Beeline Medicines

Beeline Medicines

Director, Clinical Supplies & Logistics

United States · Director

Sponsorship not specified$215k-$227kDetected 20 days ago
GCPForecastingSupply ChainLogisticsERPGMPFDA RegulatoryLeadershipCommunicationCollaborationDemand Planning

About the role

  • The Director, Clinical Supplies & Logistics is a senior operational leader responsible for the end-to-end planning, execution, and oversight of clinical supply chain activities supporting the company's global clinical development programs.
  • Remote - This position is designated as remote
  • The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Responsibilities

  • Design and lead the end-to-end clinical supply chain strategy for all active and planned clinical programs, encompassing demand forecasting, inventory planning, clinical packaging and labeling, IRT/IVRS configuration, distribution, and returns/destruction.
  • Own the global IMP distribution network, including selection and governance of third-party logistics (3PL) providers, cold chain carriers, and depot partners across North America, Europe, and global regions; ensure temperature-controlled supply chain integrity from CDMO release through site delivery.
  • Lead clinical supply planning and demand forecasting across multiple concurrent trials, using IRT/IVRS data and enrollment modeling to optimize inventory levels, minimize waste, and prevent supply disruptions to clinical sites.
  • Manage import/export logistics and global trade compliance for IMP shipments across all active clinical geographies, including coordination of regulatory import permits, customs documentation, and country-specific distribution authorizations.
  • Establish and govern relationships with CDMOs, 3PLs, comparator drug suppliers, and specialty logistics vendors; define performance expectations, conduct business reviews, and manage escalations to ensure supply reliability.
  • Build and maintain clinical supply chain SOPs, batch disposition records, chain-of-custody documentation, and reconciliation processes in alignment with ICH E6 (GCP), GMP, and GDP expectations; author and update pharmacy manuals, Investigator Brochure supply sections, and site handling guidance to ensure clinical site readiness across all active studies.
  • Lead investigation of supply chain exceptions and deviations, including root cause analysis, CAPA development, implementation, and closure; ensure all supply-related non-conformances are resolved in a timely, GMP-compliant manner and escalated appropriately.
  • Perform other duties and responsibilities as assigned
  • Partner with Quality Assurance to ensure clinical supply chain operations meet GDP/GMP requirements; lead or support regulatory agency inspections, internal audits, and CDMO quality reviews as they relate to clinical supply.
  • the incumbent will be expected to travel to Beeline Medicines' offices on a periodic basis to support in-person collaboration, team engagement, and business operations.

Nice to have

  • 10+ years of clinical supply chain experience in the pharmaceutical or biopharmaceutical industry, with at least 3 years in a leadership role with direct accountability for global clinical supply operations.
  • Demonstrated expertise in end-to-end clinical supply chain management, including demand planning, IMP packaging and labeling, IRT/IVRS systems, global distribution, cold chain logistics, and depot management.
  • Deep knowledge of global GMP, GDP, and GCP regulations as they apply to clinical supply chain operations, including FDA 21 CFR Parts 211/312, EU GMP Annex 13, and ICH E6(R2)
  • familiarity with country-specific import/export requirements across clinical geographies.
  • Familiarity with clinical supply chain management for both small molecules and biologics/large molecules, including specific cold chain and stability considerations for protein-based therapeutics.
  • Proficiency with supply chain management tools, ERP/CTMS systems, and clinical supply planning platforms;
  • Strong written communication skills, with experience producing high-quality supply chain status reports, risk registers, executive summaries, and regulatory-facing supply documentation.
  • Skilled facilitator with experience leading cross-functional supply chain review meetings, risk escalation discussions, and vendor business reviews with clarity, structure, and decisive follow-through.

Compensation

  • $214,849 - $227,040 USD
  • Equal Employment Opportunity:
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.
  • The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired.
  • Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law.
  • A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Benefits

  • We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.
  • Competitive health and wellness coverage (structure and premiums vary by country)
  • Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
  • Specific benefit details applicable to your country or region will be provided during the offer process.
  • Benefits may include, but are not limited to:
  • Flexible work arrangements / hybrid schedule
  • Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

Company info

  • Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.
  • With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.
  • Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.

Equal opportunity

  • If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.
  • We are committed to providing equal access to all candidates.
  • Beeline Medicines is an Equal Opportunity Employer.
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.
Apply directly at Beeline Medicines →Create a free account for alerts like thisView Beeline Medicines immigration profile

This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.