What are the responsibilities and job description for the Clinical Supply Manager position at Madrigal Pharmaceuticals?
About Madrigal:
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
Clinical Supply Manager
We are seeking a detail-oriented and experienced Clinical Supply Manager to oversee the planning, coordination, and distribution of clinical trial materials. The Clinical Supply Manager will ensure that investigational medicinal products (IMP) and other clinical supplies are delivered on time, in compliance with regulatory requirements, and aligned with study needs.
Position Responsibilities:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
Clinical Supply Manager
We are seeking a detail-oriented and experienced Clinical Supply Manager to oversee the planning, coordination, and distribution of clinical trial materials. The Clinical Supply Manager will ensure that investigational medicinal products (IMP) and other clinical supplies are delivered on time, in compliance with regulatory requirements, and aligned with study needs.
Position Responsibilities:
- Develop and execute clinical supply plans for multiple studies, ensuring timely availability of investigational medicinal products (IMP) and materials
- Forecast supply needs and manage inventory levels to prevent shortages or overages
- Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance to align supply strategies with trial requirements
- Work with packaging vendors to coordinate production, labeling, packaging, and distribution of clinical trial materials
- Monitor shipment logistics, including temperature-controlled storage and transport, ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
- Maintain accurate documentation of supply chain activities, ensuring adherence to regulatory guidelines (e.g., FDA, EMA, ICH, GCP)
- Support Investigational Medicinal Product (IMP) release, reconciliation, and destruction processes
- Identify and mitigate risks associated with supply chain disruptions
- Optimize supply chain processes by implementing best practices and continuous improvement initiatives
- Bachelor's degree in a related field (e.g., Supply Chain Management, Life Sciences, Pharmacy, or Business)
- 5 years of experience in clinical supply chain management within the pharmaceutical or biotechnology industry, familiarity with global clinical trial regulations and international supply chain challenges
- Strong understanding of clinical trial operations, regulatory requirements, and GMP/GCP/GDP guidelines
- Experience working with clinical packaging, labeling, and distribution vendors
- Proficiency in supply forecasting and inventory management tools
- Excellent project management and problem-solving skills
- Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders
- Ability to work in a fast-paced environment with shifting priorities
- Experience with Interactive Response Technology (IRT) for clinical supply management
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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