Ascendis Pharma

Compliance

• Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members, including CMC regulatory team members.
• Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Contributes to development of global labeling documents (prescribing information and patient information).
• Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
• Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams.
• Schedules and arranges own activities and those of direct reports.
• Work is performed under direction of a Senior Regulatory Affairs professional.

Associate Director, Global Regulatory Affairs Clinical Strategy

Clinical Research

• Foster and maintain favorable clinical site and investigator relationships. Including conducting and/or supporting informational calls for sites and investigators.
• Support in planning and conducting investigator meetings, if applicable.
• Review and/or approve of IP release packages.
• Review monitoring reports for compliance to study protocols, regulations and ICH/GCP. Track and manage monitoring report metrics. If applicable, serve as a backup monitor to the monitoring team.
• Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plans and communicates issues to Director and CRAs as appropriate.
• Ensure accurate reporting of Protocol Deviations and follows up with monitoring team of any subsequent re-SDV and close out of PDs if applicable.
• Provides any assistance with findings from Protocol Deviation Review Team meetings and disseminates any applicable information to the CRA team.
• Conducts monitoring meetings, creating agendas and meeting minutes which may include but is not limited to: monitoring team training and tracking, report quality issues, site level issues/trends in data and EDC metrics reporting.
• Assist in coordinating study specific training or re-training for the internal study team, internal monitoring team and site staff as appropriate.
• Responsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in Veeva Vault which includes quarterly eTMF reviews. Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions.
• Manages and/or supports vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems including but not limited to: portal access management for sites and internal teams, report review, sample tracking, metrics review, document reviews and meeting participation
• Facilitate EDC and IRT access requests for site teams.
• Facilitate CRA team access to internal Ascendis systems such as TMF, EDC and vendor systems (e.g. IRT).
• Assist and manage CRA transition meetings which may include creating and/or reviewing transition documentation
• Run Study Team Meetings including providing agendas and meeting minutes.
• Reviews site information/informed consents and completes associated checklists as per Ascendis SOPs.
• Support central and site IRB/IEC and regulatory submissions, as needed.
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Maintains CTMS including but not limited to: site and site staff contact information, study level and site level milestones, regulatory submissions and approvals on both study and site level.
• Escalate pertinent CRA performance and site compliance issues when necessary.
• Collaborate with Director of Clinical Operations, data management and CRAs to ensure data quality and compliance with data cleaning timelines.
• Assist CRAs and sites with supply shipment/tracking, sample tracking and IMP shipment tracking and management.
• May review and approve Vendor Data Clarification Forms.
• Prioritize and escalate issues, as needed.
• May develop or assist in developing study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials).
• May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Associate Director.
• May be responsible for development, review and/or implementation of vendor documentation.
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• May meet with Associate Director, Clinical Operations on a regular basis to report deliverables, timelines and employee development.

Senior Clinical Trial Manager

Marketing

• Own the annual U.S. KOL engagement plan and congress strategy for the endocrine portfolio, including peer-to-peer education content and execution and speaker bureau strategy.
• Plan and execute KOL programs (e.g. advisory boards, speaker programs, etc.) and congress meetings in coordination with brand leads, including timely insight capture/readouts.
• Lead and develop the Thought Leader Liaison team to execute KOL and institution account plans, including goal setting, tracking, and performance feedback.
• Establish working cadence with cross-functional partners to drive execution, manage dependencies, and integrate insights into brand strategy and optimization.
• Own budget/forecasting, on-time delivery, and execution in full compliance with company policies and applicable regulatory requirements.
• Model Ascendis Pharma values through day-to-day leadership and decision-making.

Senior Director, Marketing – Key Opinion Leader Strategy and Engagement

Procurement

• The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, PV Vendor Management Team is responsible for all Vendor Management related activities.
• Pharmacovigilance related responsibilities during the initiation, conduct and closure of Organized Data Collection programs for marketed products. These activities include, but are not limited to:
• - Liaise with functional units to identify Market Research Programs, Patient Support programs and other Organized Data Collection programs
• - Ensure all programs are identified and tracked appropriately throughout the program lifecycle (initiation, conduct and closure)
• - Provide strategic input on the conduct of program to ensure compliance with PV requirements (e.g. add applicable PV language to vendor contracts, establish AE exchange method & timelines, and more)
• - Ensuring SP/vendor oversight under the guidance of Head of PV Vendor Management
• - Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
• - Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required
• - Monitoring SPs/vendors to identify areas of risk and develop strategy and action plans to ensure compliance
• - Overseeing and supporting implementation of CAPAs as necessary
• Work Closely with Ascendis GVP Compliance team and Commercial organization as required to ensure oversight of SPs/vendors.
• Oversee the vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which in includes, but is not limited to:
• - Responsible for assigned PV activities/projects and working collaboratively with other teams within Ascendis
• - Ensures that Adverse Events from Organized Data Collection programs involving Ascendis products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies. Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• - Functions as a PV advisor to Medical Affairs, Commercial Organizations and other relevant stakeholders as applicable
• - Ensures processes are adhered to that support on time and appropriate ICSR submissions
• - Provides pharmacovigilance expertise to Ascendis or Vendor staff when needed
• Additional activities may include but are not limited to:
• - Maintains strong relationships and communication with key stakeholders, including Commercial leadership, and GPS leadership to address queries, share metrics, and discuss new program-related processes
• - Through coordination with Ascendis GVP Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
• - Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
• - Work collaboratively with ICSR Management, Clinical Trial, EU QPPV and Medical Safety Science team for assigned activities
• - Implementation Coordination activities and associated tracking as necessary
• - Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head of PV Vendor Management (example: Local PV agreements, CRMs, NPP’s, Digital Media etc.)
• - Participate in relevant crisis management activities within the scope of Ascendis PV group

Senior Manager, PV Vendor Management Team

Pricing Analyst

• Serve as a senior, strategic, thought partner to U.S. Commercial teams by framing and answering high impact business questions related to brand strategy, execution, and investments
• Lead monthly business reviews, executive leadership discussion and standard planning cycle, driven by strategic analytics and insights that are aligned to brand strategy and that identify performance opportunities and optimal levers across commercial functions
• Lead cross-functional teams to deliver succinct and actionable insight summaries to drive business decisions for senior leadership, based on multiple sources of information
• Design and maintain dashboards, KPIs, and reporting tools that provide visibility into sales performance, brand health, and commercial effectiveness.
• Analyze and synthesize complex datasets to generate actionable insights that inform sales, marketing, and customer engagement strategies.
• Synthesize insights from market research into clear, compelling narratives with actionable recommendations for senior leadership
• Diagnose performance gaps and recommend optimal, data-driven actions and enhanced strategies
• Excel at storytelling to translate technical and complex findings into simple and actionable solutions
• Foster strong project management skills with experience structuring projects, directing cross-functional accountability, and driving productive meetings & timely deliverables

Associate Director, Global Regulatory Affairs Clinical Strategy

Senior Clinical Trial Manager

Senior Director, Marketing – Key Opinion Leader Strategy and Engagement

Senior Manager, PV Vendor Management Team

Director of US Insights, Commercial Analytics