Director, Product Delivery System Lead - San Mateo, United States - Third Rock Ventures

Description

As a key member of the Commercialization Team, the Director, Product Delivery System Lead will lead the strategy, implementation and operations of CARGO's Product Delivery System team and processes to support the launch of CRG-022.

Reporting to the Senior Director, Commercial Planning & Operations, this critical role will enable a simple and delightful customer experience for CRG-022 across the patient journey from patient identification to product infusion, integrating product, customer and patient support.

Key responsibilities include greenfield product delivery system build, establishment and cross-functional alignment of product delivery processes, system validation, preparation of system-relevant BLA submission needs, review of system and processes within pre-licensing inspection, pre-launch system testing, and live system operation post-launch.

This role will entail close collaborations with and leadership of cross-functional teams, including but not limited to partnership with Commercial Operations, Commercial Planning, Marketing, Market Access, IT, External Manufacturing, Supply Chain, Quality, Legal, and Finance functions.

The role is based in San Carlos, CA but may also be suitable for a Remote arrangement.


WHAT YOU'LL DO AT CARGO THERAPEUTICS

• Lead strategy, implementation and operations of the Product Delivery System team and processes with a cross-functional team of stakeholders across CARGO, including Commercialization, Technical Operations, and G&A
• Generate foundational customer insights to inform product delivery system design and process requirements through a variety of approaches (consultative one-on-one relationships, ad boards, market research, etc.) in collaboration with Commercial Planning
• Lead the greenfield build of CARGO's Product Delivery System for CRG-022 launch that incorporating the hospital's view of patient registration and product ordering, case manager's view of product ordering and support, chain-of-identity (COI), chain of custody (COC), courier shipping and tracking, patient and caregiver support, hospital reimbursement support, 3rd party logistics, and financial transactions
• Integrate CARGO's Product Delivery System with multiple internal CARGO systems and critical external partners, including quality/manufacturing/CMOs, couriers, 3PL, and other commercialization operations systems to enable KPI tracking and consistent master data across the company
• Ensure a functional and validated product delivery system platform supporting the End to End Product Journey required for BLA filing and pre-licensing inspection
• Implement a clear framework of goals and tactics that result in best-of-breed product delivery team, system, and processes
• Ensure strategic alignment with Executive Team through regular Steering Committee check-ins
• Establish and maintain the operational infrastructure and processes for supporting the product delivery needs of the U.S. Commercial Organization and subsequent geographies and/or partnerships as required
• Lead with judicious fiscal planning predicated on CRG-022 development phases and milestones
• Prioritize a data driven approach to system and processes to enable appropriate and compliant visibility into the business

THE RIGHT STUFF:
Required Experience & Qualifications

• BS required; advanced degree desired (MBA, PhD, MS in scientific field/analytical field)
• 8+ years of experience in building and supporting commercial operations systems, SFDC platform and data warehouse production environments
• Proven deep experience in transplant/cell therapy
• Greenfield build of product delivery system for cell or gene therapies preferred
• Demonstrated expertise in complex structured problem solving, process mapping, and operational design
• Ability to actively anticipate, track and plan for risks, issues, dependencies, resourcing, and contingencies
• Experience working with all levels of management and consulting with key business stakeholders and an ability to influence for greater outcomes
• Strong executive presence and team player
• Attention to detail and the ability to work individually, within a multidisciplinary team, as well as with external partners and vendors
• Existing knowledge of bone marrow transplant and/or cell therapy external and internal processes
• Demonstrated experience learning complex business processes and ability to operate in a complex cross functional environment, including interacting with external customers
• Demonstrated cross-functional leadership and influence without authority
• Ability to proactively identify problems and develop solutions
• Exquisite organizational and follow up skills
• Proven ability to drive results towards a set objective
• Strategic mindset
• Conflict management & resolution; exceptional communication skills
• Experience in program/project management of strategic initiatives in a healthcare setting
• Familiarity/experience working with Transplant Centers

PAY RANGE
The combined pay range for this role is $175,000 - $240,000.

Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients.

CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply.

CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.

CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies.

Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion.

CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products.

For more information, please visit the CARGO Therapeutics website at https:
//cargo-Join us to help make a difference

EEO & EMPLOYMENT ELIGIBILITY

CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company.

We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.

CARGO Therapeutics, Inc.

also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.

This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote.

If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

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