Current jobs related to Director, Clinical Supply Operations - Cambridge - FogPharma
-
Director Clinical Supply Chain
2 months ago
Cambridge, United States QurAlis Full timeTitle: Clinical Supply Chain (Associate Director/Director) ABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis...
-
Director Clinical Supply Chain
4 weeks ago
cambridge, United States QurAlis Full timeTitle: Clinical Supply Chain (Associate Director/Director) ABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis...
-
Clinical Supply Chain Director
3 weeks ago
Cambridge, Massachusetts, United States QurAlis Full timeAbout QurAlisWe are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.Job SummaryWe are seeking an experienced and highly motivated individual to join our...
-
Director, Supply Chain Planning and Operations
2 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeJob SummaryVericel Corporation, a leading biopharmaceutical company, is seeking a highly experienced Supply Chain Director to join our team. As a key member of our Operations Management team, you will be responsible for designing, implementing, and overseeing an industry-leading end-to-end supply chain planning and external partnerships strategy for our...
-
Clinical Supply Operations Manager
3 days ago
Cambridge, Massachusetts, United States Biogen Full timeAbout This RoleThe Global Clinical Supply Chain (GCSC) at Biogen is seeking a Clinical Supply Operations Manager to ensure high levels of compliance and effectiveness in its operations. This role will be responsible for managing Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.This person will build positive...
-
Supply Chain Director
2 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeJob Title: Director, Planning and External Supply ChainVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a top-performing supply chain professional to join its commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics.Job SummaryThe...
-
Cambridge, Massachusetts, United States Vericel® Corporation Full timeJob Title: Director, Planning and External Supply ChainVericel Corporation, a leading innovator in advanced therapies for sports medicine and severe burn care, seeks a seasoned supply chain professional to join our team. As a Director, Planning and External Supply Chain, you will play a critical role in designing, implementing, and overseeing our end-to-end...
-
Director of Supply Chain Planning
5 days ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeJob Title: Director, Planning and External Supply ChainVericel Corporation, a leading innovator in advanced therapies for the sports medicine and severe burn care markets, is seeking a seasoned supply chain professional to join our team. As a Director, Planning and External Supply Chain, you will play a critical role in designing, implementing, and...
-
Clinical Supply Operations Manager
3 days ago
Cambridge, Massachusetts, United States Biogen Full timeAbout This RoleThe Global Clinical Supply Chain (GCSC) at Biogen is seeking a Clinical Supply Operations Manager to ensure high levels of compliance and effectiveness in its operations. This role will be responsible for managing Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.This person will build positive...
-
Clinical Supply Operations Manager
4 weeks ago
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout This RoleThe Global Clinical Supply Chain (GCSC) is looking to hire a Clinical Supply Operations Manager to assure a high level of compliance and effectiveness for GCSCs operations. GCSC’s goal is to deliver medicines across the world to all patients enrolled in Biogen’s Clinical Studies. The...
-
Director of Plant Operations and Maintenance
4 weeks ago
Cambridge, Vermont, United States Clinical Management Consultants Full timeDirector of Plant Operations and MaintenanceClinical Management Consultants is seeking an experienced leader to oversee the facilities and operations of our critical access hospital in northern Vermont.We are looking for a dedicated professional to join our team and contribute to the success of our organization.Key Responsibilities:Oversee the maintenance,...
-
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob SummaryAkebia Therapeutics is seeking a highly experienced and skilled Director, Commercial Supply Chain to oversee and manage all aspects of our commercial supply chain operations. This role is crucial in ensuring the efficient and effective delivery of our products to market, maintaining high standards of quality and compliance, and driving continuous...
-
Clinical Supply Operations Manager
6 days ago
Cambridge, Massachusetts, United States Biogen Full timeAbout This RoleWe are seeking a highly skilled Clinical Supply Operations Manager to join our Global Clinical Supply Chain team. As a key member of our team, you will be responsible for ensuring the effective management of clinical trial materials and the delivery of high-quality medicines to patients worldwide.The ideal candidate will have a strong...
-
Hospital Facilities Director
4 weeks ago
Cambridge, Vermont, United States Clinical Management Consultants Full timeDirector of Plant Operations and MaintenanceClinical Management Consultants is seeking an experienced leader to oversee the facilities and operations of our critical access hospital in northern Vermont.We are looking for a dedicated professional to join our team and contribute to the success of our organization.Key Responsibilities:Oversee the maintenance,...
-
Clinical Operations Director
2 weeks ago
Cambridge, Massachusetts, United States True North Consulting Full timeJob Title: Associate Director, Clinical Monitoring OversightTrue North Consulting is seeking a highly experienced and skilled Associate Director to lead our clinical monitoring oversight efforts. As a key member of our clinical operations team, you will be responsible for overseeing the implementation of a global sponsor oversight monitoring program,...
-
Sr. Manager, Clinical Supplies Systems
1 month ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Senior Manager, Clinical Supplies Systems to oversee and manage IRT systems for Modernas growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations and leadership capacity) to ensure Modernas clinical portfolio aligns with internal stakeholders and timelines from business....
-
Manager, Clinical Supplies Systems
1 month ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Modernas growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations) to ensure Modernas clinical portfolio aligns with internal stakeholders and timelines from business. This position will work...
-
Director, Clinical Operations
4 weeks ago
Cambridge, United States Foghorn Therapeutics Full timeJob DescriptionJob DescriptionOur Culture: Why work with us?At Foghorn Therapeutics, we believe in “People First, Mission Always.” We put “People First” because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics...
-
Manager of Clinical Supply Chain Operations
1 month ago
Cambridge, Massachusetts, United States Biogen Full timePosition OverviewThe Global Clinical Supply Chain (GCSC) is seeking a skilled Manager of Clinical Supply Chain Operations to ensure a high standard of compliance and efficiency in GCSC's processes. The primary objective of GCSC is to provide essential medications globally to all participants in Biogen's Clinical Studies. This role encompasses...
-
Associate Director of Clinical Data Operations
18 hours ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: Associate Director of Clinical Data OperationsIntegrated Resources, Inc (IRI) is seeking an experienced Associate Director of Clinical Data Operations to join our team. As a key member of our Clinical Data Operations team, you will be responsible for overseeing the operational aspects of clinical trials, including data monitoring, vendor...
Director, Clinical Supply Operations
4 months ago
Why Join Us?
FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.
FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.
What's the opportunity?
In this role, you will help us develop a new drug modality for cancer and other diseases with unmet medical needs by working directly with Research and Development (R&D) functions to execute clinical trials.
The Director, Clinical Supply Operations will serve as the liaison with multiple departments and vendors to provide implementation and oversight for the planning, labeling, and distribution of clinical trial materials. This role will provide leadership and direction to CDMOs and other vendors. Additionally, this leader will provide Clinical Supply Operations expertise in cross-functional meetings and to corporate SOPs and initiatives.
You will work in a nimble, dynamic, matrix environment with Clinical Trial Teams (CTT), investigative site staff and a variety of vendors and consultants to ensure trial delivery in accordance with SOPs, applicable regulations and guidelines.
Director, Clinical Supply Operations
- Manage global supply planning strategy, creating drug forecasts, and designing packaging configurations based on study and program level needs to optimize overall drug inventory.
- Review product life cycle strategy on an ongoing basis to proactively manage risks to clinical trial supply availability and continuity (includes product stability plans, process changes, IND/IMPD submissions and updates).
- Oversee the set-up and activation of systems to monitor and track clinical supply inventories at the depot, warehouse, and site level for studies; provide inventory and logistics management of IP, adjusting drug distribution plans with coordination of packaging and labeling at Contract Packaging Vendors.
- Collaborate with cross-functional stakeholders to select, establish contracts with and oversee external partners and suppliers, ensuring timely release and availability of clinical supplies.
- Build a robust end-to-end supply logistics business processes including materials management, inventory management, logistics/distribution, product valuation, and trade compliance.
- Create operating policies and procedures to provide comprehensive coordination of complex supply chain operations, inventories, and materials while ensuring compliance to regulations and guidelines.
- Support cross-functional team in financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials.
- Represent clinical supplies function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
- Contribute to and review the preparation of clinical protocols, INDs, IMPDs, and other related Regulatory documents.
- Oversee creation of clinical trial pharmacy manuals, packaging methods, batch records, shipping documents, and destruction certification.
- Coordinate the origination, proofing and translation of clinical study labels, ensuring compliance with applicable regulations.
- Establish governance and oversight of all clinical supply vendors including, but not limited to, IRT/RTSM, labelling, distribution, storage, transfer and destruction.
- Liaise with vendors and collaborators to source additional supplies as needed, i.e. administration supplies, concomitant/comparator medications, etc.
- Program/trial budget management, reporting and forecasting activities.
- Maintain knowledge of external environment to ensure innovations are considered and/or incorporated into clinical trial delivery strategy.
What you'll need to be successful:
- S./B.A. in life science or related field; MS/MA highly beneficial.
- 13+ years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development.
- Experience in biotechnology, pharmaceutical and/or CRO industry.
- Phase 1-3 global supply chain management experience, including first in human studies, preferably in Oncology.
- Direct experience overseeing global third-party contract clinical supply operations vendors.
- Experience in creation of Supply Planning tools is preferred.
- Direct line management experience.
- Solid understanding of Pharmaceutical Development, Quality Assurance, and Regulatory Affairs as relates to supply chain management (domestic and international).
- In depth knowledge of clinical supply planning, manufacturing, packaging, labeling, and distribution logistics.
- Ability to advised study teams and coordinate across multiple disciplines/development programs to achieve study goals and timelines.
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
- Solid attention to detail and excellent organizational skills.
- Strong interpersonal and communication skills (both written and oral).
- Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization.
- Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills).
- Creative problem-solving skills.
- Self-motivated and adaptable in a dynamic, nimble, start-up environment.
- Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT and EDC platforms.
- Ability to work on-site or remotely and attend in-person meetings.
As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
