Director, Clinical Supply Chain

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Cambridge, United States QurAlis Full time

ABOUT THE COMPANY 

QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. 

 

QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis’ proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. 

 

Summary of Position  

 

QurAlis is seeking a Director, Clinical Supply to join its Global Supply Chain team. The Director, Clinical Supply is responsible for operational oversight of the planning, packaging, labeling and distribution of Clinical Trial Materials (CTM) and any additional study products to support QurAlis clinical trials. He/she is responsible for oversight and management of clinical supply distribution and associated external vendors. He/she ensures operations and activities are executed in accordance with all internal Standard Operating Procedures (SOPs) and in accordance with all country, state, and federal regulations including Good Manufacturing Practice (GMP) regulations and ICH guidelines.  

 

Primary Job Responsibilities:  

 

  • Partners with Clinical Development Operations to identify demand assumptions, including enrollment rate, number of sites, number of countries, etc. 
  • Schedules and implements labeling, packaging, and quality release operations with CMOs and internally with CMC and Quality departments to ensure continuous clinical supply 
  • Work with Regulatory, QA, Clinical Operations teams and CROs to gather labeling requirements and create, review, and approve Master English Label Text 
  • Work with selected CMOs to generate label proof and label printing to support upcoming labeling runs 
  • Plan and schedule packaging and labeling production runs, review production documents, batch records, specifications, and manage all CMO and internal change control and deviations.  
  • Establish and monitor site and depot level inventory levels, replenish depot and site inventories, manage temperature excursions and proper disposition of products.  
  • Ensures appropriate lead times are planned for the ordering and packaging of clinical trial supplies by monitoring recruitment rates and actual supply needs; ensures continuous re-assessment of supply needs as recruitment and the study progresses by monitoring the use of adequately dated clinical trial supplies at each investigational site 
  • Manages and directs clinical trial supplies return process of vendor by ensuring the reconciliation of CTM and documentation of destruction. 
  • Support selection, design, and implementation of IRT systems, participate in defining user requirements, UAT testing, data integration set up and maintain supply settings for supply management. 
  • Support protocol, IB and pharmacy manual creation, attend and present in investigator meetings as required.  
  • Participates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required; communicates and discusses clinical trial supply timelines, cost and risk limitations 

 

Minimum Qualifications Required:  

 

  • B.S in a scientific, healthcare, or related field. Pharmacy degree preferred but not required.  
  • 10+ years of supply management experience in Pharmaceutical or Biotech industry 
  • Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including manufacturing and distribution vendors, CROs, etc. 
  • Experience in IRT systems 
  • In depth knowledge of Pharmacy requirements for clinical trials including applicable regulatory requirements globally 
  • Ability to work independently and as part of the team in a fast-paced environment  
  • Demonstrated ability to juggle multiple competing priorities and demands 
  • Strong attention to detail 
  • Domestic and international travel may be required occasionally  

  • Clinical Supply Chain, Supply Planner

    Found in: beBee jobs US - 1 week ago

    Cambridge, Massachusetts, United States Proclinical Full time

    Clinical Supply Chain, Supply Planner - Contract - OnsiteProclinical Staffing is seeking a Clinical Supply Chain, Supply Planner to join a leading pharmaceutical company. This is a contract role located in Cambridge, MA.Primary ResponsibilitiesThis role involves coordinating packaging, labeling, shipment, and drug return logistical activities. The successful...

  • Senior Manager, Clinical Supply Chain

    Found in: Talent US C2 - 2 weeks ago

    Cambridge, United States Agios Pharmaceuticals Full time

    Senior Manager, Clinical Supply Chain  Who we are: is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with...

  • Supply Chain Analyst

    4 days ago

    Cambridge, United States Foundation Medicine Full time

    The Supply Chain Analyst is a new role & will be responsible for optimizing and improving the efficiency of the global supply chain process. The role will analyze data related to supply chain processes (demand planning, inventory levels, distribution Supply Chain, Supply Chain Analyst, Global Supply, Analyst, Operations, Microsoft, Healthcare, Transportation

  • Clinical Supply Lead

    1 week ago

    Cambridge, United States The University of Texas MD Anderson Cancer Center Full time

    Job Title: Clinical Supply Lead Job Number: 28557 Location: Cambridge,MA Job Description Reporting to the Clinical Supply Leader, the Clinical Supply Lead (CSL) will be responsible for end-to-end supply chain activities of clinical programs. The CSL will represent the supply chain function on program teams as well as clinical study teams. Responsibilities...

  • Associate Director, Clinical Operations

    1 week ago

    Cambridge, United States Harbinger Health Full time

    Job Description – Associate Director, Clinical Operations Position Summary As an Associate Director, Clinical Operations at Harbinger Health, you will oversee the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams. Reporting to the SVP of Clinical Operations you will drive...

