Senior Manager, Clinical Supply Chain (Biologics)

Job Title: Senior Manager, Clinical Supply Chain (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview: We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.

Key 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 6+ 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

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $161,0000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.