OVERVIEW
Star Therapeutics, Inc. (Star) is a clinical-stage biotechnology company focused on transforming the lives of patients with serious and life-threatening rare diseases. Star has a strong pipeline of therapeutics programs. Its management team and board have demonstrated track records of success discovering and developing novel medicines for patients, and the company is backed by top-tier biotech investors. The company was founded in 2018 and is located in South San Francisco, CA.
POSITION SUMMARY
The Manager/Sr Manager of Clinical Supply Chain will support the clinical operations team and cross-functional teams by owning end-to-end clinical supply chain responsibilities. The ideal candidate will have proven ability to clearly define objectives and priorities, establish milestones, anticipate, and mitigate risks while maintaining strong attention to detail. This position will be reporting to the VP, Clinical Operations.
RESPONSIBILITIES
• Support end –to-end clinical supply packaging responsibilities including but not limited to:
o Design and implementation of strategic plans to forecast, distribute and supply study drug to global clinical trials using sound supply chain techniques
o Translate clinical study synopsis/protocols into actionable drug forecasts
o Inventory management
o Develop and manage label text, coordinate translations and proofing processes.
o Set up, manage and monitor global distribution networks based on study requirements. Ensure required Import/Export documentation is available and continuous drug supply to global clinical studies
• Provide effective vendor oversight. Manage external vendor relationships ensuring timelines are met
• Review vendor contracts and manage budgeting and invoicing process
• Participate in Clinical Study Execution meetings as Supply Chain Subject Matter Expert
• Effective cross-functional collaborator and communicator. Interface with CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables
• Develop and establish Standard Operating Procedures (SOP’s) as required Reviews and revises departmental SOPs to streamline and to improve current practices • Maintain documents according to guidelines and relevant procedures
• Proactively identify potential supply chain issues, provides analysis and recommends solutions
• Multi-task and manage complexity and change
SKILLS & ABILITIES
• Demonstrated experience with clinical trial process from a supply chain perspective from study start up through completion, including shipping
• Demonstrated experience in inventory management and forecasting drug supply needs (Global experience preferred)
• Familiarity with various clinical trial designs (randomized, double-blind, etc.)
• Working knowledge of GMP and GCP
• Ability to manage complexity and ambiguity in a fast-paced work environment
• Experience working with external vendors and collaborators, with strong interpersonal capabilities
• Ability to manage multiple projects simultaneously
• Excellent verbal and written communication (technical writing, PowerPoint)
EDUCATION & PROFESSIONAL EXPERIENCE
• Bachelor’s Degree in scientific discipline (Advanced degree preferred)
• Minimum 5 years of relevant industry experience with pharmaceutical clinical supply management. Rare Disease experience a plus
The salary range for this position is $145,000-$170,000. The range provided in this job posting represents the typical range for candidates hired in California. Factors that may be used to determine your actual salary may include your education, experience, knowledge, skills, abilities, the market data for your work location, and a comparison to other employees already in the role. Please note that the compensation details listed in this posting reflect the base salary only, and do not include bonus, equity, or benefits.