Associate Director, Clinical Supply

Position Summary

The Associate Director of Clinical Supply is responsible for the support and management of the clinical drug product supply for the Company's clinical study programs to ensure continuity while maintaining compliance standards and following agreed supply planning processes. Working with a range of departments and internationally based third-party vendors, the Associate Director requires a structured approach to establishing a full support and oversight process with extensive collaboration among internal teams. The position will be required to attend occasional in person meetings in the Parsippany, NJ office with a strong preference to be located on the East Coast.

The Associate Director will report to the Senior Vice President, Chief Technical Officer.

Primary Responsibilities

• Oversees management and communication of clinical drug product supply for the Company's clinical study programs
• Designs, develops, and manages strategies required to support new clinical studies
• Oversees the process to translate inputs from Clinical into a supply strategy and effectively communicate such information
• Develops and maintains clinical supply forecasting and planning tools
• Liaises and manages relationships with external resources as required (e.g. IRT vendors, clinical distributor and packager)
• Liaises with internal departments to understand the forecasted requirements, new clinical studies, and changes to existing studies
• Supports regulatory interactions and submissions with various global regulatory agencies
• Develops and maintains batch records, systems, procedures, and associated documentation in coordination with vendors as well as Quality, Clinical Operations, Manufacturing and Supply Chain, and other functional areas
• Proactively identifies any key supply/demand imbalance, assesses the risk, runs root cause analysis, evaluates options, and proposes solutions
• Ensures corrective/preventive actions are established where required

Competencies

• Solid understanding of the requirements for the production of clinical materials with a CMO
• Well-versed on the intricacies of a global study and the local nuances effecting clinical supply
• Proven ability to work effectively within a multi-disciplinary team environment within a regulated environment
• Extensive knowledge of clinical supply chain principles, including forecasting, planning, logistics, distribution, vendor management, and metrics/reporting
• Comfortable proactively solving issues and working independently
• Strong strategic skills and agility

Experience

• Bachelor's degree in life/physical sciences preferred
• A minimum of 7 years direct experience in the pharmaceutical, biotechnology, or related industry and significant GMP and GDP knowledge
• Extensive experience in the management of multiple global pharmaceutical clinical studies with complex supply chains
• Prior experience and proven knowledge in the use of IRT systems in support of clinical studies, including UAT testing of the initial set-up and subsequent modifications

EEO Statement:

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background.

General Salary Range: $175,000 to $185,000