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.

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.

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 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.

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.

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.

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.

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.