Ascendis Pharma

Clinical Research

• Design clinical trials, provide oversight, and support site and subject retention
• Ensure completion of clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, and related documents
• Participate on study teams and cross-functional teams as delegated by the Vice President, Clinical Development
• Ensure consistent use of language and criteria across multiple endocrine projects
• Ensure study integrity and track accumulating safety and efficacy data
• Anticipate clinical trial obstacles and implement solutions
• Analyze, evaluate, and support accurate interpretation and reporting of clinical data
• Draft and review clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain current knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with cross-functional colleagues as a clinical research resource to optimize product development
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders
• Support corporate strategic and organizational initiatives
• Assist with commercial activities as needed
• Complete assigned tasks thoroughly, accurately, and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings

Clinical Scientist

Medical Director

• Contribute to formulation and implementation of the Clinical Development Plan
• Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program
• Design clinical trials, provide overall oversight, and support site and subject retention
• Serve as Medical Monitor, ensure study integrity, and track accumulating safety and efficacy data
• Provide leadership to teams of medical monitors and study teams
• Ensure completion of trial-related documents, including protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, and regulatory documents
• Analyze, evaluate, interpret, and report clinical data
• Anticipate and solve complex drug development problems
• Contribute to regulatory strategy and clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain current knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with cross-functional colleagues to optimize product development
• Contribute to corporate strategic and organizational initiatives
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders
• Assist in portfolio management and commercial activities as needed
• Complete assigned tasks accurately and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings
• Report to the Vice President, Clinical Science

Medical Director, Clinical Development

Content Marketing Manager

• Own and evolve the global Medical content governance framework, including policies, standards, taxonomy, metadata strategy, content architecture, and lifecycle management
• Establish and maintain an integrated operating model across Medical Affairs, Regulatory Affairs, Market Access, Commercial, and IT
• Define governance structures, decision rights, prioritization frameworks, and cross-functional steering committees
• Lead resolution of competing stakeholder priorities and drive balanced decisions
• Develop global standards for content repositories and ensure alignment with enterprise architecture principles
• Establish and maintain content management best practices across regions and functions
• Serve as senior business owner and primary Medical Affairs representative for Veeva MedComms and related content management platforms
• Partner with IT on platform roadmaps, enhancement priorities, investment strategies, and capability development
• Translate business requirements into scalable technical solutions
• Lead governance and prioritization of system enhancements, backlog management, taxonomy changes, workflow optimizations, and new capability implementation
• Oversee platform adoption, training, user support models, and change management initiatives
• Collaborate with vendors and internal technical teams to optimize system performance and user experience
• Provide strategic oversight for global medical and non-promotional content review processes
• Establish standards for content submission, review, approval, documentation, and audit readiness
• Oversee review governance forums, prioritization processes, escalation pathways, and decision documentation
• Support product launches, new indications, data disclosures, and label updates through effective content review planning
• Drive continuous process improvement to reduce cycle times and enhance review quality
• Act as primary liaison among Medical Affairs, Regulatory Affairs, Market Access, Commercial, Legal, Compliance, and Information Technology
• Build relationships with senior leaders and chair governance committees
• Influence stakeholders across organizational boundaries without direct authority
• Develop performance measurement frameworks, KPIs, executive dashboards, and reporting capabilities
• Monitor trends and identify optimization and innovation opportunities
• Lead global change management strategies, communication plans, training programs, knowledge resources, and adoption campaigns
• Build organizational capability through education, coaching, and stakeholder engagement

Global Medical Affairs Planning & Effectiveness, Content Platform Lead

Director

• Lead assigned GRAPS projects and programs from definition through closeout
• Translate strategic priorities into integrated roadmaps and sequenced execution plans
• Maintain a consolidated view of the GRAPS project portfolio, capacity constraints, interdependencies, and required decisions
• Facilitate project initiation, prioritization, stage reviews, lessons learned, and benefits realization
• Establish and run proportionate governance, including core teams, steering forums, decision logs, action tracking, and escalation pathways
• Develop and maintain integrated project plans, critical paths, resource assumptions, budgets, RAID logs, and change controls
• Monitor execution against scope, schedule, quality, cost, and expected outcomes; identify issues and drive recovery plans
• Prepare executive dashboards, status reports, decision memos, and recommendations
• Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Medical Affairs, Quality, IT, Finance, HR, Legal, Procurement, and external partners
• Clarify roles, accountabilities, interfaces, and handoffs using RACI or equivalent tools
• Facilitate complex workshops and working sessions to align stakeholders, resolve ambiguity, and convert discussion into decisions and actions
• Communicate proactively and tailor content for executive, technical, and operational audiences across cultures and time zones
• Standardize, simplify, and scale GRAPS processes, templates, tools, and operating practices
• Partner with process owners and Quality to support 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
• Coordinate resource planning and surface trade-offs requiring leadership action
• Support vendor selection, statements of work, onboarding, purchase-order coordination, deliverable oversight, and performance monitoring
• Develop stakeholder and change-impact assessments, communication plans, readiness activities, and adoption measures
• Provide direction, coaching, and project-methodology support to workstream leads and junior project-management colleagues; may lead contractors or matrixed team members
• Deliver projects with agreed scope, governance, milestones, risk controls, measurable outcomes, and timely escalation

