(Sen.) Project Manager - Clinical Development (f/d/m)

CatalYm GmbH is seeking a (Sen.) Project Manager to support the Head of Program Management and cross-functional program teams in translating development strategy into coordinated, executable plans. The role provides day-to-day project management support across clinical development activities, including integrated planning, team coordination, governance preparation, risk and issue management, decision tracking, reporting, and follow-up of actions.
Working closely with Program Leadership and functional leads, the Project Manager ensures that milestones, dependencies, responsibilities, and emerging constraints are visible and actively followed. Functional and strategic decisions remain with the appropriate program and functional leaders; the Project Manager owns the coordination processes, planning tools, communication, and escalation needed to support timely delivery.

Key Responsibilities
Integrated Program Planning

• Support Program Leadership and functional leads in developing and maintaining integrated development plans across functions, indications, geographies, and external workstreams.
• Translate program strategy into clear milestones, deliverables, dependencies, decision points, and critical-path activities.
• Monitor progress against agreed plans and facilitate resolution or timely escalation of deviations, competing priorities, and resource constraints.
• Support scenario planning by coordinating cross-functional inputs and documenting options, trade-offs, assumptions, and implications for leadership review.

Cross-Functional Program & Team Coordination

• Coordinate Program Team, Project Team, and SubTeam operating cadences, including meeting calendars, agendas, pre-reads, minutes, action follow-up, and decision documentation.
• Coordinate activities spanning clinical data readouts, regulatory strategy updates, CMC deliverables, and launch or market-readiness planning, where relevant.
• Facilitate alignment across Clinical, Regulatory, CMC, Safety, Medical, Quality, Translational, Market Access, and Commercial functions, as applicable.
• Maintain effective information flow between Program Leadership, functional teams, governance bodies, and external partners.
• Promote clear responsibilities, accountability, and practical ways of working across cross-functional teams.

Governance, Decisions, Risks, and Reporting

• Coordinate preparation for governance interactions, including timelines, content integration, quality checks, risk and trade-off framing, and documentation of outcomes.
• Coordinate risk identification, mitigation and contingency planning, ownership, monitoring, and escalation.
• Maintain visibility of cross-functional issues and dependencies and ensure that appropriate owners and due dates are assigned.
• Prepare concise program status reports, dashboards, and decision-ready materials for program, functional, and senior leadership.
• Provide early escalation to the Head of Program Management and Program Leadership when issues may affect scope, timelines, budget, quality, or the critical path.

Project Management Tools and Ways of Working

• Use and continuously improve fit-for-purpose tools, templates, and standards for planning, reporting, governance preparation, and team collaboration.
• Share project management best practices and provide guidance to colleagues and teams where appropriate.
• Contribute to consistent and scalable project management practices across CatalYm development programs.

Budget, Resources, and External Partners

• Support Finance and functional leads with program budget development, forecasting, actual-versus-forecast tracking, and identification of material variances as needed.

Required

• Bachelor’s degree in life sciences, public health, business, or a related field; an advanced degree is preferred.
• Relevant experience in biotechnology or pharmaceutical drug development and cross-functional program or project management.
• Understanding of the end-to-end clinical development process and experience working in a GxP-regulated environment.
• Experience developing and maintaining integrated plans, milestones, dependencies, critical paths, risks, actions, and decisions.
• Experience coordinating complex cross-functional teams and preparing materials for program or governance forums.
• Experience supporting budget planning, forecasting, and financial tracking for development programs.
• Strong communication and facilitation skills, including the ability to translate complex inputs into clear status updates, scenarios, and decision-ready materials.
• Professional fluency in written and spoken English.

Preferred

• Experience late-stage clinical development, regulatory submissions, or major health-authority interactions.
• Experience in oncology drug development.
• Experience working with external partners, vendors, alliances, or co-development collaborations.
• Experience using and improving project management tools, templates, standards, and operating practices.

Core Competencies

• Strong operational thinking with the ability to connect execution to program strategy
• Structured, detail-oriented, and reliable, with strong follow-through
• Collaborative and able to influence across functions without direct authority
• Skilled at facilitating meetings, resolving ambiguity, and maintaining momentum
• Able to synthesize complex information into clear options, trade-offs, and recommendations
• Comfortable working at pace with evolving priorities and multiple parallel workstreams
• Proactive in identifying risks, dependencies, and issues requiring attention