(Associate) Director, Clinical Supply Chain
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
The (Associate) Director, Clinical Supply Chain will develop and implement strategies to deliver Clinical Trial Materials (CTM) in support of several clinical programs. Reporting to the Senior Director, Clinical Supply Chain, this role will build collaborative relationships with internal departments and third-party providers to ensure clinical supply. The position requires strong attention to detail for the development and maintenance of clinical forecasts, inventory databases, and IRT systems, providing daily oversight of clinical supplies. Travel to CDMOs domestically and internationally may be required. Responsibilities
Develop and update clinical supply strategies as needed to meet corporate demands Develop/maintain strong collaborative relationships with internal departments and external CDMOs Identify potential supply chain risks and develop & implement negotiated mitigation strategies Manage study/program budget, contracts and change orders and track spend against budget Drive process optimization, scalability, and implementation of best practices and systems Execution
Develop and working with Clinical, regularly update forecast/demand plans for finished goods and work with Manufacturing to develop production schedules which meet clinical demand Collaborate with Quality, Clinical, CMC and external CDMOs to develop and approve clinical labels Manage CDMO packaging/labeling schedules to ensure availability of clinical supplies Interact regularly with third-party providers to manage logistics & licenses required to ship materials from manufacturing to bulk storage facilities, courier depots and investigator sites Work with CMC and QA to facilitate document transfer required for CTM/QP release by CDMOs Manage and track clinical supply inventory either manually or through an Interactive Response Technology (IRT) system Manage Product Recovery pending investigation of CTM from investigator sites as needed Support supply risk mitigation planning (e.g., shortages, delays, temperature excursions) Collaboration
Contribute to SOP development, maintenance, and continuous improvement initiatives Effectively collaborate and communicate across multiple functional areas, bringing a sufficient breadth of knowledge Monitor shelf-life and expiry dating and coordinate retest extension with analytical team to ensure continuous supply Manage investigation, reporting and communication of outcomes from temperature excursions and product complaints Author and/or review supply chain sections of regulatory submissions If required, participate as SME in audits or for-cause inspection of CDMOs Contribute as a SME to CDMO selection and approval process and review of associated Master Service Agreements (MSA) and Quality Agreements for clinical supply services Represent Supply Chain in Clinical and CMC Sub Team meetings Qualifications
Bachelor’s degree in engineering or science is required 8-10 years of biotech/pharma industry experience in clinical supply with significant international experience is required Experience in all aspects of clinical supply chain as well as a deep understanding of GMP/GDP Requires a strong understanding of managing groups, CMOs and CDMOs Experience overseeing or managing blistering and walleting packaging processes required Proven background in working with small molecule modality required Demonstrated experience operating within a commercial drug product environment Strong organizational, analytical, decision-making and interpersonal skills Ability to work on multiple projects independently in a fast-paced dynamic environment Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products Excellent organizational skills, project management skills and detail-oriented leadership approach Ability to thrive in a small company culture and assist in creating and implementing processes Willing and able to travel both domestically and internationally Additional Requirements
Travel up to 20% and remote work arrangement in the United States
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The (Associate) Director, Clinical Supply Chain will develop and implement strategies to deliver Clinical Trial Materials (CTM) in support of several clinical programs. Reporting to the Senior Director, Clinical Supply Chain, this role will build collaborative relationships with internal departments and third-party providers to ensure clinical supply. The position requires strong attention to detail for the development and maintenance of clinical forecasts, inventory databases, and IRT systems, providing daily oversight of clinical supplies. Travel to CDMOs domestically and internationally may be required. Responsibilities
Develop and update clinical supply strategies as needed to meet corporate demands Develop/maintain strong collaborative relationships with internal departments and external CDMOs Identify potential supply chain risks and develop & implement negotiated mitigation strategies Manage study/program budget, contracts and change orders and track spend against budget Drive process optimization, scalability, and implementation of best practices and systems Execution
Develop and working with Clinical, regularly update forecast/demand plans for finished goods and work with Manufacturing to develop production schedules which meet clinical demand Collaborate with Quality, Clinical, CMC and external CDMOs to develop and approve clinical labels Manage CDMO packaging/labeling schedules to ensure availability of clinical supplies Interact regularly with third-party providers to manage logistics & licenses required to ship materials from manufacturing to bulk storage facilities, courier depots and investigator sites Work with CMC and QA to facilitate document transfer required for CTM/QP release by CDMOs Manage and track clinical supply inventory either manually or through an Interactive Response Technology (IRT) system Manage Product Recovery pending investigation of CTM from investigator sites as needed Support supply risk mitigation planning (e.g., shortages, delays, temperature excursions) Collaboration
Contribute to SOP development, maintenance, and continuous improvement initiatives Effectively collaborate and communicate across multiple functional areas, bringing a sufficient breadth of knowledge Monitor shelf-life and expiry dating and coordinate retest extension with analytical team to ensure continuous supply Manage investigation, reporting and communication of outcomes from temperature excursions and product complaints Author and/or review supply chain sections of regulatory submissions If required, participate as SME in audits or for-cause inspection of CDMOs Contribute as a SME to CDMO selection and approval process and review of associated Master Service Agreements (MSA) and Quality Agreements for clinical supply services Represent Supply Chain in Clinical and CMC Sub Team meetings Qualifications
Bachelor’s degree in engineering or science is required 8-10 years of biotech/pharma industry experience in clinical supply with significant international experience is required Experience in all aspects of clinical supply chain as well as a deep understanding of GMP/GDP Requires a strong understanding of managing groups, CMOs and CDMOs Experience overseeing or managing blistering and walleting packaging processes required Proven background in working with small molecule modality required Demonstrated experience operating within a commercial drug product environment Strong organizational, analytical, decision-making and interpersonal skills Ability to work on multiple projects independently in a fast-paced dynamic environment Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products Excellent organizational skills, project management skills and detail-oriented leadership approach Ability to thrive in a small company culture and assist in creating and implementing processes Willing and able to travel both domestically and internationally Additional Requirements
Travel up to 20% and remote work arrangement in the United States
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