Associate Director of Clinical Supplies

Job Description

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas; (1) Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology, namely Camcevi® and FP-001, targeting specialty markets, and (2) transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.

Please visit www.foreseepharma.com for more information.

• Onsite/Hybrid:At our offices inNewark, DE.
• 100% Remote:Open to candidates anywhere on theUS East Coast (EST), with flexibility for theCentral Time Zone (CST).
• Global Collaboration Note:Because we collaborate closely with our cross-border teams and partners inTaiwan, candidates must be comfortable managing occasional flexible working hours to accommodate international time zone overlap as well as remote US employees
• Base Salary Range:$145,000-$190,000 / year*

* Note on Compensation: Final base salary offers are determined in good faith based on the candidate’s specific geographic location, regional cost-of-living market data, skill set, and years of experience.

Associate Director of Clinical Supplies

The position of Associate Director of Clinical Supplies offers a unique opportunity to support clinical development of Foresee’s NCEs and long-acting injectables. The individual will be responsible for managing all aspects of clinical supplies including budgets and timelines. This individual will report to the Vice President of CMC.

Responsibilities

• Manage CTMs for clinical studies, including planning and forecasting of CTM needs based on study design.
• Evaluate, select, and oversee contract manufacturing, packaging, and labeling operations.
• Develop and manage CTM distribution protocols, interfacing between the CMC and clinical teams to ensure smooth conduct of clinical studies.
• Coordinate import and export of CTMs.
• In partnership with manufacturers and the clinical research team, develop labelling, secondary packaging, and tertiary packaging solutions to ensure clinical trial execution.
• Support drafting and review of INDs and NDAs, and other regulatory documents as needed.Serve as a clinical supply subject matter expert for regulatory inspections.
• Develop clinical supply chain business processes, templates, and SOPs.

Requirements

• Bachelor’s degree or above with a minimum of 7 years of experience in pharmaceutical clinical supply development and management of supplies for clinical trials.
• In‑depth knowledge and experience in pharmaceutical secondary packaging, clinical labeling, and distribution of drug product for clinical trials.
• Experience in setup and execution of IRT systems.
• Effectively communicator on project team meetings.
• Knowledge and understanding of GMP and GXP guidelines and regulatory requirements of CTMs.
• Excellent organizational, problem‑solving and time management skills.
• Fluency in English.
• Self‑motivated, attention to detail, ability to think strategically and work both independently across organizational lines.