Senior Manager, Clinical Supply Chain

Hybrid + Bonus + Equity + 401(k) Plan and moreThis Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume.Salary: $145,000 - $185,000 per yearA bit about us:We are a publicly traded biotherapeutics company developing treatments for those suffering from chronic diseases.Why join us?

• Competitive Compensation Package
• Annual Bonus
• Hybrid Schedule
• 401(k) Retirement Plan
• Equity
• Health Insurance Benefits

Job DetailsWe are seeking a Manager/Senior Manager of Clinical Supply Chain to execute activities in support of early-to-late-stage clinical trials. You will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. The ideal candidate will enjoy working in a fast-paced environment that requires establishing relationships across CMC, Clinical, Program Management, Regulatory and Quality. Responsibilities:

• Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols
• Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs
• Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information
• Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management
• Support clinical supply and logistics planning in support of global regulatory filings
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs
• Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers
• Verify with Quality the accuracy within blinded studies’ drug release, shipments & IRT setup
• Identify and execute process improvements through report development and SOPs
• Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs
• Serve as person-in-plant (PIP) during label and packaging campaigns
• 20-25% travel in support of diligence and campaign execution at the CPOs

Qualifications:

• Bachelor’s or Master’s in a scientific discipline with 5+ years of relevant experience in clinical supply chain and logistics
• Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Experience with clinical supply chain involving cold chain products is a plus
• Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus
• Demonstrated experience managing import/export for clinical studies in US, Canada and EU
• Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
• In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies
• Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment

Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button._{Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy}