Manager/Associate Director of Clinical and Commercial Supplies

About Foresee Pharmaceuticals

Foresee Pharmaceuticals is a fast-growing biotechnology company with a commercial product Camcevi ® (leuprolide) 42 mg, developed with Foresee’s innovative long acting stabilized injectable platform. In addition, Foresee has several novel NCEs in development. Please visit for more information.

The position of Manager / Associate Director of Supply Management offers a unique opportunity to support clinical development and commercialization. The individual will be responsible for managing all aspects of clinical supplies including budgets and timelines for supply of clinical trial materials (CTMs).

The position is also responsible for leading the planning and execution of commercial supply chain activities, including readiness for product launch and commercial secondary packaging and labeling. The individual, acting as a liaison with manufacturing, distribution, marketing, and sales partners, will manage forecasts and placement and shipment of orders of commercial products.

Responsibilities include:

• Manage CTMs for clinical studies, including planning and forecasting of CTM needs based on study design, evaluation/selection/implementation/oversight of contract manufacturing, packaging, and labeling operations, development and management of CTM distribution protocols/agreements, interfacing between the CMC and Clinical teams to ensure smooth conduct of clinical studies, coordination of import and export of CTMs, etc.

• Develop and execute strategies and timelines to ensure a successful commercial product launch, including oversight of service providers, artwork development, process validation, serialization, and forecasting activities.

• Roll out serialization for commercial manufacturing to meet requirements for ePedigree and product traceability. Interface with Product Manufacturers, Serialization Service Providers, Quality Assurance, Information Technology, Operations, etc. to ensure timely implementation.

• In partnership with Product Manufacturers, develop and implement secondary and tertiary packaging solutions as well as shipping and transport qualifications in accordance with applicable regulations.

• Working with Distribution, Marketing and Sales Partners, forecast, order and supply finished drug products to Partners. Manage inventory of finished drug products.

• Develop commercial supply chain business processes, templates, and SOPs. Participate in review of regulatory submissions. Serve as a clinical supply subject matter expert for regulatory inspections. Contribute to INDs, NDAs, and other regulatory documents as needed.

Requirements

• Bachelor’s degree or above with a minimum of 5 years of experience in pharmaceutical supply management of commercial drug products and clinical supplies.

• A successful track record of commercial launch of drug products and management of commercial drug products and CTMs.

• In‐depth knowledge and experience in pharmaceutical secondary packaging, labeling and distribution of drug product, and related regulations.

• Knowledge and hands‐on experience in serialization and its implementation.

• Combination Product Experience is highly desirable, particularly with pre-filled syringes.

• Knowledge and understanding of GMP and GXP guidelines and regulatory requirements of commercial drug products and CTMs.

• Excellent organizational, problem‐solving and time management skills.

• Candidates must be fluent in English. Fluency with French is highly desirable.

• Proficiency with relevant supply chain system, including ERP and BPM system, is highly desirable.

• Self‐motivated, attention to detail, ability to think strategically work both independently and up/down across organizational lines.

• Effective communication and proficiency in Microsoft Office Suite.

Job Types: Full-time, Contract

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• commercial drug product supply management: 10 years (Required)

Language:

• French (Preferred)

Work Location: Hybrid remote in Newark, DE