Jobs at Beeline Medicines

Lead end-to-end biologics drug product CMC development including formulation, fill-finish process development, CDMO selection/oversight, regulatory submissions (IND/BLA), stability and release strategy, clinical supply planning, and cross-functional alignment to enable clinical and commercial readiness.

Lead analytical method development, qualification, and validation for small-molecule drug substance and product. Own analytical control strategy, stability programs, forced degradation, method transfers, and regulatory analytical sections (IND/IMPD/NDA). Manage technical oversight of contract labs and CDMOs, ensure GMP and data integrity, support manufacturing analytics, and drive specifications, release testing, and cross-functional alignment as the primary analytical lead for assigned programs.

Provide strategic statistical leadership across Phase I-III clinical programs: design trials, author SAPs, oversee randomization and analysis, ensure CDISC-compliant delivery (SDTM/ADaM), lead regulatory statistical sections and interactions (IND/NDA/BLA/MAA), manage CRO statistical partners, build Biometrics function, and serve as a cross-functional quantitative advisor shaping program and regulatory strategy.

Senior, field-based clinical development professional responsible for building investigator and site relationships, leading site identification and feasibility, supporting site activation, enrollment, and retention, capturing field intelligence, partnering with Medical Affairs/MSLs, and driving execution across a multi-state territory to support immunology and inflammation clinical trials.

Serve as the primary IT strategist and owner for assigned business functions in a clinical‑stage biopharma. Translate business priorities into technology roadmaps, manage enterprise application platforms and vendor relationships, ensure GxP/SOX-compliant operations and validation, drive capability maturity planning, lead integrations with partners, and act as embedded IT partner to functional leaders and regulatory inspections.

Support day-to-day accounting operations for a clinical-stage biotech including monthly close, journal entries, account reconciliations, accounts payable, accruals for clinical programs, audit support, vendor management, and process improvement in a hybrid, fast-paced finance team.

Field-based senior clinical development role to build and manage investigator and site relationships across Eastern Europe, lead site identification and feasibility, support site activation, enrollment and retention, capture field intelligence, partner with Medical Affairs and CROs, and represent the company at scientific meetings. Requires independent territory management and frequent travel to drive study execution and optimize site performance.

Lead regulatory strategy for immunology & inflammation programs from IND/CTA through NDA/BLA/MAA. Own US regulatory interactions, prepare FDA meeting materials and high-quality submissions, align cross-functional teams, assess and mitigate regulatory risk, and support ex-US regulatory activities (EMA, CTAs).

Lead and execute integrated internal and external communications for a clinical-stage biotech, managing media, executive communications, social and digital channels, pipeline and product milestone messaging, internal employee communications, agency partners, and measurement practices to shape company reputation and stakeholder relationships.

Lead operational planning and execution of global Phase 1-4 immunology clinical trials. Manage CROs/vendors, site selection and enrollment, timelines, risk mitigation, data readiness, regulatory submissions, inspection readiness, and mentor Clinical Operations staff while ensuring GCP/ICH and SOP compliance.

Field-based clinical development lead managing investigator and site relationships across Western Europe. Responsibilities include site identification and feasibility, investigator engagement, supporting site activation, enrollment and retention, capturing field intelligence, collaborating with Medical Affairs/MSLs and CROs, and developing site engagement strategies to optimize trial execution and diverse patient enrollment.

Own month-end, quarter-end, and year-end close activities: GL management, journal entries, account reconciliations, and financial statements. Maintain complex schedules (prepaids, accruals, fixed assets, ASC 842 leases), manage AP/vendor payments, support external audits, ensure SOX/internal control compliance, and drive process improvements while partnering cross-functionally.

Lead integrated global regulatory strategy for early-stage immunology and inflammation programs (pre-IND through clinical phases), manage Health Authority interactions, develop regulatory plans and timelines, align regulatory input with clinical/CMC/nonclinical teams, prepare IND/CTA/NDA/BLA and pediatric plans, evaluate expedited pathways, support due diligence, and build regulatory infrastructure and best practices.

Lead GCP Quality Assurance strategy and operations for clinical development. Oversee QA systems, vendor/CRO oversight, risk-based audits, inspection readiness, regulatory inspection support, and embedding quality-by-design across late-stage clinical programs.

Lead end-to-end global clinical supply chain for IMPs across small molecules and biologics: demand forecasting, packaging/labeling, IRT/IVRS-driven planning, cold-chain distribution, 3PL/depot governance, import/export and trade compliance, SOPs and inspection readiness, supply exception investigations and CAPA, and cross-functional alignment with CMC, Clinical Operations, Quality, and vendors to ensure timely, GMP/GDP-compliant delivery to clinical sites.

Field-based senior clinical development professional responsible for building and managing investigator and site relationships, supporting site identification and activation, driving enrollment and retention, providing field intelligence to Clinical Development and Medical Affairs, and representing the company at scientific meetings across a multi-state territory.

Serve as Global Regulatory Lead and US Regulatory Lead for assigned programs, developing and executing global regulatory strategy, leading IND/CTA/NDA/MAA submissions, managing health authority interactions, ensuring compliance and lifecycle management, supporting indication expansion, and overseeing consultants and future direct reports while coordinating cross-functional teams.

Field-based senior clinical development professional responsible for building and managing investigator and site relationships across Japan/APAC to support clinical trial site identification, activation, enrollment, and retention. Acts as primary site-facing liaison, provides site feasibility and operational assessments, partners with Medical Affairs and CROs, captures field intelligence, and implements engagement strategies to optimize study execution and diverse patient recruitment.

Provide medical and scientific oversight of global drug safety activities including signal detection, benefit-risk assessment, medical case review, and aggregate safety reporting. Author periodic safety reports, collaborate with clinical, regulatory, and medical affairs teams, contribute to labeling and risk management, and ensure compliance with global PV regulations for immunology and inflammation programs.

Senior, field-based clinical development professional who builds and manages investigator and site relationships across a multi-state territory to support site identification, activation, enrollment, retention, and trial execution for immunology and inflammation programs. Serves as primary site liaison, conducts feasibility, provides site support and training, captures field intelligence, partners with Medical Affairs/MSLs, and implements site engagement strategies to optimize study performance.