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 a Director, Clinical Program Management opportunity in Northbrook, IL
Purpose & Scope:
Accountable for the execution of assigned projects. May participate in core teams as Clinical Science representative (Global Development Operation Leads), but can designate to AD, Clinical Program Management as appropriate.
Oversees and manages Clinical Program Managers and Clinical Study Managers. This includes accountability for assuring strategic input and insight into the Clinical Development Plans (CDP) for programs including those of direct reports who are participating as core team members.
Functional management of up to 15 direct and second level reports and may sit on the Clinical Science Leadership Team (CS-LT) which is responsible for establishing the standards and operational excellence including quality and consistency across CS.
Participates in global/local drug-product and non-drug product initiatives as a Clinical Science representative.
Represents CS in due diligence activities for compounds/programs which may be in-licensed or acquired. Expectations includes the working with the DD team to design clinical development program including timelines and budgets to support registration.
Essential Job Responsibilities:
- Participate in development of Project, Study and Departmental Objectives and Plans
- Develop and implement plans to achieve objective
- Accountable for the effective oversight and execution of Clinical Development Plans for compounds assigned.
- May participate in the CS-LT which oversees CS to assure consistency, quality, operational excellence and delivery of projects
- Oversees creation of clinical program budgets and resource estimates for functional area, provide oversight of budget and resources, and contribute to the management of the entire Global Clinical Science budget
- Participates in resource allocation across CS as requested
- 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
- Recognized as an expert in clinical study execution by other functional areas who contribute to the delivery of studies
- Supports implementation of departmental initiatives and serves as a change management champion for CS
People Management and Development
- Direct supervision of up to 10 - 15 direct and second-level reports
- Responsible for recruitment, development / career management and retention of staff
- As needed, provide oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards
- 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 programs assigned to their staff
- Responsible for compliance of direct reports with Astellas policies and procedures
- Provide input into annual audit plan and ensure proper follow up on Corrective and Preventative Actions in response to auditreports issued by Clinical QA.
- Ensure expert clinical science strategy input is provided to Core Teams
- Provide oversight, directly or indirectly, on clinical 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 drug development programs
- Stay at the cutting edge of methodology development in clinical science
- Contribute to development and implementation of best in class standards, processes and SOPs in clinical science
- Leads strategic improvement projects or initiatives as requested
Responsible for overseeing the preparation and management of budgets, resources and timelines for multiple clinical programs. Program budgets may exceed $500M. Responsible for contributing to management of department budget.
Report to Sr. Director, Clinical Program Management or above. Responsible for management of up to 15 direct and second level reports.
- BA/BS degree with at least 12years of clinical trial management experience; advance degreepreferred (MS/PhD/PharmD) with at least 8years clinical trial management experience
- Minimum of 6years of direct people management experience
- Demonstrated leadership skills and ability to effectively collaborate with colleagues in CS to deliver portfolio of work whether within or outside your programs
- Demonstrated ability to successfully identify and lead global process or system improvement initiatives
- Must have a strong knowledge of clinical development processes and conducting global clinical programs
- Must have experience working across multiple phases of development and in multiple therapeutic areas
- Must have proven leadership skills and effective written and verbal communication skills.
- Fluent in English
- Moderate (up to 25%) travelrequired, depending upon assigned program and phase.