Teams at Beeline Medicines

Leads end-to-end CMC drug product development for biologics, including formulation, fill-finish, process scale-up, clinical supply, regulatory submissions, and CDMO oversight. The role manages formulation optimization, stability, container-closure selection, device development, process characterization, technology transfer, validation readiness, and FDA/EMA interactions. It partners across analytical development, drug substance, quality, clinical operations, and supply chain while applying QbD, DoE, and risk management principles. The director also supports portfolio planning, due diligence, and executive-level technical decision-making.

Leads global regulatory strategy for immunology and inflammation development programs from pre-IND through post-approval. Responsibilities include regulatory pathway planning, IND/CTA/NDA/BLA submissions, FDA and EMA interactions, Health Authority meeting preparation, integrated regulatory development plans, expedited pathway evaluation, cross-functional development guidance, regulatory intelligence, due diligence, and resource planning.

Leads biostatistical strategy for clinical development programs from protocol design through clinical study reports and regulatory submissions. Responsibilities include developing statistical analysis plans, sample size and power calculations, randomization schemes, and overseeing tables, listings, and figures produced internally or by CROs. Collaborates with Clinical, Regulatory, and Data Management teams, ensures ICH and regulatory compliance, provides statistical input for submissions and publications, and communicates complex findings to stakeholders and senior leadership.