Associate Project Director, GRAPS

Operations

• Manage the end-to-end lifecycle of print and physical commercial assets across U.S. brands
• Oversee print production, including specifications, quantities, schedules, proofs, approvals, vendors, and delivery timelines
• Manage warehousing, inventory, fulfillment, distribution, rework, relabeling, replenishment, and compliant destruction of commercial and educational materials
• Administer field ordering and direct-to-representative fulfillment programs and platforms
• Coordinate field and patient-support kits, including sourcing, assembly, inventory, distribution, and specialty pharmacy delivery
• Lead cross-functional Commercial Operations projects from initiation through implementation and closeout
• Develop project plans, dashboards, templates, governance processes, and process improvements
• Facilitate meetings, document decisions, track actions, communicate status, and resolve risks and dependencies
• Manage print, warehousing, fulfillment, logistics, and related third-party vendors
• Partner with Procurement and Finance on vendor selection, contracting, purchase orders, invoices, budgets, and financial planning
• Manage OPDP submission execution and lead PRC agenda planning and facilitation
• Liaise with Veeva PromoMats IT and provide backup support for PRC Process Lead responsibilities
• Support field inquiries, ordering, inventory, shipments, fulfillment, onboarding, offboarding, and resource access
• Develop job aids, training materials, and onboarding support
• Administer field ordering and resource platforms, including user setup, access management, testing, and training
• Ensure production, storage, fulfillment, and distribution comply with company policies, SOPs, business rules, and promotional requirements
• Maintain operational documentation and records for internal controls and inspection readiness
• Monitor performance measures and analyze operational trends to improve service, scalability, cost efficiency, and field experience

Manager, Commercial Asset Management – Operations

Compliance

• Develop and implement global regulatory strategies covering clinical, non-clinical, and CMC disciplines
• Ensure timely preparation of organized and scientifically valid submissions
• Translate regulatory requirements into practical plans for project teams with international participants
• Provide strategic and operational regulatory input for cross-functional CMC, non-clinical, and clinical areas
• Collaborate with CMC regulatory team members and other project team members
• Contribute to global clinical and regulatory plans and strategies
• Identify and propose risk mitigation strategies
• Influence project teams and subteams across international site locations
• Contribute to global labeling documents, including prescribing information and patient information
• Prepare and/or manage technically complex submissions
• Interact extensively with departments outside Regulatory Affairs
• Maintain current knowledge of complex regulatory requirements
• Communicate regulatory information changes to project teams
• Schedule and arrange own activities and those of direct reports
• Mentor and potentially supervise regulatory professionals
• Work under the direction of a Senior Regulatory Affairs professional

Director, Global Regulatory Affairs, Clinical Strategy

• Serve as the scientific expert for medical affairs across APAC
• Design and implement medical strategies and tactical plans
• Support development of clinical and real-world evidence
• Input into lifecycle management activities as needed
• Oversee compassionate use programs and grants as needed
• Apply deep understanding of compliance in APAC markets
• Establish and nurture relationships with KOLs and key centres in international markets
• Monitor competitive landscape, new therapies, and clinical trends
• Lead medical education programs targeted to APAC in collaboration with therapeutic area medical leads
• Collaborate with IM medical, commercial, business operations, and other functions
• Manage key external vendors and agencies to ensure optimal delivery
• Provide mentorship and functional leadership to medical teams and stakeholders
• Report to the Head of International Medical Affairs
• Work closely with medical directors, the APAC commercial manager, and internal Ascendis teams

Associate Director, Medical Affairs – APAC

• Maintain an overview of systems and processes relevant to Clinical Development and their interfaces
• Monitor systems and processes to identify SOP changes, coordinate document updates, and initiate new documents
• Analyze and refine system and process interfaces across the molecule lifecycle
• Promote consistency and efficiency across teams and programs
• Serve as Clinical Development Super User for Veeva and illuminate
• Act as TMF Ambassador for Clinical Development
• Liaise with IT on behalf of Clinical Development
• Provide expert advice on identifying, managing, and mitigating risks in clinical trials and development strategy
• Promote quality-by-design from study conception through reporting of study results
• Coordinate inspection-readiness activities and maintain the eTMF and other documentation
• Partner with SMEs to mitigate risks and formulate responses to audit and inspection findings
• Coordinate deviations, investigations, root cause analyses, corrective/preventive actions, and change controls
• Track, review, and analyze audit, inspection, and quality-event data to identify trends and exposure areas
• Act as Clinical Development SME on Monitoring of External Requirements (MER)
• Monitor GCP, industry trends, practices, and regulatory guidelines and assess their impact
• Drive cross-functional GxP best practices and continuous improvement
• Provide guidance on interpreting and applying regulations to Clinical Development
• Optimize training based on team roles and timing
• Maintain feedback loops between outcomes, processes, systems, and training
• Direct SOP training and arrange event-related and system training
• Act as Cornerstone Learning Administrator for Clinical Development
• Ensure adequate training documentation