Location: Redwood City, CA Onsite

Position Description

Overview

The Senior Director, Global Supply Chain will be responsible for establishing and leading the Supply Chain and Distribution organization at Rezolute. As a key member of the Global Product Supply Leadership Team, the individual will be responsible for the establishment of best-in-class systems and processes enabling the global launch and continuous supply of Rezolute products throughout the US and EU.

The individual will work amongst a team of CMC experts in a matrix organization, capitalizing on each other’s expertise in a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics.

Reporting to the Vice President, Global Product Supply, this role is 100% office based at Rezolute’s Redwood City office.

Responsibilities Include:

• Leading the Clinical Supply Chain function at Rezolute, managing global clinical supply from britestock through depot to global clinical sites to ensure the continuous supply of quality product to the patients we serve.
• Building and leading a world class Commercial Supply Chain organization at Rezolute, identifying key additions as required.
• Partnering with Rezolute Quality to ensure a “Quality First” mindset throughout our Supply Chain
• Partnering with colleagues in Quality and Accounting, responsible for the establishment and maintenance of an internal GMP and SOX compliant inventory management system.
• Responsible for the execution of Rezolute’s Transport Validation Master Plan.
• Establish a Logistics and Global Trade Compliance function at Rezolute, enabling the controlled and compliant movement of Rezolute products across international borders through validated means.
• Implementation of a global serialization platform ensuring full compliance with global track and trace regulations.
• Establish a commercial distribution network enabling rapid patient access to our products.
• Advanced operational support and technical communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant inspections
• Author relevant sections of regulatory submissions and response materials; interface with regulators on all components of regulatory filings
• Vendor technical / capability assessment and support of Vendor (Supplier) Qualification Process

Candidate Profile

Qualifications/Requirements – We are looking for a candidate with:

• Experience managing global clinical supply for multiple Phase 3 studies.
• Advanced degree in a related field with at least 10 – 12 years’ experience in a highly regulated pharmaceutical Supply Chain role.

• Experience of transitioning Supply Chain teams from Clinical to Commercial launch.
• Experience leading the design and implementation of GMP and SOX compliant electronic inventory management systems. NetSuite experience preferred.
• Experience leading the implementation of EPCIS systems enabling compliance with global serialization and track and trace regulations. Tracelink experience preferred.
• Experience leading the design and implementation of US and EU distribution networks, including final mile delivery, enabling the launch and continuous supply of temperature regulated pharmaceutical products.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices and global regulations
• Must be willing to travel domestically and internationally as required (up to 10%)
• Ability to work in a highly collaborative, virtual, entrepreneurial environment leveraging external collaborations to accomplish individual and team goals.

Preferred Experience, Special Skills and Knowledge – We are looking for a candidate that has:

• Strong leadership skills and ability to effectively communicate up, down and across the organization.
• Ability to effectively prioritize and deliver high-quality results on tight timelines.
• Excellent written, verbal communication and presentation skills.
• Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues.
• Act with HONOR:  Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect

To Apply

Interested and qualified candidates should send a resume to recruiting@rezolutebio.com to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Senior Director, Global Supply Chain role could range from $220,000 to $250,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.