Gossamer Bio

About Gossamer Bio

Summary Description The Sr. Manager / Assoc Dir, Clinical Supply will be responsible for ensuring the clinical supplies needed for assigned Gossamer clinical studies are provided on time and in accordance with protocol and applicable regulatory requirements. This includes management and oversight of the full clinical supply lifecycle: planning, forecasting, sourcing, packaging, labeling, distribution, return, and destruction. The successful applicant will collaborate closely as a member of cross-functional study teams that include CMC, Project Management, Clinical Operations, and RA/QA. This position will be based in our Dublin, Ireland office. Key Responsibilities Develop study specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply related training/instructional materials Manage supply planning/forecasting in collaboration with other GMP-supporting functional lines (e.g. Product Development, Analytical, QA, RA) to ensure alignment with study activity and timelines Design/review/coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements Provide packaging campaign requirements to vendors & approve associated GMP records with QA Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.) Collaborate with study team and vendors to assure proper distribution of supplies to study sites Monitor inventory levels at sites through the life of a trial proactively avoiding potential issues Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate Address temperature excursions, product complaints and ensure expiry extensions are provided to depot/sites as needed to support continued use Manage return and destruction of clinical supplies, with proper documentation of all steps Ensure appropriate documentation of IP supply activities is provided to the Trial Master File Work with cross-functional team to develop study-specific IRT specifications and requirements documents providing IP management perspective Perform unblinded monitoring of IRT inventory and functionality monitoring to assure resupply generation, etc. occur within defined specifications Experience & Education Bachelor's Degree in health or life sciences or equivalent with 5-7+ years' experience in the pharmaceutical/ biotechnology industry and 3 years of international clinical supply experience Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user testing and monitoring Proficiency in Microsoft applications, collaborative platforms (e.g., SharePoint, eRooms, Drop Box, Skype for Business), Electronic Data Capture systems, and Inventory Management systems Ability to establish and meet multiple concurrent priorities and deadlines Willingness and ability to travel domestically and internationally as needed Effective organizational skills, verbal and written communication, ability to present in group settings, commitment to quality, and the ability to think critically and creatively. Experience in working in a global environment a plus. Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

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