Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Associate Director Clinical Patient Experience opportunity in Northbrook, IL.
Purpose & Scope of Position:
The Associate Director of Clinical Patient Experience is responsible for the development, communication, and maintenance of patient centered approaches and capabilities for broader implementation in Clinical Science to support the overall corporate strategy of patient focused drug development. Key Job responsibilities include:
- Responsible for leading Clinical Science and cross-functional representative teams to create, maintain, and continuously optimize a framework for incorporating patient voice into global development programs.
- Responsible for leading Clinical Science and cross-functional representative teams to create, maintain, and continuously optimize a framework to improve the patient (caregiver) awareness and experience in Development sponsored clinical trials.
- Responsible for the development, communication, and maintenance of a patient centricity playbook/toolkit for use across global development projects/studies
- Responsible for ensuring patient centered strategies are congruent with best industry practices and applicable global regulatory requirements along with alignment with internal stakeholders and global non-drug product initiatives.
Reports to Clinical Program Management Director and is a member of the Clinical Science management team. Contributes to the implementation of the Clinical Science mission, Clinical Management team and Non-Project initiatives as requested, and the1-3year strategic plan.
Essential Job Responsibilities:
- Lead the evaluation and implementation of patient centered global clinical trial capabilities
- Partner with key functional areas to implement patient centered strategies in a quality, efficient and globally scalable manner
- Develop, implement, and maintain appropriate internal businesses processes to support patient centered methodologies into Clinical Science studies
- Develop and implement strategies to collect metrics to measure effectiveness of patient centered capabilities as it relates to cost, quality, and timelines
- Contribute to development of Global Clinical Science 1-3year strategic plan and objectives
- Contribute to creation of resource estimates and budget management
People Management and Development
- Provide oversight and guidance to clinical team members in implementing patient centered strategies on their clinical studies
- Lead patient centric non-project initiatives
Performance and Resource Management
- Measure and monitor compliance performance standards
- Oversee adherence to timelines, standards, processes for work assigned to their members of staff
- Review availability of sufficiently qualified vendor resources on a regular basis, contributes to planning of future vendor resource needs
- Manage any required training of vendor staff on Astellas standards, processes, and or data requirements
- Oversight of vendors, manage metrics system such that deliverables are available on time according to Astellas standards and quality requirements
- Contribute to the development and implementation of quality programs and quality standards, including the ability to effectively monitor performance
- Oversee adherence to quality standards for work assigned to their members of staff
- Responsible for compliance of direct reports with Astellas policies and procedures
- Strategic thinker and problem solver, who recognizes, anticipates and solves problems; helps individuals to develop problem solving skills. Must be able to delve into high degree of detail when necessary
- Proactively seek and leverage opportunities to understand and communicate internal and external changes as it relates to patient focused drug development.
- Ensure expert input on patient focused drug development strategies is provided to CSLT as needed
- Contribute meaningful input into data/systems related discussions that support patient centered clinical trial strategies
- Perform functional management review of major deliverables and supports individuals in providing excellent clinical science input into design, execution and implementation of patient focused clinical trial deliverables
- Provide oversight on patient centered drug clinical trial strategies for meetings with regulatory authorities, key opinion leaders and similar experts and bodies
- Encourage and support individuals in investigating and applying clinical best practice methodologies in patient centric clinical trials
- Stay at the cutting edge of patient focused drug development in support of Clinical Science
- Leader or member of external industry or professional organizations; develop and maintain relations with key patient centered drug development experts.
- Contribute to development and implementation of best in class standards, processes and SOPs in clinical science
- Leads strategic improvement projects
Responsible for overseeing the preparation and management of budgets, resources and timelines for implementation and ongoing use of patient centered capabilities within Clinical Science. Budgets may exceed $2-5M. Responsible for contributing to management of department budget.
Reports to the Director or above, Clinical Science. Member of Clinical Program Management management team. Collaborate effectively globally with Clinical Science, Japan Asia Clinical Development, Medical Science, Data Science, Legal, QA, Regulatory, and IT departments. Ability to influence peers in same function, also in other sites; influence other peers and more senior managers inside and outside of development on patient centric best practices. Collaborate inside and outside of development - ensuring excellence in study and project teams.
Requirements Required Qualifications:
- BA/BS degree with 8-10 years clinical trial related management experience; advanced degree (MS, PhD, PharmD) preferred with 7years clinical trial related management and patient focused clinical trial or clinical trialrecruitment related experience
- Must have extensive expertise in developing operational strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
- Must have experience in people and project management, strategic planning and a strong knowledge of protocol and clinical drug development processes, clinical study execution/design.
- Must have experience working across multiple phases of global development.
- Must have proven and effective interpersonal, leadership, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English; low to moderate (5% to 20%) travelrequired.
- This is a Northbrook based position