Jobs at Ascendis Pharma

Designs, oversees, monitors, and analyzes late-phase clinical trials for endocrine and oncology therapies. Responsibilities include developing clinical documents, tracking safety and efficacy data, supporting regulatory submissions, ensuring study integrity, collaborating with cross-functional teams, and engaging investigative sites, consultants, and key opinion leaders. The role requires advanced scientific training, clinical trial expertise, strong communication, sound judgment, and up to 20% domestic and international travel.

Leads complex GRAPS projects and programs across Regulatory Affairs, Patient Safety, and enterprise functions. Establishes governance, integrated plans, budgets, risk controls, reporting, and decision pathways; coordinates stakeholders, vendors, resources, and change initiatives. Ensures quality, compliance, inspection readiness, and scalable operating practices while communicating status and recommendations to executives. Provides coaching to workstream leads and junior project managers.

Develop and improve metadata-driven SDTM programming solutions for clinical trials. Responsibilities include creating and validating SDTM datasets, optimizing metadata, reviewing clinical data and specifications, supporting quality control, and ensuring regulatory-compliant, inspection-ready deliverables. The role collaborates with international cross-functional teams within a pharmaceutical biometrics organization.

Develops and implements global regulatory strategies across clinical, non-clinical, and CMC disciplines. Leads complex regulatory submissions, clinical and regulatory planning, risk mitigation, labeling, and cross-functional collaboration across international teams. Maintains regulatory expertise, assesses global requirements, influences project teams, and may mentor or supervise regulatory professionals. Requires extensive experience with regulatory dossiers, including CTAs, IMPDs, and INDs, plus knowledge of international regulatory requirements and trends.

Lead and support HR Operations projects across Europe, improve and standardize HR processes, and coordinate cross-functional initiatives. The role manages HR policies, procedures, governance, compliance, operational data, and employee lifecycle activities. It also identifies opportunities for automation and AI-enabled solutions, advises stakeholders, and supports daily HR operations. Success requires strong project management, analytical, communication, and stakeholder management skills in an international environment.

Marketing internship supporting promotional materials, communication plans, scientific and educational events, document management, conference logistics, public affairs initiatives, and cross-functional projects. The intern will collaborate with Marketing, Medical Affairs, Public Affairs, external vendors, patient associations, and the Italian Leadership Team while gaining exposure to pharmaceutical product lifecycle activities.

Leads clinical development systems, quality processes, inspection readiness, risk management, SOPs, audit responses, quality event tracking, and role-based training. Serves as a subject matter expert for GCP compliance, Veeva, Illuminate, Cornerstone, and the eTMF. Partners cross-functionally to improve processes, manage regulatory requirements, support inspections, and ensure effective training across global clinical development programs.

Lead pharmacovigilance activities for post-marketing Organized Data Collection programs, including process development, vendor oversight, adverse-event handling, compliance monitoring, CAPA implementation, and inspection readiness. Develop global PV processes, SOPs, and training materials while collaborating with GVP Compliance, Commercial, Medical Affairs, affiliates, and external service providers. Serve as a pharmacovigilance subject matter expert across global programs.

Develop and maintain global scientific training curricula for Medical Affairs teams, facilitate in-person and virtual learning sessions, assess training effectiveness, support employee onboarding and fellowship programs, and apply innovative learning technologies. The role collaborates with scientific subject matter experts, adapts content for diverse cultures and audiences, and promotes continuous learning across the organization.

Supports scientists and laboratory staff by troubleshooting laboratory hardware and software, configuring workstations and instrument-connected devices, managing specialized applications and licenses, and documenting IT solutions. Collaborates with global IT teams, subject matter experts, and service providers to maintain secure, stable, and compliant laboratory environments.

Supports finance operations by processing invoices, auditing expenses, managing accruals, maintaining expense management processes, creating and maintaining purchase orders, and administering corporate credit cards. Provides training, mailbox support, error resolution, and policy compliance assistance while collaborating with multiple business functions.

Designs and develops data products that translate business needs into actionable insights across the drug development domain. Responsibilities include gathering requirements, transforming complex data, building end-to-end analytics solutions, creating prototypes, and ensuring governance, compliance, and data quality. The role partners with global stakeholders and requires hands-on experience with DevOps, Databricks, dbt, Python, T-SQL, and Power BI.

Manages global and regional clinical trials from planning through completion, ensuring timelines, quality, ICH-GCP compliance, data integrity, and regulatory readiness. Responsibilities include site and investigator relationships, monitoring oversight, protocol deviation management, study team training, TMF and CTMS maintenance, vendor management, IRB submissions, audit preparation, clinical data review, and coordination with CRAs, data management, and clinical vendors.

Leads the pharmacovigilance Individual Case Safety Report management team, overseeing case processing, follow-up, regulatory submissions, vendor performance, quality, compliance, data integrity, CAPA, training, and process improvement. Advises cross-functional teams on drug safety, supports inspections and audits, collaborates on safety databases and reporting agreements, and manages team strategy, budgets, staffing, and organizational development.

Lead identification and assessment of new drug opportunities through deep biological, clinical, market, patent, and competitive analyses. Prepare high-quality reports and pitch decks, advise cross-functional teams, establish processes/templates, and track scientific and regulatory developments to support strategic decision-making.

Lead pharmacovigilance strategy and safety activities for assigned endocrinology products. Oversee signal detection, risk management, safety reporting, labeling input, regulatory submissions, audits/inspections, and cross-functional collaboration to ensure global compliance and patient safety across development and marketed programs.

Designs, oversees, and analyzes late-phase clinical trials in endocrinology and oncology. Produces and reviews clinical protocols, reports, regulatory documents, and site materials. Monitors safety and efficacy data, supports site and subject retention, collaborates cross-functionally, advises investigators and KOLs, and contributes to regulatory submissions and scientific communications. Travels up to 20% for meetings.

Lead U.S. KOL engagement and congress strategy for the endocrine portfolio, managing peer-to-peer education, speaker bureau, and advisory programs. Build and coach a Thought Leader Liaison team, partner cross-functionally to integrate insights into brand strategy, own budget/forecasting and compliance, and ensure on-time, on-budget delivery of programs. Report to VP of Marketing and support commercial leadership.

Lead development and execution of global publication plans for rare disease therapeutics. Collaborate with cross-functional teams and external experts, ensure compliance with publication standards, oversee tactical publication outputs, manage writers/vendors and budgets, and contribute to process improvement.

Serve as technical expert for eTMF, CTMS and IRT SaaS solutions supporting Clinical Operations and Clinical Trial Supply. Configure and validate systems, manage vendors and managed services, ensure inspection-readiness, oversee support and training, escalate tickets, and drive automation, integration and data flow improvements in collaboration with IT product teams.