What are the responsibilities and job description for the Associate Director, Clinical Supply position at Gossamer Bio?
JOB SUMMARY
The Associate Director, 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 planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies, as well as direct line management of other supporting clinical supply staff members. The successful applicant will collaborate closely as a member of cross-functional study teams that include Project Management, Clinical Operations, and RA/QA.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Develop study specific Investigational Product Supply Plans and supporting manuals/documents.
• Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate .
• Ensure appropriate documentation of IP supply activities is provided to the Trial Master File
• Manage supply planning/forecasting and label text development to ensure alignment with study activity and timelines .
• Monitor inventory levels at sites through the life of a trial proactively avoiding potential issues.
• Coordinate procurement, temperature excursions, product complaints and ensure expiry extensions are provided to depot/sites as needed to support continued use
• Collaborate with study team and vendors to assure proper distribution of supplies to study sites.
• Manage return and destruction of clinical supplies, with proper documentation of all steps.
• Serve as primary point of contact for third party packaging, distribution, and storage vendors.
• Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.)
• Work with cross-functional team to develop study-specific IXRS specifications and requirements documents providing IP management perspective and perform unblinded IXRS IP management.
JOB QUALIFICATIONS
Education, Certifications, Experience
• Bachelor’s Degree in health or life sciences or equivalent with 10 years’ experience in the pharmaceutical/ biotechnology industry
• 5 years’ experience managing an effective supply chain team.
• 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
Knowledge, Skills and Abilities
• 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.
SPECIAL WORKING CONDITIONS
Remote/Office environment / Domestic and International travel up to 15% may be necessary.
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.
The expected salary range for this position is $180,000 to $200,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/
Salary : $180,000 - $200,000
