Project Manager

The Steely Group; Jersey City (NJ); Hybrid; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

The Steely Group is seeking an experienced Project Manager, R&D, in Jersey City, NJ to support planning, coordination, and execution of outsourced preclinical studies and broader R&D activities. This role emphasizes operational management, vendor oversight, budgeting, and cross-functional collaboration to drive programs on time and within scope.

The ideal candidate has 7+ years in biotech/pharma project management, strong communication skills, and a proven track record coordinating CROs and

Qualifikationen

• Bachelor's degree and 7+ years in biotech/pharma project management.
• Experience coordinating CROs, labs, consultants, and vendors.
• Strong planning, budgeting, risk management, and governance skills.
• Experience with IND-enabling activities or preclinical programs preferred.

Aufgaben

• Develop and maintain integrated R&D project plans aligned with milestones.
• Coordinate outsourced preclinical studies across internal teams and vendors.
• Manage timelines, deliverables, dependencies, risks, and critical paths.
• Serve as operational liaison between internal teams and CROs/consultants.
• Oversee vendor selection, RFP/RFQ processes and contract scoping.
• Track budgets, expenditures, forecast spend, and identify cost-saving opportunities.
• Maintain study records, trackers, and documentation repositories.
• Prepare documentation for regulatory submissions, including IND-enabling programs.
• Create dashboards and status reports for program visibility.
• Drive continuous improvement of preclinical operational processes.

Kenntnisse

R&D project management

Vendor management

Cross-functional coordination

Budget management

Preclinical operations

Regulatory submissions support

Communication with stakeholders

Ausbildung

Bachelor's degree in Life Sciences, Business, Operations, or related field

Tools

Smartsheet

Microsoft Project

Microsoft Office

Jobbeschreibung

The Project Manager, R&D, is responsible for supporting the planning, coordination, execution, and oversight of R&D projects and operational activities that advance development programs. The primary focus of the role will be outsourced preclinical studies, including pharmacology, toxicology, DMPK/ADME, and bioanalysis activities; however, the position may also support broader project management responsibilities across R&D as business needs evolve. This role helps scope, contract, schedule, track, and complete studies and project deliverables on time, within budget, and in accordance with quality, regulatory, and compliance requirements. The position serves as an operational interface between internal functional teams and external CROs, laboratories, consultants, and service providers, driving day-to-day execution, issue resolution, and progress across multiple concurrent development activities. This is a project management and operations-focused role rather than a scientific research position. It requires strong project planning, vendor oversight, cross-functional coordination, budget management, stakeholder communication, and organizational skills, with demonstrated ability to support preclinical operations and adapt to additional R&D project management needs.

Responsibilities

• Develop and maintain integrated R&D project plans, with emphasis on preclinical operational plans, aligned with program milestones, regulatory timelines, and corporate objectives in partnership with Program Management and cross-functional leads.
• Coordinate the initiation, execution, and closeout of outsourced preclinical studies and other assigned R&D project workstreams across internal teams and external vendors.
• Manage project and study timelines, deliverables, dependencies, risks, and critical path activities to ensure on-time and high-quality execution.
• Serve as the primary operational liaison between internal functional teams and external CROs, laboratories, consultants, and service providers.
• Coordinate vendor selection activities, including RFP/RFQ processes, proposal evaluation, and contract scoping.
• Oversee CRO and vendor performance through governance meetings, action tracking, issue resolution, and performance monitoring.
• Partner with Procurement, Legal, and Finance to manage contracts, statements of work, change orders, and vendor relationships.
• Track program budgets, monitor expenditures, forecast spend, and identify cost-saving opportunities and budget risks.
• Coordinate study logistics, including sample shipments, test article management, and chain-of-custody documentation in partnership with CMC and Supply Chain teams.
• Maintain centralized study records, operational trackers, and documentation repositories that support audit and inspection readiness.
• Ensure deliverables, reports, and study documentation meet agreed quality standards and timelines.
• Support preparation of documentation and operational activities related to regulatory submissions, including IND-enabling programs.
• Facilitate cross-functional communication, governance meetings, decision tracking, action item follow-up, and stakeholder reporting to ensure organizational alignment across R&D projects.
• Create and maintain project dashboards, integrated timelines, status reports, key performance metrics, decision logs, and risk management tools to support program and portfolio visibility.
• Support additional R&D project management activities as assigned, which may include planning, tracking, coordination, and reporting for discovery, development, regulatory, clinical, CMC, or portfolio-related initiatives.
• Drive continuous improvement of preclinical operational processes, including SOPs, templates, tools, and best practices that enhance efficiency, transparency, and scalability.

Requirements and Preferred Skills

Bachelor's degree in Life Sciences, Business, Operations, or a related field, with a minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, including R&D project management, development operations, preclinical operations, program management, and/or CRO and vendor management. Demonstrated experience managing cross-functional R&D projects and/or outsourced studies, coordinating activities across internal teams, CROs, laboratories, consultants, and service providers to deliver program objectives on time and within budget. Strong project management expertise, including project planning, timeline management, budgeting, forecasting, risk mitigation, contract administration, stakeholder communication, meeting facilitation, and action tracking. Experience supporting preclinical development programs is strongly preferred, including toxicology, DMPK/ADME, bioanalysis, pharmacology, and other IND-enabling activities. Proven ability to build and manage productive vendor relationships while driving accountability, performance, and issue resolution. Strong organizational skills with the ability to manage multiple studies, priorities, timelines, and deliverables in a dynamic environment. Excellent written and verbal communication skills, including the ability to translate scientific objectives into clear operational plans, status updates, and executive communications. Experience supporting audit readiness, documentation management, regulatory submission activities, and compliance-related processes. Ability and willingness to support a range of R&D project management needs beyond preclinical operations, based on portfolio priorities and evolving business needs. Proficiency with Microsoft Office applications and project management tools such as Smartsheet, Microsoft Project, or similar platforms. Experience in a small to mid-sized biotechnology environment and project management certification (e.g., PMP, CAPM, or equivalent) are preferred. Occasional travel (e.g., 0–15%) for vendor meetings, audits (if applicable), or internal planning sessions.