Clinical Supply Chain Manager - United Therapeutics
Research Triangle Park, NC
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Clinical Supply Chain Manager will manage assigned study supply, availability and delivery of Clinical Trial Material to support all United Therapeutics clinical trials. This role will facilitate processes to help assure uninterrupted clinical trial material supply. This is a hybrid position with 4 days a week onsite in our RTP, NC office and 1 day a week work from home.
+ Forecast, track, and manage clinical trial material for manufacturing and supply chain, including raw materials coordination, manufacturing operations, packaging, labeling, inventory maintenance, and distribution to clinical sites
+ Ensure uninterrupted supplies throughout the duration of clinical studies
+ Collaborate with the Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
+ Coordinate with CMC (Chemistry, Manufacturing, and Controls) and Quality Assurance (QA) partners to manage technical and quality issues, support the release of clinical supplies, and ensure regulatory submissions are up to date.
+ Oversee clinical trial material vendors at a high level
+ Provide high-level feedback on the development and implementation of IVRS/IWRS/IRT systems
+ Organize and maintain clinical labels in compliance with regulatory standards
+ Ensure all activities are managed to a set budget
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree, preferably in a science related field
+ 8+ years of relevant experience, including experience working on cross-functional projects and business process improvements in a collaborative environment with a bachelor’s degree
+ 6+ years of relevant experience, including experience working on cross-functional projects and business process improvements in a collaborative environment with a master’s degree
+ 6+ years of experience in clinical supplies, logistics, or a related field within the pharmaceutical/clinical research industry
+ Ability to prioritize, organize and manage multiple projects simultaneously
+ Working knowledge of GCP and GMP environments and requirements
+ Familiarity with clinical trial packaging/labeling and/or distribution
+ Strong customer service and cross-functional interpersonal skills
+ Working knowledge of clinical trials and the drug development process
+ Excellent oral and written communication
+ Strong proficiency in MS Office suite, including Word, Excel, and PowerPoint
+ Experience managing and overseeing Clinical Trial Material Vendors
+ Experience with global distribution and familiarity with logistics
+ Experience developing and implementing IVRS/IWRS systems
+ Willingness to travel up to 10% to various meetings or client sites, including overnight trips
Preferred Qualifications
+ Master’s degree
+ Analytical Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem
+ Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals
+ Presentation Skills - ability to give professional and concise presentations at internal and external meetings
+ Project Management experience
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Clinical Supply Chain Manager will manage assigned study supply, availability and delivery of Clinical Trial Material to support all United Therapeutics clinical trials. This role will facilitate processes to help assure uninterrupted clinical trial material supply. This is a hybrid position with 4 days a week onsite in our RTP, NC office and 1 day a week work from home.
+ Forecast, track, and manage clinical trial material for manufacturing and supply chain, including raw materials coordination, manufacturing operations, packaging, labeling, inventory maintenance, and distribution to clinical sites
+ Ensure uninterrupted supplies throughout the duration of clinical studies
+ Collaborate with the Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
+ Coordinate with CMC (Chemistry, Manufacturing, and Controls) and Quality Assurance (QA) partners to manage technical and quality issues, support the release of clinical supplies, and ensure regulatory submissions are up to date.
+ Oversee clinical trial material vendors at a high level
+ Provide high-level feedback on the development and implementation of IVRS/IWRS/IRT systems
+ Organize and maintain clinical labels in compliance with regulatory standards
+ Ensure all activities are managed to a set budget
+ Perform other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree, preferably in a science related field
+ 8+ years of relevant experience, including experience working on cross-functional projects and business process improvements in a collaborative environment with a bachelor’s degree
+ 6+ years of relevant experience, including experience working on cross-functional projects and business process improvements in a collaborative environment with a master’s degree
+ 6+ years of experience in clinical supplies, logistics, or a related field within the pharmaceutical/clinical research industry
+ Ability to prioritize, organize and manage multiple projects simultaneously
+ Working knowledge of GCP and GMP environments and requirements
+ Familiarity with clinical trial packaging/labeling and/or distribution
+ Strong customer service and cross-functional interpersonal skills
+ Working knowledge of clinical trials and the drug development process
+ Excellent oral and written communication
+ Strong proficiency in MS Office suite, including Word, Excel, and PowerPoint
+ Experience managing and overseeing Clinical Trial Material Vendors
+ Experience with global distribution and familiarity with logistics
+ Experience developing and implementing IVRS/IWRS systems
+ Willingness to travel up to 10% to various meetings or client sites, including overnight trips
Preferred Qualifications
+ Master’s degree
+ Analytical Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem
+ Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals
+ Presentation Skills - ability to give professional and concise presentations at internal and external meetings
+ Project Management experience
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics
