Project Manager R&D

Project Manager, R&D

Company is seeking an experienced Project Manager, R&D, (hybrid Jersey City, NJ). Reporting to the Director, Program Management, this role will support the planning and operational execution of R&D programs and cross-functional initiatives, with a strong emphasis on outsourced preclinical development activities. The position will help ensure projects, studies, and vendor-supported activities are delivered efficiently, compliantly, and in alignment with program, regulatory, and corporate objectives defined by cross-functional leaders.

Position Summary:

The Project Manager, R&D is responsible for supporting the planning, coordination, execution, and oversight of R&D projects and operational activities that advance Company’s development programs. This role will be primarily working on our preclinical and Phase I trials. However, our company has later phase trials (and commercial products). Candidates should have experience as a PM for Drug Development and Clinical Trials within the Pharmaceutical and Biotech Industry.

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.