Project Manager R&D

Mission

The Project Manager is responsible for planning, coordinating, governing, monitoring, and controlling complex projects and programs within Pharmaceutical Research & Development, with a particular focus on preclinical development, clinical development, and pharmaceutical product development.

The role ensures effective cross-functional integration and alignment among all stakeholders involved, driving the successful delivery of projects in terms of timelines, budget, quality, regulatory compliance, and risk management.

The position also contributes to the development and continuous improvement of the Project Management Office (PMO), supporting the implementation of project management methodologies, governance models, standardized processes, and digital tools aimed at strengthening portfolio management capabilities across the organization.

**Key Responsibilities
Project & Program Management**

• Plan, coordinate, and manage complex projects and programs across Research & Development, preclinical and clinical development.

• Ensure project delivery in accordance with agreed timelines, budget, quality standards, regulatory requirements, and business objectives.

• Develop and maintain Project Charters, Project Management Plans, schedules, milestones, deliverables, project dependencies, and critical paths.

• Monitor project performance through KPIs, dashboards, and reporting tools, proactively identifying risks, issues, opportunities, and mitigation actions.

• Lead multidisciplinary, cross-functional teams, fostering collaboration, accountability, and alignment across all business functions, involving Regulatory Affairs activities.

• Support the integration of regulatory requirements, timelines, milestones and deliverables into the overall project plan, ensuring alignment with development strategy and project priorities.

• Act as a project management facilitator between Regulatory Affairs and other functions, without assuming ownership of regulatory strategy or decisions, which remain under the responsibility of the relevant subject-matter experts.

• Support management decision-making by providing project analyses, performance reporting, and actionable recommendations.

• Manage relationships with internal and external stakeholders, ensuring effective communication, engagement, and alignment throughout the project lifecycle.

• Coordinate project resource planning and prioritization activities, supporting effective workload balancing and optimal resource utilization.

• Manage project risks, issues, change requests, and mitigation plans throughout the entire project lifecycle.

• Support the R&D Team in the management of strategic suppliers (CDROs and external laboratories), highlighting discrepancies from planning and suggesting corrective actions.

• Carrying out Mentoring and Coaching activities within the team to enhance the knowledge of the Scientific project management.

PMO, Portfolio Management & Continuous Improvement**

• Contribute to the development and continuous enhancement of the company's Project and Program Management framework.

• Design and implement project management methodologies, standards, templates, processes, and best practices.

• Support portfolio governance activities, including project prioritization, capacity planning, and resource allocation.

• Contribute to the development of executive portfolio reporting and performance dashboards.

• Promote Project Management best practices and foster a project management culture across the organization.

• Support continuous improvement initiatives aimed at increasing efficiency, transparency, consistency, and governance in project execution.

• Promote the adoption of digital tools supporting integrated project and portfolio management.

QualificationsEducation

• Master's Degree in Pharmaceutical Chemistry (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Biomedical Engineering, Life Sciences, or a related scientific discipline.

• Professional Project Management certifications such as PMP®, PRINCE2®, IPMA®, Agile, or equivalent are considered a strong asset.

Professional Experience

• Minimum of 7+ years of experience managing complex projects within the pharmaceutical industry, preferably across preclinical, clinical development, R&D and/or regulatory-related projects.

• Proven experience leading projects and programs in:

• Research & Development (R&D)

• Preclinical Development

• Clinical Development

• Demonstrated experience managing cross-functional projects involving Scientific, Regulatory Affairs, Manufacturing, Quality, Supply Chain, and Technical Operations.

• Good understanding of the role of Regulatory Affairs within pharmaceutical development, including the interaction between regulatory strategy, clinical development, CMC, quality and preclinical activities.

• Experience managing Contract Research Organizations (CROs), external laboratories, and development partners.

• Experience developing and implementing PMO, Program Management, and Portfolio Management methodologies and governance frameworks.

• Previous experience in the development of the following products will be considered a strong advantage:

• Hormonal products

• Anti-inflammatory products

• Hyaluronic acid-based products

• Medical Devices

Technical Competencies (Hard Skills)

• Strong knowledge of pharmaceutical Research & Development processes, including preclinical and clinical development.

• Advanced expertise in Project, Program, and Portfolio Management methodologies.

• Proven experience managing the complete project lifecycle from initiation through closure.

• Strong planning, scheduling, budgeting, resource management, and project control capabilities.

• Experience in project financial management and budget control.

• Sound knowledge of Risk Management, Issue Management, and Change Management methodologies.

• Experience developing KPIs, executive dashboards, and project performance reporting.

• Proven ability to design and implement structured PMO methodologies and governance frameworks.

• Hands-on experience with Project and Portfolio Management software such as Microsoft Project, Primavera P6, or equivalent platforms.

• Advanced proficiency in Microsoft Office, particularly Microsoft Excel.

• Extensive hands-on experience with Planisware Enterprise will be considered a highly preferred qualification and a significant differentiating factor. Candidates should demonstrate advanced knowledge of portfolio management, integrated project planning, resource and capacity planning, financial tracking, and governance of pharmaceutical R&D programs using the Planisware platform.

• Excellent command of English, both written and spoken.