  • Clinical Director

    7 days ago

    Cambridge, United States CareerBuilder Full time

    Job Description Job Description Job Description Director of Clinical Services Department: Clinical Direct Report to: Chief Executive Officer PRIMARY FUNCTION: The Director of Clinical Services is the leader of the Clinical Team who will cover and oversee the clinical department ensuring patient intake, assessments, and quality care is completed and provided...

  • Clinical Director

    1 week ago

    Cambridge, United States Empowered Staffing Full time

    Job Description Job Description Empowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...

  • Clinical Director

    1 week ago

    Cambridge, United States Hickory Recovery Full time

    Job DescriptionJob DescriptionJob Description – Director of Clinical Services Department: ClinicalDirect Report to: Chief Executive OfficerPRIMARY FUNCTION:The Director of Clinical Services is the leader of the Clinical Team who will cover and oversee the clinical department ensuring patient intake, assessments, and quality care is completed and provided...

  • Clinical Director

    5 days ago

    Cambridge, United States Empowered Staffing Full time

    Job DescriptionJob DescriptionEmpowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...

  • Clinical Director

    2 weeks ago

    Cambridge, United States Empowered Staffing Full time

    Job DescriptionJob DescriptionEmpowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...

  • Senior Director, Clinical Data Management

    1 week ago

    Cambridge, United States Editas Medicine Full time

    Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....

  • Senior Clinical Development Director

    1 week ago

    Cambridge, United States Metric Bio Full time

    Our client, a prominent Global Pharmaceutical Company with a rich legacy, dedicated to maintaining the most comprehensive and innovative portfolio in the industry. Renowned for ground-breaking R&D, the company invests significantly in identifying, developing, and delivering innovative solutions to enhance the treatment of diseases and illnesses. Role...

  • Senior Clinical Development Director

    5 days ago

    Cambridge, United States Metric Bio Full time

    Our client, a prominent Global Pharmaceutical Company with a rich legacy, dedicated to maintaining the most comprehensive and innovative portfolio in the industry. Renowned for ground-breaking R&D, the company invests significantly in identifying, developing, and delivering innovative solutions to enhance the treatment of diseases and illnesses. Role...

  • Senior Clinical Development Director

    Found in: Appcast US C2 - 1 week ago

    Cambridge, United States Metric Bio Full time

    Our client, a prominent Global Pharmaceutical Company with a rich legacy, dedicated to maintaining the most comprehensive and innovative portfolio in the industry.Renowned for ground-breaking R&D, the company invests significantly in identifying, developing, and delivering innovative solutions to enhance the treatment of diseases and illnesses.Role...

  • Senior Clinical Development Director

    5 days ago

    Cambridge, United States Metric Bio Full time

    Our client, a prominent Global Pharmaceutical Company with a rich legacy, dedicated to maintaining the most comprehensive and innovative portfolio in the industry.Renowned for ground-breaking R&D, the company invests significantly in identifying, developing, and delivering innovative solutions to enhance the treatment of diseases and illnesses.Role...

  • Senior Clinical Development Director

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Cambridge, United States Metric Bio Full time

    Our client, a prominent Global Pharmaceutical Company with a rich legacy, dedicated to maintaining the most comprehensive and innovative portfolio in the industry.Renowned for ground-breaking R&D, the company invests significantly in identifying, developing, and delivering innovative solutions to enhance the treatment of diseases and illnesses.Role...

  • Senior Director, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

  • Buyer/Planner

    Found in: Appcast US C2 - 16 hours ago

    Cambridge, United States RemX | The Workforce Experts Full time

    Logistics Company: Supply Chain Planner-HYBRIDWe have a fantastic opportunity for a Supply Chain Planner.Our client has a progressive firm and is looking for an ideal candidate:Buying, planning, forecastingExperience with Supply ChainUse of MRPCambridge area, $70-80K +excellent benefits. This is an excellent opportunity to join a terrific team with a great...

  • Buyer/Planner

    Found in: Appcast Linkedin GBL C2 - 11 hours ago

    Cambridge, United States RemX | The Workforce Experts Full time

    Logistics Company: Supply Chain Planner-HYBRIDWe have a fantastic opportunity for a Supply Chain Planner.Our client has a progressive firm and is looking for an ideal candidate:Buying, planning, forecastingExperience with Supply ChainUse of MRPCambridge area, $70-80K +excellent benefits. This is an excellent opportunity to join a terrific team with a great...

  • Sr. Clinical Trial Associate, Clinical Operations

    2 days ago

    Cambridge, United States The Steely Group Full time

    Job DescriptionJob DescriptionReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation,...