Jobs 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.

Drafts, reviews, and negotiates commercial agreements, including confidentiality, master services, CRO/vendor, and consulting agreements. Partners with Procurement, R&D, and other teams to manage contracting timelines, advise on contractual risk, maintain templates and negotiation playbooks, support contract lifecycle management, and assist with due diligence for business development and licensing transactions. Escalates complex issues and drives scalable legal process improvements.

Leads clinical pharmacology strategy across development programs, directing PK/PD study design, dose selection, population pharmacokinetics, exposure-response modeling, and simulation. Authors regulatory submission content, advises cross-functional teams, oversees CROs and modeling vendors, and represents clinical pharmacology in FDA and EMA interactions. The role also supports drug-drug interaction and special-population studies, due diligence, licensing evaluations, and regulatory defense of clinical pharmacology strategies.

Manages enterprise procurement and outsourcing activities, including sourcing events, contract and pricing negotiations, vendor qualification, performance management, risk assessments, site contracts, supplier onboarding, spend analysis, and compliance monitoring. Partners with R&D, Clinical, Tech Ops, Legal, Finance, and other stakeholders to develop sourcing strategies, achieve savings, maintain procurement systems, and support business priorities.

Leads clinical data management across clinical programs from study start-up through database lock. Oversees study documents, EDC builds, data cleaning, coding, external data reconciliation, database releases, CRO and vendor performance, and inspection readiness. Partners with cross-functional teams to manage data quality, regulatory compliance, timelines, and risk mitigation. Requires expertise in CDISC standards, clinical data systems, medical coding, database lock processes, and outsourced clinical data management.

Supports scientific communications strategy across a biotech portfolio, leading publication planning, congress activities, and scientific content development. Manages abstracts, manuscripts, posters, presentations, and medical meeting deliverables while ensuring compliance with GPP2022, ICMJE, and company standards. Translates clinical and translational data into clear materials for internal and external audiences, coordinates cross-functional stakeholders, manages timelines and vendors, and supports advisory boards and investigator meetings.

Build and manage investigator and clinical site relationships across Brazil and LATAM. Lead site identification, feasibility, activation, enrollment, retention, and engagement strategies for immunology and inflammation clinical trials. Serve as a scientific liaison to investigators, support protocol discussions and training, provide field intelligence to internal teams, monitor site performance, mitigate enrollment risks, and collaborate with Medical Affairs, CROs, and research sites.

Leads investigator and clinical-site relationships across Mexico and LATAM for immunology and inflammation trials. Responsibilities include site identification and feasibility, investigator engagement, site activation, enrollment and retention support, field intelligence, site performance monitoring, risk mitigation, and collaboration with Clinical Development, Clinical Operations, Medical Affairs, CROs, and MSLs. The role is field-based, requires extensive travel, scientific credibility, independent territory management, and support for clinical trial execution.

Leads investigator and clinical site relationships across Argentina, Chile, and assigned LATAM territories for immunology and inflammation clinical trials. Responsibilities include site identification and feasibility, investigator engagement, site activation, enrollment and retention support, field intelligence, protocol discussions, site training, performance monitoring, risk mitigation, and collaboration with Clinical Development, Clinical Operations, Medical Affairs, CROs, and MSLs. The role is field-based, highly independent, externally focused, and requires extensive travel.

Leads investigator and clinical-site relationships across China and APAC for immunology and inflammation trials. Responsibilities include site identification and feasibility, investigator engagement, site initiation and training, enrollment and retention support, field intelligence, site performance monitoring, risk mitigation, and collaboration with Clinical Development, Clinical Operations, Medical Affairs, CROs, and research sites. The role is field-based, highly autonomous, externally focused, and requires extensive travel.

Leads investigator and clinical site relationships across India and APAC for immunology and inflammation clinical trials. Responsibilities include site identification and feasibility, investigator engagement, site initiation support, enrollment and retention optimization, clinical landscape intelligence, site performance monitoring, and risk mitigation. The role partners with Clinical Development, Clinical Operations, Medical Affairs, CROs, investigators, and site staff, while representing the company at scientific meetings and conducting regular field engagement.

Leads and develops a regional team of Clinical Engagement Leads managing investigator and clinical trial site relationships. Oversees site feasibility, activation, enrollment strategy, investigator-initiated studies, compliance, CRM data quality, and escalation resolution. Partners with Clinical Operations, Clinical Development, Medical Affairs, and HR while communicating field intelligence and performance metrics to senior leadership. The role is field-based across Europe and Asia, requiring extensive travel and occasional evening or weekend availability.

Provide strategic leadership and operational oversight of GCP Quality Assurance for clinical programs. Own GCP quality systems, CRO/vendor oversight, audit strategy, inspection readiness, risk-based QA, quality metrics, SOPs, CAPA, and build/mentor QA capability while partnering cross-functionally to ensure compliance and inspection readiness.

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.

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.

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.

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.