Associate Director, Clinical Operations, Oncology - Job ID: 1171

Ascendis Pharma

Ascendis Pharma

Palo Alto, CA, USA
Posted on Sunday, July 9, 2023

The Associate Director (AD) is responsible for effective conduct of Ascendis’ global and regional clinical trials. As a key member of the cross-functional team driving Ascendis’ clinical trials to completion according to agreed timelines and quality, the AD / Sr. CTM contributes directly to Ascendis’ focus on making a meaningful difference in patients’ lives and is part of a global organization with locations in US, Germany, and Denmark. The role is based in Palo Alto, CA and reports to the Sr. Director of Clinical Operations Oncology.

Key Responsibilities

  • Chair internal clinical trial teams with representation from relevant functional areas.
  • Contribute to clinical trial protocols in collaboration with the Medical Monitor or Clinical Scientist.
  • Coordinate and drive identification, assessment, and selection of relevant CROs and vendors; for example, central and special laboratories and imaging service providers.
  • Successfully manage and own clinical site and investigator relationships.
  • Review monitoring reports for compliance to study protocols and GCP.
  • Manage, track and oversee clinical site budgets/payments in relation to conduct of a clinical trial.
  • Participate in identification, qualification, initiation and close-out of clinical trial sites.
  • Develop or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
  • Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
  • Manage and oversee contracted CROs and vendors; identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics.
  • Plan and participate in Monitor and Investigator Meetings.
  • Review protocol deviations and data listings.
  • Support IRB/IEC and regulatory submissions, as needed.
  • Communicate directly with trial site staff and investigators to support the relationship between the sponsor, CRO, and site, including co-monitoring or monitoring / Sponsor oversight visits.
  • Support safety reporting.
  • Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
  • Participate in project core team meetings as appropriate.
  • Contribute to Ascendis’ Clinical Quality Management System by authoring or contributing to clinical SOPs.
  • Oversee junior team member deliverables as needed.
  • Associate Director may perform line management for 1 – 2 team members, depending on experience.

  • Bachelor’s degree or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
  • Ability to work across global time zones (including EU, APAC)
  • High proficiency in English with strong communication and presentation skills
  • Possibility to travel up to 20-30% of the time domestically & internationally
  • Associate Director role requires minimum 8-10 years of industry experience, including a minimum of 2 years of oncology clinical trial experience. Global clinical trial experience preferred.
  • Experience working in a cross-functional matrix environment, CRO management and oversight, and managing and overseeing vendors
  • Experience in performing monitoring oversight visits, including remote visits, desired
  • Ability to prioritize and to work independently on assigned tasks, manage timelines, and to present ideas to sites / stakeholders clearly and effectively
  • Computer skills: Excel, PowerPoint, MS Word, Medidata RAVE
  • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
  • Estimated salary: $190-205K/year
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance