Head of Global Product Supply
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Job Summary
Company Description
Rezoluteis a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy RZ358 (ersodetug) is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
Position Description
Overview
A key member ofRezolutesTechnical OperationsLeadership team theHead ofGlobal ProductSupply has the mandate to provide the vision leadership strategy and management skills to build lead and oversee the teams transition from the development and supply of proprietary clinical stage programs to a fully externalized globally enabled and integrated manufacture and supply team supporting direct and partnered particular the Head of Global Product Supply will have oversight over the companys externalized manufacturing and supply chain platform supporting the submission approval launch and supply of ersodetug globally. The position reports to the Head of Operations working daily in collaboration with the Head of Quality Clinical Operations Commercial Leadership Team Regulatory and the RZLT Management Team while acting as a pivotal source of information for the Board of Directors.
Charged with designingdevelopingand implementing the transition oftheexistingclinically oriented functionstoward a robust and reliable manufacturing and supplygroup positioned to support global thisthe organization mustmaintainits agile operational capability whileinstalling the rigidity necessary to meet market demand throughuseof a fully externalized network of this theHead ofGlobal ProductSupplywill partner closely with the Head of Quality todeliver a unified robustmanufactureand supply platform suitable for scale of global supply.
Accountable for the current Plan of Record inclusive of late phase clinical supply supporting two Phase 3 pivotal (global) studies in rare disease.
Works closely withQuality Clinical Operations Regulatory and Finance to sustain a very dynamic clinical supply program continuing toidentifyshortfalls or risks to supply; Leads an agile team tosuccessful outcomes in support ofnear-termCorporate Goals/Strategy and Milestones.
Accountable forallexternalized manufacturing shipping distribution labeling packaging and storage via a global network of qualified vendors; Responsible for the processes utilized by Rezolute to manage and oversee vendor readiness and execution to ensure Right First Time On TimeInFull supply to clinical and commercial supply chains.
Developsstrategytacticsand deliverablesforestablishmentof global supply ofERSODETUGfor multiple indications.
Accountable for identificationandmitigation ofrisks to the supply of product to the clinical and/or global markets; Routinely assess and define risks associated with in the span of control create and implement effective mitigation plans escalatingasappropriate.
Accountablefor identification implementation and maintenance of robustmanufacturinginventorymanagementand supplysystems
Leads a team to collaboratively(Quality MSAT and the Technical Operations Leadership)resolve deviations and investigations enabling on-time reliable supply.
Accountable for and partners with key functions(Commercial OpsMarket AccessPatient Services Finance)toestablishandsustain an S&OP process arriving at supply and demand models COGs and spend to support clinical and commercial supply.
Works cross functionally toidentifyproduct lifecycle needs enabling feasibilitydevelopmentand implementation in concert with product and corporate strategy.
Appliessuitablegovernance structure with external suppliersto drive atopencontemporaneousand clear understanding of conduct of workcostsrisksand deliverables.
Work as part of abroaderTechnical Operations Leadership team striving for openhonest communicationandcollaboration.
Supportsglobalsubmissions in concert withQuality and Regulatory teams.
Build lead manage and develop a best-in-class high-performance team and related support functions. Provide effective leadership to the organization to ensure the development of the business and its people.
Work diligently with the Head of Quality toensure complianceofoperation and procedure supporting the Head of Qualitywith respect toregistrational compliance evaluation and ongoingrelease of drug.
Oversee functional efforts tooptimizeexisting processes scale-upeffortsand solve complex manufacturing issues in a compliant andtimelymanner.
Responsible for assessing and analyzing information resulting in recommendations for long-term manufacturing solutions including new manufacturing sites and facilities that are aligned with the corporate strategy and evolving goals.
Support product launches by ensuring practical andcost-effectivemanufacturing and analytical approaches.
Ensure the management of all financial aspects of supply including budgeting forecasting long-range planning and overall management and accountability of product supply.
Regular interaction with CDMO(s)andMSATsupport teams for continual process improvements.
Work collaboratively with Quality and Regulatory to oversee establishment of development stage and productappropriate specificationsaligned with production capabilities.
Lead development of relationships and contracts for the procurement of high value and cost- effectiveservices and materials for the companys products. Coordinate the selection and oversight ofcomponentvendors and contract manufacturers. Conduct project management and day-to-day interactions with all related research and contract manufacturing operations for clinical products.
Ensure all manufacturing agreements are effectively negotiated to meet thenear and long termneeds ofRezolutein a cost-efficient manner as agreed with legal finance and functional heads.
Review technical documentation and summaries to ensure sound rationale conformance with regulations and existing approvals and challenge whereappropriatethe effectiveness of these documents to deliver on the intended purpose.
Commerciallaunchexperiencerequired
Biologics experiencerequired
20Yrs in progressive Manufacturing and Supply Chain leadership roles within like Lifesciences Start-up/ Biotech organizations; Rare Disease experience preferred
They should havea track recordofestablishinga global commercial product supply chain and having had successful interactions with the regulatory agencies asdemonstratedbytimelyglobal submissionsapprovalsand clinical and commercial supply of pharmaceutical compounds specifically biologics drugs.
Candidate should have comfort in leading through influenceacting with agility leading problem solving and driving toward robust solutions; Communication isacritical strengthdemonstratedat all levels of the organization; Sense of humor and humilityareessential
Position may require/morningeveningand/or weekend commitments as the RZLT team is spread across the US and vendorslocatedoffshore.
Position may require domestic and international travel (up to50%)
Rezolute(RZLT) currentlyanticipatesthe base salary for theHead of Global Product Supplyrole could range from $290000 to $340000and will depend in part on the successful candidates geographical location and their qualifications for the role including education and experience. This position will also be eligible for an annual performance bonusin accordance withthe terms of the applicable plan (depending in part on company and individual performance and at the Companys 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 educationexperienceand geographical location of the selected candidate.
Qualifying employees are eligible toparticipatein 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.
Required Experience:
Director
About Company
Rezolute is a clinical‑stage biopharmaceutical company developing transformative therapies—such as the monoclonal antibody ersodetug (RZ358) in Phase 3 for congenital hyperinsulinism and the oral plasma kallikrein inhibitor RZ402 in Phase 2 for diabetic macular edema—to treat rare met ... View more
