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Astellas is announcing a Sr. Manager/Associate Director, Clinical Studies opportunity in our Deerfield, IL location.

This position will serve as a Global Development Operations Lead within the clinical studies group.

SUMMARY:

Responsible for overseeing the management of multiple clinical development programs that typically involve multiple therapeutic areas or indications. Provides direction to Senior Managers and Study Managers and clinical teams Assures quality of key study team deliverables, including protocols, study reports, IND and NDA documents. Involved in strategic planning, lifecycle management and new product evaluations of assigned compounds. Acknowledged resource for project teams in assigned therapeutic areas. Effectively interacts with FDA and other regulatory authorities. Acknowledged resource for project teams in GCP and ICH regulations, drug development and clinical trial management. Leadership role in development and implementation of process improvement initiatives. Active role in management of Clinical Studies group. Anticipates and plans for human resource needs. Responsible for management of direct reports and staff who report to direct reports.

POSITION DUTIES:
Organization. Anticipates and plans for human resource needs within assigned areas; organizes clinical staff for maximum effectiveness in meeting business needs; sets goals, timelines and priorities; and establishes appropriate course of action for assigned projects; provides direction, leadership and learning opportunities to enhance development of subordinates. Prepares annual performance objectives, performance appraisals and personal development plans for direct reports. Assures consistency in objectives and performance appraisals and implementation of personal development plans for those who report to direct reports.

Management. Plays active role in the management of the Clinical Studies Group; member of the Clinical Directors Management Committee. Assists in the development of short and long-term objectives for the Clinical Studies group. Provides oversight and direction to Senior Managers and Managers of assigned clinical programs. Provides oversight in making site selection decisions; reviews and monitors study status, including enrollment, site performance and safety of the drug. Provides oversight into preparation of key study team deliverables; Provides oversight on conduct of expert meetings, investigator meetings and CRA/CRO meetings. Effectively interacts with FDA and other regulatory authorities. Acknowledged resource for project teams in assigned therapeutic areas, GCP and ICH regulations, drug development and clinical trial management. Supports Clinical organization as a consultant on development and operational issues. Participates in global clinical research management initiatives.

Strategic Planning: Leadership role in preparation and review of clinical development plan with an emphasis on strategic planning for assigned therapeutic areas. Participates as Clinical representative on new product evaluations. Participates in project reviews at the Local Project Team and Global Project Team. Expected to demonstrate in-depth knowledge of assigned compounds and therapeutic areas.
Vendor Management. Provides oversight to study teams in the selection and ongoing assessment of CROs, including central laboratories, core ECG readers, patient recruitment vendors, etc. Works closely with Managers and CRO management in overseeing CRO staff in their study conduct including study implementation, study management and data management.

Budget Management: Oversees review and approval of study budgets, including site and CRO budgets; actively monitors study expenditures and payments. Approves or designates approval of study site and vendor payments, as appropriate.

Document Preparation: Oversees the preparation of study protocols. Provides substantive input into the preparation of clinical study reports and relevant sections of pre-IND briefing documents, INDs, NDAs and other documents intended for regulatory submission.

Good Clinical Practices (GCPs) and SOPs: Ensures that standard operating procedures for the conduct of clinical studies are followed and assesses compliance on a regular basis. Assures study site and monitoring team compliance with GCPs and ICH Guidelines.

Presentations/Publications: Presents aspects of assigned study at Investigator and Coordinator meetings; presents study status and results to senior management of the Company. Attends professional meetings and makes presentations as appropriate. Takes leadership role, or designates, to assure publication of study results in appropriate journals and presentation at appropriate scientific meetings.

Training: Takes leadership role in identifying and implementing training activities for Clinical Studies staff; may be involved in R&D and corporate training activities. Assures implementation of appropriate training for study teams, which may include CRO staff and site personnel.

Process Improvement Initiatives: Takes leadership role to develop initiatives that will improve the overall management of clinical development and Clinical Studies personnel. Participates in global clinical research management initiatives.
 

Position Requirements  B.S./B.A. life sciences degree or B.S.N or R.N. and ten years clinical research experience with four years experience in the management of people; M.S. degree and seven years related clinical research experience with four years people management experience; Pharm. D. or Ph.D. degree and five years of clinical research experience and a minimum of four years managing people. Must have excellent interpersonal skills, written and verbal communication skills, administrative skills and computer ability as well as in depth knowledge of the clinical drug development process and clinical study design and planning. He/she must be able to rapidly grasp medical concepts in a variety of therapeutic areas. Experience in project management and strategic planning is preferred. Ideal candidate will have managed a project leading to a New Drug Application or Product License Application. Candidate must also have proven management and leadership ability, knowledge of FDA/GCP requirements and familiarity with the pharmaceutical industry. Moderate (20-40%) travel required.

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