- DNA interactions.
-
Supply Chain Operations Director
2 days ago
Philips Cambridge, United States Full timeJob Title · Supply Chain Operations Director · Job Description · Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of o ...
-
Director, Clinical Supply Operations
3 weeks ago
FogPharma Cambridge, United StatesJob Description · Job DescriptionWhy Join Us? · FogPharma is pioneering the discovery, development, and commercialization of HeliconTM peptides, an exciting new drug modality that uniquely combines the cell-permeability of traditional small molecule drugs with the specificity, br ...
-
Supply Chain Operations Director
3 weeks ago
Philips Iberica SAU Cambridge, United StatesJob Title Supply Chain Operations Director Job Description · Supply Chain Operations Director has responsibility for operations at key contract manufacturing partners in the S&RC (Sleep & Respiratory Care devices) supply chain, including accountability for all aspects of operati ...
-
Director, Clinical Supply Operations
3 weeks ago
FogPharma Cambridge, United StatesWhy Join Us? · FogPharma is pioneering the discovery, development, and commercialization of HeliconTM peptides, an exciting new drug modality that uniquely combines the cell-permeability of traditional small molecule drugs with the specificity, broad target accessibility and dis ...
-
Director, Clinical Supply Operations
3 weeks ago
FogPharma Cambridge, United StatesWhy Join Us?FogPharma is pioneering the discovery, development, and commercialization of HeliconTM peptides, an exciting new drug modality that uniquely combines the cell-permeability of traditional small molecule drugs with the specificity, broad target accessibility and discove ...
-
Director, Clinical Supply Operations
4 days ago
Fog pharma Cambridge, MA, United StatesWhy 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 i ...
-
Director, Clinical Supply Operations
3 weeks ago
FogPharma Cambridge, United StatesJob Description · Job DescriptionWhy Join Us? · FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Thr ...
-
Vice President of Operations, Supply Chain
2 days ago
WiTricity Watertown, United StatesVice President of Operations, Supply Chain & Logistics · Bachelor's degree in Engineering, Supply Chain Management, Operations Management, or related field · Responsibilities · Reporting to the CEO, this role will have responsibility for successful delivery of quality products ...
-
Operations Support Specialist Supply Chain
3 weeks ago
Mass General Brigham Somerville, United StatesRole Overview: · Mass General Brigham Supply Chain, a department within Mass General Brigham Finance, is committed to managing a progressive supply chain continuum. Driven by accountability, ethics, and fiduciary responsibility, we support the Mass General Brigham mission throug ...
-
Operations Support Specialist Supply Chain
3 weeks ago
Partners , Inc. Somerville, United States: · Role Overview: · Mass General Brigham Supply Chain, a department within Mass General Brigham Finance, is committed to managing a progressive supply chain continuum. Driven by accountability, ethics, and fiduciary responsibility, we support the Mass General Brigham mission th ...
-
Surgical Supply Operations Supervisor
3 days ago
Brigham & Women's Hospital(BWH) Boston, United States**Surgical Supply Operations Supervisor - Days** · **General Summary**: · ***Under the guidance of the Inventory Operations Manager, this position is responsible or the shift operations regarding control, flow, purchasing, receiving, distribution, case cart operations, and accura ...
-
Senior Supply Chain Operations Manager
2 weeks ago
Boston Metal Woburn, United StatesBoston Metal is at the forefront of transforming the primary metals production industry through innovative extractive metallurgy technologies. These advancements not only significantly reduce costs but also have a profound positive impact on the environment. In line with our grow ...
-
Vice President of Operations, Supply Chain
5 days ago
WiTricity Watertown, United StatesVice President of Operations, Supply Chain & Logistics · Bachelor's degree in Engineering, Supply Chain Management, Operations Management, or related field · Responsibilities · Reporting to the CEO, this role will have responsibility for successful delivery of quality products o ...
-
Supply Chain/Operations Analyst
2 days ago
Teradyne North Reading, United StatesIn the Business Analyst role, you will support the North Reading and Philippines locations that produces Mil/Aero and circuit board test equipment. You will be a part of a team that will interface with production, quality and manufacturing teams in North Reading and Cebu. As a pa ...
-
Supply Chain Operations Analyst
2 weeks ago
Dr. Schär Swedesboro, United StatesDr. Schar USA is a gluten-free manufacturing company, located in Swedesboro, NJ that is looking to add a Supply Chain Operations Analyst to our team. This role is centered around finished goods inventory control from production to distribution. This individual should be able to w ...
-
Perioperative Registered Nurse, Operating Room
3 weeks ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Night (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Perioperative Registered Nurse, Operating RoomJob ...
-
Internship in Business Development
1 week ago
Aurora Ventures Cambridge City, United States InternshipSHIPAbout the Company · We are a dynamic and fast-growing company in the field of renewable energy, with the belief that there is an abundance of energy in our environment. We harness this energy - and we are excited to have your support in doing so. · Since our founding in the envir ...
-
Branch Manager of Building Materials Trade
1 week ago
Stellar Enterprises Cambridge, United StatesBAUEN+LEBEN is the strong partner for professionals and private customers when it comes to new construction, renovation and modernization. The BAUEN+LEBEN group includes over 80 medium-sized and independent building suppliers in a total of nine federal states. · Included with us ...
-
Analyst, Supply Chain Operations Research
2 weeks ago
Staples Framingham, United StatesJob DescriptionStaples is business to business. You're what binds us together.When joining our Supply Chain team, you can feel right away that people are at the heart of what we do. You'll be surrounded by a team who is looking to make an impact on our customers, our community, a ...
-
Aurora Technologies New Boston, United StatesFrom the region - for the region: As a municipal supply and service company, the New Boston City Utilities are deeply rooted in the Warendorf district. They reliably supply citizens with electricity, natural gas, heat, and drinking water and operate an attractive pool landscape. ...
Director, Clinical Supply Operations - Cambridge, United States - FogPharma
Description
Why Join Us?FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and proteinFOG-001, the company's first-in-class TCF-blocking ?-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 OperationsManage 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.
&v=024){kind=logo}
