR evidence generation, oversee launch readiness, establish access performance metrics, and grow a high-performing market access team.

Leads integrated demand, supply, inventory, and clinical supply planning across an outsourced biotech manufacturing network. Builds forecasts and supply plans, monitors inventory and capacity risks, coordinates CDMO execution, develops scenario analyses, and provides dashboards and recommendations for cross-functional governance. The role improves planning processes and supports clinical development, launch readiness, and patient supply continuity.

The Director, Clinical Trial Liaison develops investigator and research-site relationships to support clinical trial feasibility, startup, recruitment, retention, and execution. Responsibilities include providing regional operational insights, communicating scientific trial information, attending site visits and investigator meetings, resolving and escalating site issues, supporting audits and inspections, tracking metrics, and collaborating with Clinical Operations, Medical Affairs, Clinical Development, and CRO teams. The role covers the western region and requires travel of up to 70%.

Leads CMC regulatory strategy and execution for late-stage clinical assets through marketing approval. Responsibilities include managing global submissions, health authority interactions, regulatory guidance, manufacturing and quality change assessments, compliance with FDA, EMA, and ICH requirements, and development of regulatory processes and SOPs. The role collaborates extensively with cross-functional teams and may manage internal or external staff.

Leads CMC regulatory strategy and execution for late-stage pharmaceutical programs through clinical development and marketing approval. Responsibilities include global submissions, FDA/EMA/ICH compliance, health authority interactions, manufacturing and quality change assessments, regulatory guidance, SOP development, and staff management. The role collaborates extensively with cross-functional teams and supports multiple development programs in a fast-paced environment.

The Executive Director of Global Site Management leads clinical trial operations, optimizing site management, enrollment, and strategic partnerships globally while ensuring compliance and high-quality data.

The Director, Clinical Trial Liaison develops relationships with clinical trial investigators to facilitate recruitment in cardiovascular studies, providing operational insights and supporting clinical trial execution.

Manage CROs and vendors to deliver cardiovascular clinical studies on time, within budget, and compliant with SOPs, FDA and ICH-GCP. Support trial planning, timelines, budgets, oversight plans, risk mitigation, inspection readiness, CAPA, and cross-functional coordination for study execution and reporting.

Lead development and execution of global procurement strategy, build scalable procurement operations, drive strategic sourcing, negotiate contracts, manage supplier performance, ensure compliance and controls, implement procurement systems and AI-enabled tools, and partner cross-functionally to deliver cost savings and operational excellence.

Serve as the People & Culture site lead and strategic HR business partner for South San Francisco, advising senior scientific leaders on organizational design, workforce planning, succession, employee relations, performance management, and leadership development. Drive culture, engagement, and People & Culture program execution in partnership with centers of excellence to support rapid growth.