Job description

Palo Alto, California, United StatesClinical Development OncologyFull time962MRG

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.
Estimated salary: 180-1905K/year
Requirements

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
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance

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