Jobs at Beeline Medicines

Leads epidemiology strategy across the drug development portfolio, designing and overseeing observational studies, registries, natural history studies, systematic reviews, and real-world evidence analyses. Provides epidemiologic guidance for clinical development, safety, regulatory, medical affairs, market access, and commercial decisions. Authors regulatory and scientific materials, advises cross-functional teams, manages external partnerships, supports evidence planning and due diligence, and develops epidemiology standards and governance practices.

Supports Talent Acquisition and HR Operations across the employee lifecycle. Responsibilities include interview and hiring event logistics, staffing agency contracts, candidate reimbursements, background checks, onboarding, HRIS and Paylocity maintenance, benefits and leave tracking, offboarding, compliance records, reporting, policy administration, and employee inquiries. Coordinates with candidates, employees, vendors, Legal, Procurement, IT, and Accounting while maintaining accurate HR and recruiting data.

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.

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.

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.

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.

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.

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.

Manages GMP quality assurance oversight for external manufacturing and testing partners. Reviews batch records, deviations, CAPAs, and change controls; supports product release, audits, quality agreements, and health authority inspections. Applies GMP regulations and quality risk-management judgment across biologic and small-molecule manufacturing networks.

Leads global clinical supply chain strategy and execution across clinical programs, including forecasting, inventory planning, packaging, labeling, distribution, cold-chain integrity, trade compliance, and returns. Manages CDMOs, 3PLs, depots, and logistics partners while ensuring GMP, GDP, GCP, and regulatory compliance. Partners cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and Finance; develops SOPs, manages deviations and CAPAs, supports inspections, and builds scalable supply infrastructure in a pre-commercial biotech environment.

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.