Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and biomarker driven drug development in areas of high unmet medical need.
The EU Liaison, Associate Director (AD) is a leadership position within Denali’s Clinical Operations team. The AD is accountable for leading clinical operations programs in the EU as they apply to US based programs. The EU liaison will be building relationships with EU Investigators, clinical sites, patient advocacy groups and vendors. This position is based in Zurich, Switzerland and reports into the Head of Clinical Operations based in South San Francisco, California USA.
Responsible for the program leadership and EU operational strategy for one or more molecules.
Acts as the clinical operation’s team representative in the EU and collaborates with cross-functional team members including clinical operations, regulatory, clinical science etc.
Assess pipeline to determine current and future needs for Investigators, sites, patient advocacy groups, and vendors.
Identifies and cultivates relationships with Investigators and site personnel. Creates a team of high functioning clinical sites experienced in Neurology and Rare Disease.
Assists with identification of potential advisory board members and helps plan advisory board meetings in the EU.
In partnership with the Denali Patient Advocacy Lead, participate in the introduction and relationship management of PAGs in the EU.
Collaborates closely with colleagues in the EU to help define an EU strategy to regulatory and clinical trial needs.
In partnership with clinical outsourcing, participate in the identification and selection of clinical operations vendors. Increases Denali’s presence and makes Denali’s business needs clear to EU based vendors. Point of escalation for any issues, liaising with the study team.
Builds relationships with vendor personnel to foster a high level of performance from each vendor and quick resolution of issues related to clinical trials or vendor performance.
Represents Denali Clinical Operations at conferences and assists in conference identification.
May manage direct reports including performance management and professional development planning for team members.
May be accountable for clinical operations planning and implementation of clinical development program including scenario planning, forecasting of timelines, assessment program level feasibility, estimation of resources and budget, and development of operational strategies.
Responsible for developing department EU specific (as needed) processes in partnership with Denali Quality Assurance to ensure adherence to DENALI’s standards, and all applicable regulations and guidelines.
Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations.
Contribute and facilitate the development of standard clinical trial management plans and tools.
Contribute and facilitate Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities.
Oversee clinical site and sponsor GCP inspection preparation and support activities.
All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
Bachelor’s degree required. RN/PA with professional clinical experience, and/or Master’s degree or higher in health-related science or equivalent preferred.
More than 10 years of experience managing Phase 1-4 clinical trials, both domestically and internationally.
Experience managing direct reports.
Excellent organizational skills and attention to detail.
Effective communication and interpersonal skills.
Ability to efficiently perform multiple tasks and manage changing priorities.
Ability to identify and solve logistical problems.
Ability to travel in the EU approximately 30-50 % of the time.
Ability to travel to Denali on a quarterly basis.
Willingness to manage to Pacific Standard time when necessary.
Fit with Denali
Ability to build strong relationships with co-workers of various backgrounds and expertise.
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
Values-based leadership consistent with Denali's Core Values.