Primary Responsibilities:

Review and Interpretation of a clinical protocol or study overview:

Review and provide feedback during the development of the clinical protocol.

Evaluate total demand and translation of total demand into a demand forecast.

Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.

Regularly reviews and updates inventories and supply plan against Clinical forecasts including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.

Tracks expired materials and issues orders for retrieval or disposal.

Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.

Challenges current processes, practices and strategies

Provides innovative solutions to complex issues and consistently evaluates opportunities for improvement.

Investigates and resolves issues regarding inventory, shipments and returns.

Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.

Provides and supports budgets for existing and newly planned Projects.

Supports CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary

Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines

Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs

Works collaboratively with Vendors to optimize relationships and build confidence.

Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness

Reconciles and approves invoices

Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects as assigned

Education/Experience/Skills

Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years of experience in pharmaceutical development focused on clinical trial materials

The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products

Proven project management skills

Develops team building and training of staff to support Team skills and enhance operational effectiveness

Ability to handle multiple projects/staff simultaneously

Excellent understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11)

Excellent understanding and working knowledge of IRT system build-up and user testing

Experienced in negotiating skills with customers and suppliers

Hands on training and experience in clinical trial methodology and Good Clinical Practice

Excellent organizational and documentation skills

Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams

Excellent written and verbal communication skills

Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization

Skilled at creating a cooperative team environment

Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to twenty pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-SW1 #LI-HYBRID In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. Salary Range $177,000 — $221,700 USD What we offer US-based Employees:

Competitive base, bonus, new hire and ongoing equity packages

Medical, dental, and vision insurance

Employer-paid life, disability, business travel and EAP coverage

401(k) Plan with a fully vested company match 1:1 up to 5%

Employee Stock Purchase Plan with a 2-year purchase price lock-in

15+ vacation days

13 -15 paid holidays, including office closure between December 24th and January 1st

10 days of paid sick time

Paid parental leave benefit

Tuition assistance