Associate Project Director, Global Regulatory Affairs & Patient Safety

Ascendis Pharma A/S; Gentofte Kommune; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Ascendis Pharma A/S is seeking an experienced Associate Project Director to lead GRAPS Enablement & Insights initiatives globally. You will coordinate Regulatory Affairs, Patient Safety, and related functions, translating priorities into integrated plans across geographies and vendors.

You will report to the Chief Regulatory & Safety Officer and may be based in the US or Denmark, with travel to Ascendis locations as required. Strong governance and stakeholder management are essential.

Qualifications

• Demonstrated experience leading complex cross-functional projects.
• Strong command of project and program management disciplines.
• Experience in regulated pharma/biotech environments with regulatory knowledge.
• PMI/PRINCE2 certification preferred; Agile or change-management training is a plus.

Responsibilities

• Lead GRAPS projects from initiation through closeout with governance, milestones, and budgets.
• Translate priorities into roadmaps and a consolidated GRAPS portfolio view.
• Establish governance forums, dashboards, and concise executive materials.
• Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Quality, IT, Finance, HR, Legal.
• Drive standardization, scalable processes, and regulatory/compliance readiness.

Skills

Cross-functional leadership

Project management

Stakeholder management

Dashboards & reporting

Regulatory knowledge

Education

Bachelor's or Master's in life sciences, business, PM, engineering

Tools

Microsoft 365

Job description

Are you passionate about translating strategic priorities into disciplined execution? Do you have extensive experience leading complex, cross‑functional projects in the pharmaceutical or biotechnology industry? If so, now is your chance to join Ascendis Pharma as our new Associate Project Director, GRAPS.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best‑in‑class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease portfolios. We also collaborate with partners on the development of TransCon‑based products in other therapeutic areas and markets.

We are seeking an experienced and highly structured Associate Project Director to join our GRAPS Enablement & Insights function within Global Regulatory Affairs & Patient Safety.

In this role, you will translate GRAPS priorities into integrated plans and disciplined execution across Global Regulatory Affairs, Global Patient Safety, and key enterprise functions. You will lead strategic and operational initiatives involving multiple functions, geographies, vendors, and systems, while establishing clear governance, decision pathways, performance reporting, and risk management.

This is an exciting opportunity to combine strategic perspective with hands‑on project leadership in a global and highly regulated environment. You will work closely with the GRAPS Leadership Team, functional leaders, and cross‑functional stakeholders to strengthen quality, compliance, predictability, and organizational scalability.

You will join the GRAPS team (Global Regulatory Affairs & Patient Safety) and report directly to Jethro Ekuta, Chief Regulatory & Safety Officer, who is based in US.

The position may be based in US or DK, with travel to Ascendis Pharma locations and other business‑critical meetings as required.

Your key responsibilities will be:

• 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, and prepare concise 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 applicable GxP, regulatory, pharmacovigilance, documentation, training, inspection‑readiness, and records‑management requirements.

You will also provide project‑methodology guidance and coaching to workstream leads and more junior project‑management colleagues and may coordinate contractors or matrixed team members.

Qualifications and skills

You hold a relevant academic degree, preferably a bachelor’s or master’s degree in life sciences, business, project management, engineering, or a related discipline, and have at least 8 years of relevant experience from the pharmaceutical, biotechnology, or another highly regulated industry.

Furthermore, you have:

• 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.
• A project‑management certification such as PMP, PRINCE2, or equivalent is preferred. Agile or change‑management training would be considered an advantage.

Key competencies

You have an enterprise mindset and a strong patient focus, combined with sound judgment regarding business, quality, compliance, and reputational risk.

You are highly structured, analytical, and detail‑oriented while maintaining a clear focus on strategic objectives and outcomes. You can simplify complexity, frame options, recommend a path forward, and communicate decisions clearly to executive, technical, and operational audiences.

You are an experienced stakeholder manager who can build alignment, create accountability, and influence without formal authority. You are comfortable working with ambiguity, managing competing priorities, and adapting plans when business needs change.

As a person, you are collaborative, inclusive, culturally aware, and effective in a global matrix organization. You demonstrate high integrity, discretion, ownership, and a strong commitment to transparent communication and follow‑through.

Travel:

15-25 days a year.

Office:

Ascendis Pharma, Tuborg Boulevard 12, 2900 Hellerup