Program Manager, Diagnostics New Product Development

1 month ago

Charlottesville, United States Plus Therapeutics, Inc. Full time

Program Manager, Diagnostics New Product Development – Plus Therapeutics, Inc.

Location: Charlottesville, VA, Houston, TX, or Remote

About the Company:

Plus Therapeutics, Inc. is a publicly-traded (Nasdaq: PSTV), clinical-stage pharmaceutical company developing novel targeted radiotherapeutics for patients with difficult-to-treat cancers of the central nervous system, with the potential to improve quality of life and extend survival. The Company is advancing a robust pipeline of drug candidates, with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).

CNSide Diagnostics, LLC is a subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary clinical diagnostic laboratory assays, such as CNSide™, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide™ assay enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the clinical management of patients. The Company is planning to commercialize CNSide™ in the U.S. as soon as Q4 2024.

Summary:

The Program Manager, New Product Development is a key team member within Plus Therapeutics and CNSide Diagnostics who leads fast-paced, cross-functional teams that develop and commercialize new diagnostic and therapeutic products in alignment with the Company’s strategic business priorities.  This U.S.-based position reports directly to the President/CEO and collaborates closely with internal stakeholders in Clinical/Medical Affairs, IT, Legal, Manufacturing, Marketing, Market Access, Quality, Regulatory, and Research/Development to advance the Company’s product pipeline, with a primary focus on CNSide™ launch readiness.

Responsibilities:

·      Lead multiple complex, high-visibility programs/projects simultaneously and drive to timely completion.

·      Create, communicate, and manage budgets, dashboards, meeting agendas/minutes, milestones, presentations, reports, and schedules/timelines for the programs you lead.

·      Identify and communicate resource needs to Leadership Team and implement risk mitigation strategies to keep programs/projects on budget and on time.

·      Maintain continuous alignment of program scope with strategic business objectives and utilize advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation, and conflict resolution.

·      Make or facilitate project trade-off decisions within the boundaries of the approved project contract.

·      Coordinate with internal stakeholders and translate their objectives and tasks into a master project plan and Gantt chart that identifies the critical path.

·      Assist with program documentation and define project phase gates in compliance with regulatory guidance and conjunction with other program/project managers.

·      Investigate, triage, and resolve problems, identifying root cause, and propose process improvements through clear communication with internal teams

Requirements:

·      Bachelor’s degree in biology, chemistry, engineering, healthcare, or a related field; Advanced degree preferred

·      5+ years relevant experience in program or project management; PMP certification preferred

·      Direct experience leading diagnostic medical device (lab developed test, in vitro diagnostic) programs from concept to commercialization; drug development experience is also a plus; oncology product experience is also a plus

Skills and Abilities:

·      Coordinate activities across departments and manage project inter-dependencies.

·      Detail oriented, organized, proactive, efficient, technical, and highly self-motivated.

·      Tackle a broad range of challenges as the company changes and grows.

·      Influence and motivate others without direct authority.

·      Excellent presentation and communication skills – written, verbal and interpersonal – with all levels of organization.

·      Excel within a mission-driven, patient-centric environment.

·      Strong critical thinking skills.

·      Focus on planning, execution, and results.

·      High level of professionalism, quality, and teamwork.

·      Demonstrated proficiency using MS Excel, PowerPoint, Project, and Word applications.

Additional Skills and Abilities:

·      Problem Solving

·      Team Motivation

·      Medical Devices

·      In Vitro Diagnostics (IVD)

·      Molecular Diagnostics

·      Cross-functional Team Leadership

·      Project Management

·      Product Development

·      Program Management

·      Communication

Equal Employment Opportunity

Plus Therapeutics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

Additional Benefits:

·      Medical

·      Dental

·      Vision

·      Life and Disability Insurance

·      401k with Company Match

·      …as well as additional benefits

Compensation: Commensurate with background and experience. 

Travel: up to 20% or as needed

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