Associate Director, Clinical Operations - Oncology

Company: Ascendis Pharma
Location: Palo Alto
Posted on: September 23, 2022

Job Description:

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 or may be remote and reports to the 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.Requirements
  • Bachelors degree or masters 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 lawBenefits
    • Medical insurance
    • Vision insurance
    • Dental insurance
    • 401(k)
    • Paid maternity leave
    • Paid paternity leave
    • Commuter benefits
    • Disability insurance

Keywords: Ascendis Pharma, Palo Alto , Associate Director, Clinical Operations - Oncology, Executive , Palo Alto, California