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Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Associate Project Director - Global Regulatory Affairs & Patient Safety

Program ManagementConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • Hold a relevant academic degree; a bachelor's or master's degree in life sciences, business, project management, engineering, or a related discipline is preferred.
  • Have at least 8 years of relevant experience in the pharmaceutical, biotechnology, or another highly regulated industry.
  • Demonstrate experience leading complex, cross-functional projects, programs, or major workstreams involving senior stakeholders, multiple functions, geographies, vendors, or systems.
  • Have strong command of project and program management disciplines, including scope, schedule, governance, resources, budgets, dependencies, risks, issues, change control, and benefits realization.
  • Have working knowledge of drug development and commercialization; experience in Regulatory Affairs, Pharmacovigilance, Patient Safety, Quality, Regulatory Operations, or a closely related function is preferred.
  • Have experience creating executive-ready dashboards, status reports, decision materials, and presentations using Microsoft 365 and relevant project-management or reporting tools.
  • Demonstrate sound judgment regarding business, quality, compliance, and reputational risk; be structured, analytical, and detail-oriented while maintaining focus on strategic objectives and outcomes.
  • Be able to simplify complexity, frame options, recommend a path forward, and communicate decisions clearly to executive, technical, and operational audiences.
  • Be able to build stakeholder alignment, create accountability, and influence without formal authority; work with ambiguity, competing priorities, and changing business needs.
  • Demonstrate collaboration, inclusiveness, cultural awareness, integrity, discretion, ownership, transparent communication, and follow-through.
  • Applications must be submitted in English.

Responsibilities

  • Lead assigned Global Regulatory Affairs & Patient Safety projects and programs from initiation through closeout, establishing scope, objectives, governance, integrated plans, milestones, accountabilities, dependencies, budgets, risk controls, and measurable outcomes.
  • Partner with Global Regulatory Affairs & Patient Safety leaders to translate strategic priorities into roadmaps and sequenced execution plans, maintaining a consolidated view of the project portfolio, capacity constraints, interdependencies, risks, and decisions requiring leadership attention.
  • Establish and facilitate governance, steering forums, workshops, stage reviews, and decision-making processes, and prepare executive dashboards, status reports, decision materials, and recommendations.
  • Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Medical Affairs, Quality, IT, Finance, Human Resources, Legal, Procurement, and external partners, clarifying 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.
  • Provide project-methodology guidance and coaching to workstream leads and more junior project-management colleagues, and coordinate contractors or matrixed team members as needed.

Desired Qualifications

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

About the Company

Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Ascendis Pharma uses its TransCon technology to create long-acting prodrugs for rare endocrine diseases, with expansions into oncology and ophthalmology. The platform temporarily attaches an unmodified drug to an inert carrier and releases the active drug in a predictable, sustained way after injection, reducing how often patients must dosing. It differentiates itself through a proprietary delivery system and a track record that includes marketed therapies like SKYTROFA for pediatric growth hormone deficiency and YORVIPATH for hypoparathyroidism, along with collaborations such as a Novo Nordisk deal. The company aims to improve patient outcomes by enabling easier, less frequent dosing while expanding its pipeline across rare endocrine diseases, cancer, and eye diseases.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Gentofte Municipality, Denmark
Founded
2007

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