Senior Manager, Clinical Supply

Vaxcyte; San Carlos (CA); Hybrid; USD 158,000 - 185,000; Full time

Job summary

Vaxcyte in San Carlos, CA is seeking a Sr. Manager, Clinical Supply to lead clinical demand and supply planning, and to plan and execute clinical packaging runs. This role ensures trials have sufficient vaccine and comparator supply to start and complete without interruptions.

You will collaborate across Clinical Operations, QA, Regulatory, Supply Chain, and Process Development, manage labeling, batch genealogy, and cold-chain logistics, and track inventory at depots and sites.

Qualifications

• Bachelor’s degree in Life Sciences, Supply Chain, or Logistics; advanced degrees are a plus.
• 9+ years’ experience working in Clinical Supply Management.
• Experience with Blinded personnel and clinical supplies.
• Experience with vaccine trials highly desired.
• Experience with Veeva Vault highly desired.
• Experience with global regulatory labelling requirements for clinical trials.
• Working knowledge of current GMP.
• Experience with Cold Chain packaging, and logistics.
• Experience with Reverse Distribution, Accountability, and Destruction.
• Experience leading Cross-Functional teams.
• Good verbal and written communication skills.

Responsibilities

• Determine vaccine & comparator demand based on protocol, # of sites, shelf life, & risk.
• Translate demand plan into a supply plan (#, timing volume of packaging runs).
• Work closely with clinical secondary packaging sites, central and sub-depots and key stakeholders in Clinical Operations, Regulatory, Quality, Supply Chain, & Process Development to develop detailed project plan for each packaging run.
• Scenario planning based on potential different protocol designs or supply chain risks.
• Develop detailed project plan for each packaging run.
• Manage execution of packaging plan, and resolve / elevate issues as needed.
• Manage Clinically Labelled Drug Product label text/proof development, and Approval following regulatory guidelines, and in Veeva.
• Batch records pre-, and post-production review, and approval in Veeva.
• Collaborate with QA on central depot document management in Veeva.
• Partner with Clinical on IRT selection, implementation, and UAT.
• Manage cold-chain logistics for Clinically Labelled Drug Product.
• Inventory management for depots, and clinical sites.
• Monitor trial execution vs plan and drug shelf life and make adjustments to supply plan as needed to maintain supply continuity.
• Maintain Clinical supply dashboard and metrics.
• Maintain Batch Genealogy database.
• Resolve temperature excursions in storage depots, during shipping, and at clinical sites.
• Perform inventory reconciliation at end of trial.
• Ensure excess packaged inventory at end of trial is disposed of in a compliant manner.

Skills

Cross-Functional Leadership

Verbal & Written Communication

Supply Chain Management

Regulatory Awareness

Education

Bachelor’s degree in Life Sciences, Supply Chain, or Logistics

Tools

Veeva Vault

Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.


• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.


• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.


• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

Vaxcyte is seeking a Sr. Manager, Clinical Supply, to lead clinical demand and supply planning, along with the planning and execution of clinical packaging runs. This role will be instrumental to ensure that our trials have sufficient vaccine and comparator supply to start as planned and continue to completion without any interruptions.

Essential Functions:

• Determine vaccine & comparator demand based on protocol, # of sites, shelf life, & risk.


• Translate demand plan into a supply plan (#, timing volume of packaging runs).


• Work closely with clinical secondary packaging sites, central and sub-depots and key stakeholders in Clinical Operations, Regulatory, Quality, Supply Chain, & Process Development to develop detailed project plan for each packaging run.


• Scenario planning based on potential different protocol designs or supply chain risks.


• Develop detailed project plan for each packaging run.


• Manage execution of packaging plan, and resolve / elevate issues as needed.


• Manage Clinically Labelled Drug Product label text/proof development, and Approval following regulatory guidelines, and in Veeva.


• Batch records pre-, and post-production review, and approval in Veeva.


• Collaborate with QA on central depot document management in Veeva.


• Partner with Clinical on IRT selection, implementation, and UAT.


• Manage cold-chain logistics for Clinically Labelled Drug Product.


• Inventory management for depots, and clinical sites.


• Monitor trial execution vs plan and drug shelf life and make adjustments to supply plan as needed to maintain supply continuity.


• Maintain Clinical supply dashboard and metrics.


• Maintain Batch Genealogy database.


• Resolve temperature excursions in storage depots, during shipping, and at clinical sites.


• Perform inventory reconciliation at end of trial.


• Ensure excess packaged inventory at end of trial is disposed of in a compliant manner.

Requirements:

Bachelor’s degree in Life Sciences, Supply Chain, or Logistics; advanced degrees are a plus. 9+ years’ experience working in Clinical Supply Management. Other combinations of education and/or experience may be considered.

• Experience working with Blinded personnel and clinical supplies.


• Experience with vaccine trials highly desired.


• Experience with Veeva Vault highly desired.


• Experience with global regulatory labelling requirements for clinical trials.


• Working knowledge of current GMP.


• Experience with Cold Chain packaging, and logistics.


• Experience with Reverse Distribution, Accountability, and Destruction.


• Experience leading Cross-Functional teams.


• Good verbal and written communication skills.

Reports to: Director, Clinical Supplies

Location: San Carlos, CA

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):

Hybrid (minimum of 2-3 days per week onsite)

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $158,000 - $185,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.