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Ascendis Pharma, a global biopharmaceutical company, is seeking an Associate Project Director to join the Global Regulatory Affairs & Patient Safety (GRAPS) Enablement & Insights function. You will report directly to the Chief Regulatory & Safety Officer and translate strategic priorities into integrated execution plans across regulatory affairs, patient safety, and enterprise functions.
Key Responsibilities:
- Lead assigned GRAPS projects and programs from initiation through closeout, establishing clear scope, objectives, governance, integrated plans, milestones, accountabilities, dependencies, budgets, risk controls, and measurable outcomes.
- Partner with GRAPS leaders to translate strategic priorities into roadmaps and sequenced execution plans while maintaining a consolidated view of the GRAPS project portfolio, including capacity constraints, interdependencies, risks, and decisions requiring leadership attention.
- Establish and facilitate fit-for-purpose governance, steering forums, workshops, stage reviews, and decision-making processes; prepare executive dashboards, status reports, decision materials, and recommendations.
- Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Medical Affairs, Quality, IT, Finance, HR, Legal, Procurement, and external partners, creating clarity around roles, responsibilities, interfaces, and handoffs.
- Drive operational excellence and sustainable change by identifying opportunities to standardize, simplify, and scale processes, tools, and ways of working while supporting GxP, regulatory, pharmacovigilance, documentation, training, inspection-readiness, and records-management requirements.
- Provide project-methodology guidance and coaching to workstream leads and junior project-management colleagues; may coordinate contractors or matrixed team members.
The role is based in Hellerup, Denmark (with a US option available) and requires 15–25 days of travel annually to Ascendis Pharma locations and business-critical meetings.
Ascendis Pharma operates research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, advancing programs in Endocrinology and Rare Disease portfolios using its proprietary TransCon® technology platform.
Qualifications:
- Bachelor's or master's degree in life sciences, business, project management, engineering, or a related discipline.
- At least 8 years of relevant experience in the pharmaceutical, biotechnology, or another highly regulated industry.
- Demonstrated experience leading complex, cross-functional projects, programs, or major workstreams involving senior stakeholders, multiple functions, geographies, vendors, or systems.
- Strong command of project and program management disciplines, including scope, schedule, governance, resources, budgets, dependencies, risks, issues, change control, and benefits realization.
- Working knowledge of drug development and commercialization, preferably combined with experience in Regulatory Affairs, Pharmacovigilance, Patient Safety, Quality, Regulatory Operations, or a closely related function.
- Experience creating executive-ready dashboards, status reports, decision materials, and presentations using Microsoft 365 and relevant project-management or reporting tools.
- Project-management certification such as PMP, PRINCE2, or equivalent is preferred; Agile or change-management training is considered an advantage.
Key Competencies:
- Enterprise mindset with strong patient focus and sound judgment regarding business, quality, compliance, and reputational risk.
- Highly structured, analytical, and detail-oriented while maintaining clear focus on strategic objectives and outcomes.
- Ability to simplify complexity, frame options, recommend a path forward, and communicate decisions clearly to executive, technical, and operational audiences.
- Experienced stakeholder manager who can build alignment, create accountability, and influence without formal authority.
- Comfortable working with ambiguity, managing competing priorities, and adapting plans when business needs change.
- Collaborative, inclusive, culturally aware, and effective in a global matrix organization.
- High integrity, discretion, ownership, and strong commitment to transparent communication and follow-through.
