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 Asc Director Clinical Safety Notification opportunity in Northbrook, IL.
Purpose & Scope:
Responsible for the oversight and maintenance of safety notification delivery systems for global clinical trials within Clinical Science & MA, where applicable. Functional management of a group of 2-6 Primary Clinical Safety Specialists and Managers (Global Development Operation Leads).
Oversee the continuous evaluation of best practices related to design methodology and execution of safety notification procedures.
Reports to the Head of Clinical Science Management Office, is a member of the Clinical Science management team and contributes to the implementation of the Clinical Science mission, Clinical Management team and Non-Project initiatives as requested, and 1-3year strategic plan.
Contributes to the continuous improvement and use of an integrated single GDO set of standards, processes and tools for the design, execution of safety notification reporting practices for clinical trials in M&D.
Responsible for the optimal development, allocation and management of Clinical Safety Notification Dept. (CSND) resources in support of APGD global project teams, extended teams and deliverables teams, respectively, for applicable therapeutic area(s).
The scope of the Clinical AD/ Clinical Safety Notification position is from portal set up through development and life cycle management for M&D projects and local development programs, as applicable.
Essential Job Responsibilities:
* Lead the evaluation and implementation of new safety reporting systems and system process plans
* Develop and implement plans to achieve compliance objectives
* Contribute to development of Global Clinical Science 1-3year strategic plan and objectives
* Contribute to creation of clinical resource estimates for CSND area, and budget management
People Management and Development
* Direct supervision of 2 - 6 individuals
*Responsible for recruitment, development / career management, and retention of staff
* Coach, develop and support Clinical Safety Specialist / Managers in providing best in class clinical science support to Astellas, and study teams
* Provide oversight and guidance to clinical team members in completing safety portal system training according to quality standards
* CSND and leading non-project initiatives as needed
Performance and Resource Management
* Manage and allocate internal and external resources to projects
* 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 training program of vendor staff in Astellas standards, processes, and systems
* 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
* Inspire individuals while holding them accountable for project and study delivery, and to provide expert clinical science input into development programs
* 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
* Ensure expert clinical science safety reporting strategy input is provided to CSLT as needed
* Perform functional management review of major deliverables and supports individuals in providing excellent clinical science input into design, execution and reporting of safety systems and deliverables
* Provide oversight on clinical safety operational matters 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 safety reporting practices and systems
* Stay at the cutting edge of safety notification methodology development in support of clinical science
* Leader or member of external industry or professional organizations; develop and maintain relations with key clinical science safety reporting 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 safety budgets, resources and timelines for clinical programs using the portal. Safety reporting budgets may exceed $2-5M. Responsible for contributing to management of department budget.
Reports to the Sr. Director, CSMO. Member of Clinical Program Management team. Functional management of a group of 2 - 6 specialists and managers.
Collaborate effectively globally with Clinical Science, MA, PV, QA and Regulatory departments.
Ability to influence peers in same function, also in other sites; influence other peers and more senior managers inside and outside of GDO on clinical safety reporting best practices.
Collaborate inside and outside of GDO - ensuring excellence in study and project teams.
- BA/BS degree with at least 10 years clinical trial management experience; advanced degree (MS, PhD, PharmD) preferred with 7years clinical trial management and clinical safety reporting experience
- Minimum of 4years people management experience
- Must have extensive expertise in developing operational strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
- Must have extensive experience in people and project management, strategic planning and a strong knowledge of protocol and clinical drug development processes, clinical study design, and safety reporting systems
- 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.