Director, Clinical Supply Operations

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.