Head of Global Product Supply

Company Description

• Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance
• Rezolute has initiated a global Phase 3 trial in for RZ358 as a treatment for congenital hyperinsulinism (cHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas
• Rezolute will be initiating a global Phase 3 trial for RZ358 as a treatment for tumor hyperinsulinism (tHI), and ultra-rare co-morbidity of insulinomas and some other non-islet cell tumors, characterized by excessive production of insulin or IGF-2 by cancerous tumors.
• Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher for the cHI program; and will file for breakthrough status on the tHI program.
• More information can be found at

Position Description

Overview

A key member of Rezolute’s Technical Operations Leadership team, the Head of Global Product Supply has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee the team’s 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 markets. In particular, the Head of Global Product Supply will have oversight over the company’s externalized manufacturing and supply chain platform, supporting the submission, approval, launch and supply of RZ358, globally. The position reports to the Head of Technical Operations, working daily in collaboration with the Head of Quality, Clinical Operations, New Product Planning, Regulatory and the RZLT Management Team, while acting as a pivotal source of information for the Board of Directors.

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. In this, 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; Will rebuild 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 RZ358 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 (New Product Planning, 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.

Areas of specific responsibility include:

• 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 to ensure compliance of operation and procedure, supporting the Head of Quality with respect to registrational compliance evaluation, and ongoing release of drug.
• Oversee functional efforts to optimize existing processes, scale-up efforts and solve complex manufacturing issues in a compliant and timely manner.
• 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 and cost-effective manufacturing 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) and MSAT support teams for continual process improvements.
• Work collaboratively with Quality and Regulatory to oversee establishment of development stage and product appropriate specifications aligned with production capabilities.
• Lead development of relationships and contracts for the procurement of high value and cost- effective services and materials for the company's products. Coordinate the selection and oversight of component vendors 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 the near and long term needs of Rezolute in 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 where appropriate the effectiveness of these documents to deliver on the intended purpose.

Candidate Profile

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

• B.S. is required
• 15 Yrs+ in progressive Manufacturing and Supply Chain leadership roles within like Lifesciences Start-up/ Biotech organizations; Rare Disease experience preferred; Commercial launch experience preferred; Biologics process and manufacture 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
• Position may require /morning, evening and/or weekend commitments as the RZLT team is spread across the US, and vendors located offshore.
• Position may require domestic and international travel (up to 20%)