Head of Global Product Supply

Principle Duties And Responsibilities Include

• Charged with designing, developing and implementing the transition of the existing, clinically oriented functions toward a robust and reliable manufacturing and supply group, positioned to support global markets.
• In this, the organization must maintain its agile operational capability while installing the rigidity necessary to meet market demand through use of a fully externalized network of vendors.
• The Head of Global Product Supply will partner closely with the Head of Quality to deliver a unified, robust manufacture and 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.
• Provides oversight, leadership and management as needed to meet program milestones, manufacturing of drug substance, drug product and finished drug product.
• In parallel provides executive leadership, management to guidance to addresses risks associated with global supply of Investigational Product to depots, subdepots and clinical sites through an existing Clinical Supply Team.
• Works to continuously develop the manufacturing and supply chain operation and teams to ensure robustness and reliability of supply;
• Rebuilds the clinical supply chain as a priority through hiring or key resource, definition and deployment of process and procedure, and robust management and monitoring of daily execution.
• Works closely with Quality, Clinical Operations, Regulatory and Finance to sustain a very dynamic clinical supply program, continuing to identify shortfalls or risks to supply;
• Leads an agile team to successful outcomes in support of near-term Corporate Goals/Strategy and Milestones.
• Accountable for all externalized 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 Time In Full supply to clinical and commercial supply chains.
• Develops strategy, tactics and deliverables for establishment of global supply of ERSODETUG for multiple indications.
• Accountable for identification and mitigation of risks 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, escalating as appropriate.
• Accountable for identification, implementation and maintenance of robust manufacturing, inventory management and supply systems;
• 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 Ops, Market Access, Patient Services, Finance) to establish and sustain an S&OP process, arriving at supply and demand models, COGs, and spend, to support clinical and commercial supply.
• Works cross functionally to identify product lifecycle needs, enabling feasibility, development and implementation in concert with product and corporate strategy.
• Applies suitable governance structure with external suppliers to drive at open, contemporaneous and clear understanding of conduct of work, costs, risks and deliverables.
• Work as part of a broader Technical Operations Leadership team, striving for open, honest communication, and collaboration.
• Supports global submissions in concert with Quality and Regulatory teams.

Qualifications/Requirements

• We Are Seeking a Candidate With B.S.
• Required Commercial launch experience
• Required Biologics experience
• 20 Yrs+ in progressive Manufacturing and Supply Chain leadership roles within like Lifesciences Start-up/ Biotech organizations;
• Rare Disease experience preferred
• They should have a track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies, as demonstrated by timely global submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs.
• Candidate should have comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions;
• Communication is a critical strength, demonstrated at all levels of the organization;
• Sense of humor and humility are essential