Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
Position summary
The Associate Project Director, GRAPS is a senior project-management professional who translates GRAPS priorities into disciplined execution across Global Regulatory Affairs, Global Patient Safety, and enterprise partners. The role establishes fit-for-purpose governance, integrated plans, decision pathways, performance reporting, and risk management for a portfolio of strategic and operational initiatives.
Working with the Chief Regulatory & Safety Officer, GRAPS Leadership Team, functional leaders, and cross-functional stakeholders, this individual will lead small-to-medium, complex projects and selected larger workstreams that require coordination across functions, geographies, vendors, and systems. The role combines strategic perspective with hands-on delivery and is expected to influence without authority, improve ways of working, and strengthen quality, compliance, predictability, and organizational scalability.
Key responsibilities
Strategic portfolio and project leadership
• Lead assigned GRAPS projects and programs from definition through closeout, with clear charters, scope, objectives, outcomes, milestones, owners, dependencies, and success measures.
• Partner with GRAPS leaders to translate strategic priorities into integrated roadmaps and sequenced execution plans aligned with portfolio and enterprise objectives.
• Maintain a consolidated view of the GRAPS project portfolio, distinguishing project work from base-business activity and highlighting capacity constraints, interdependencies, and decisions required.
• Facilitate project initiation, prioritization, stage reviews, lessons learned, and benefits realization.
Governance, planning, and delivery
• Establish and run proportionate governance, including core teams, steering forums, agendas, decision logs, action tracking, and escalation pathways.
• Develop and maintain integrated project plans, critical paths, resource assumptions, budgets, RAID (Risks, Assumptions, Issues, and Dependencies or Decisions) logs, and change controls.
• Monitor execution against scope, schedule, quality, cost, and expected outcomes; identify emerging issues early and drive recovery plans.
• Prepare concise executive dashboards, status reports, decision memos, and recommendations for the GRAPS Leadership Team and other governance bodies.
Cross-functional collaboration and communication
• Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Medical Affairs, Quality, IT, Finance, HR, Legal, Procurement, and external partners, as applicable.
• Create clarity on roles, accountabilities, interfaces, and handoffs, using fit-for-purpose RACI or equivalent tools.
• Facilitate complex workshops and working sessions that align stakeholders, resolve ambiguity, and convert discussion into decisions and accountable actions.
• Communicate proactively and tailor content for executive, technical, and operational audiences across cultures and time zones.
Operational excellence, quality, and compliance
• Identify opportunities to standardize, simplify, and scale GRAPS processes, templates, tools, and operating practices.
• Partner with process owners and Quality to ensure project deliverables support applicable GxP, regulatory, pharmacovigilance, documentation, training, inspection-readiness, and records-management requirements.
• Use data and trend analysis to monitor performance, identify root causes, and recommend sustainable improvements.
• Support adoption of digital project-management, collaboration, dashboarding, workflow, and knowledge-management capabilities.
Resource, vendor, and change management
• Coordinate resource planning for assigned initiatives and surface trade-offs requiring leadership action.
• Support vendor selection, statements of work, onboarding, purchase-order coordination, deliverable oversight, and performance monitoring in partnership with Procurement and Finance.
• Develop stakeholder and change-impact assessments, communication plans, readiness activities, and adoption measures for new processes, systems, and operating models.
• Provide direction, coaching, and project-methodology support to workstream leads and more junior project-management colleagues; may lead contractors or matrixed team members.
Professional qualifications
• Bachelor’s degree in life sciences, business, project management, engineering, or a related discipline; advanced degree is preferred.
• Typically 8 or more years of relevant experience in the pharmaceutical, biotechnology, or other highly regulated industry, including substantial responsibility for cross-functional project or program delivery.
• Demonstrated experience leading small-to-medium complex projects or major workstreams with functional-management stakeholders and limited day-to-day supervision.
• Working knowledge of drug development and commercialization, with experience in Regulatory Affairs, Pharmacovigilance/Patient Safety, Quality, Regulatory Operations, or adjacent functions strongly preferred.
• Demonstrated command of project and program management practices, including scope, schedule, resource, budget, dependency, risk, issue, change, governance, and benefits management.
• Experience preparin