Associate Director, Development Operations Project Management

Company: Ascendis Pharma
Location: Palo Alto
Posted on: January 16, 2022

Job Description:

Associate Director, Development Operations Project Management Palo Alto, California, United States Development Operations, Business Planning and Optimization Full time The successful candidate will be a self-motivated Project Manager in Development Operations, who is responsible to lead the clinical sub-teams in the implementation and execution of the development strategies on the clinical development projects and for supporting clinical study and regulatory filing activities, timelines, and deliverables with a clear understanding of functional interdependencies and critical paths. The Project Manager will be responsible for supporting various development projects and functional areas in Development Operations and accountable for communicating project status and issues to ensure the milestones and deliverables are met. The Project Manager will report to the Director of Project Management Development Operations.

Key Responsibilities

• Responsible for execution and oversight of the clinical development strategy as it relates to clinical and regulatory activities in Development Operations.
• Manage the clinical program's overall process and schedule for all relevant clinical studies (Phase 1-3) and regulatory filings in collaboration with key functional stakeholders across the company.
• Organize and facilitate clinical and regulatory sub-team meetings to drive, track and mitigate risks, report and resolve issues, review action items, and document decisions in the execution of clinical trials and regulatory filings.
• Supports the clinical and regulatory sub-team teams in project planning, including timelines, budget, and resource management.
• Supports the Program core team and clinical and regulatory sub-teams by facilitating sub-team meetings to move development projects forward.
• Communicate project status and issues within Development Operations or other functions to ensure milestones and deliverables are met.
• Provide regular status update to senior management in Development Operations
• Proactively assess and escalate risks/issues impacting the conduct of the trials, timelines, the management of the clinical data and regulatory filings.
• Leads and contributes to project improvements and efficiencies in Development Operations' initiatives & programs such as identifying areas of best practice, process improvements, development of SOPs & Wls, department level trainings.
• Foster and cultivates strong interdepartmental collaboration, including facilitation of best practices and lessons learned sharing with all internal and external stakeholders affected by the project including project team, management team, end users, governmental/regulatory agencies, and vendors. Requirements
  • BA/BS or equivalent degree in scientific discipline with 10 years of clinical trials research experience/clinical/regulatory project management in a pharmaceutical /biotechnology company.
  • Demonstrate understanding of clinical trials processes from study start-up through study closure (e.g., clinical operation, data management, safety, biostatistics, medical writing, regulatory filings).
  • Ability to coordinate with and influence internal and external stakeholders to facilitate the advancement of projects at all stages.
  • Ability to support multiple project teams simultaneously; be well organized and have strong time management skills and attention to detail.
  • Ability to work under limited supervision, determine personal work plan, schedule tasks and activities accordingly.
  • Demonstrate excellent communication skills and prove as an effective team player.
  • Ability to manage the projects with sense of urgency and driven by project targets/milestones.
  • Exceptional ability to manage changing priorities and ambiguity.
  • Basic knowledge and skill with software to track the project status and timeline, such as Microsoft Excel, Microsoft Project and other tracking tools.
  • Ability to work odd hours and potentially travel up to 10% of the time domestically and internationally. Ascendis Pharma collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the privacy notice for further details. If you are a California Job Applicant see the privacy notice for further details. Ascendis Pharma is proud to be an equal opportunity workplace and we believe that diversity and inclusion among our workforce is critical to our success as a global company. Individuals seeking employment at Ascendis Pharma are considered without regards to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. All employment is decided on the basis of qualifications, merit and business need.

Keywords: Ascendis Pharma, Palo Alto , Associate Director, Development Operations Project Management, Executive , Palo Alto, California