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Responsible for development and maintenance of excellence in the strategic planning and conduct of clinical trials expertise in APGD, and for the successful application of this expertise globally (EU and US) to all phases of drug development in all Astellas' therapeutic areas of focus.
Reports to the head of Global Development Operations, is a member of GDO senior leadership team and participates in the creation and execution of GDO mission, objectives and 3-5 year strategic plan. Also participates in the creation and use of an integrated single GDO set of standards, processes and tools for the design, execution and reporting of clinical trials in APGD.
Responsible for the optimal development, allocation and management globally (EU and US) of Clinical Science resources fulfilling roles that include Global Development Operations Lead, Study management, Site management and Clinical trials support to APGD global project teams, extended teams and deliverables teams, respectively.
Responsible for the development and maintenance of Clinical Science specific global standards, processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies.
Effectively collaborates with Group TAHs and TAHs to ensure 1) Therapeutic area specific best-in-class knowledge, application, and molecule strategic context is successfully reflected in the operational strategies and execution of clinical development programs; 2) that Clinical Science resources and deliverables meet and exceed their expectations of context, project team participation and behavior, quality and timeliness of deliverables; 3) optimal review and management of Clinical Science input at project review governance; and 4) appropriate training and sharing of specific therapeutic knowledge and innovation.
Effectively collaborates with Regulatory Affairs to ensure optimal quality, timeliness and coordination of the preparation and submission of relevant regulatory dossiers, documents and specialty publications.
Effectively collaborates with Product Safety and Pharmacovigilance to ensure optimal development of standards and process for the collection and communication of human safety information, ensuring safety of all patients receiving investigational and or marketed Astellas products.
Effectively collaborates with CP and DDR to ensure optimal standards, knowledge and processes to enable translation and incorporation of non human and early development information into clinical development strategies, plans and clinical trials; and to ensure development and compliance with common standards and processes for the execution of clinical trials conducted by CP.
Develop and implement 3-5 year Clinical Science-specific mission, strategic objectives and plan
Develop and maintain competency framework, training programs, and attract and retain best in class Clinical Operations expertise in the Clinical Science function at Astellas.
Develop and implement optimal organizational structure which maximizes on the use of resources globally and reflects the therapeutic area focus in APGD.
Develop an environment to enables each member of Clinical Science to optimally operate in the matrix environment of Drug Development in APGD
Develop and implement Clinical Science-specific optimized processes and ensure alignment of these processes with other intra and cross functional processes that enable optimal drug development and support at Astellas.
Ensure alignment with other GDO functions, TAHs, Pharmacovigilance, Regulatory Affairs, CP and Medical Affairs in the development of clinical development, protocol, CSR, ISS and ISE standards and processes.
Develop and implement processes for the growth, health and support of the Clinical Science Function and resources including HR, financial, information solutions and administrative support.
Develop and maintain strategies and systems, in collaboration with other GDO and APGD functions and APGD IT to enable the successful planning and conduct of APGD clinical Trials.
Develop and implement resource algorithms and performance goals by role. Ensure optimal planning and allocation of internal resources. Develop and maintain optimal solutions for functional service provider relationships with appropriate quality and oversight to ensure flexibility and agility in the allocation and management of internal and external resources.
Accountable for the development and implementation quality control of Clinical Science competencies for both internal and external resources.
Accountable for compliance by the Clinical Science function with Astellas policies and procedures, and specifically health care compliance.
Responsible for collaborations with other functions in Development including clinical Quality Assurance to develop and implement Quality programs.
Functional leadership of the Clinical Science function globally (EU and US) with 4-5 direct reports, namely the global heads of Clinical Program Management, Study Management, Site Management and Clinical Trial Support.
Accountable for recruitment, performance management, standards and training, financials and resource planning and allocation.
Responsible for ensuring appropriate HR, Finance, IT and facilities planning support and administration.
Responsible for ensuring optimal use of resources and appropriate vendor relationships.
Accountable for developing and ensuring a positive culture, optimal communications and ability of staff to operate in a cross-functional matrix and for the development and maintenance of effective collaborations with internal key stakeholders and functions, as well as the selection and oversight with GPA of relevant external vendors.
With TAHs, ensures common knowledge platform by therapeutic area and molecule, performance management process for GDOL and Study Manager Role.
With other GDO senior leaders, participate in the development and implementation of GDO specific strategies.
With GPA, GPM and GIT ensure alignment with resources, budget, roles and processes associated with project planning and management.
With Clinical Pharmacology, ensure alignment at level of CDP design and content quality, role of study manager for phase I and POC trials.
With Commercial and Medical Affairs partners determine appropriate operational feasibility and design of early and late phase studies to incorporate health outcomes, population modeling, etc.
Minimally a BS Degree. Must have at least 15 years of pharmaceutical industry experience specifically in human drug development, and at least 3-5 years managing managers of multiple groups within the area of Clinical Operations/Clinical Science. Previous experience in leading a Global Clinical Operations function is preferable. Must have a successful track record in the hiring and retention of excellent clinical operations resources globally, who work optimally in a cross functional team and matrix environment. Must have a successful track record in effectively collaborating with other functions in development, discovery research, Medical Affairs and Commercial in the development and support of medicines.
Displays the highest level of personal commitment to the Astellas code of Ethics. Is exemplary in ensuring that 'every employee deserves a great manager'. Inspires while holds all appropriately accountable. Commits through co-accountability, to the growth and health of GDO, APGD and Astellas.
Must have an in-depth personal experience and understanding of the Clinical Science function and the critical contribution of Clinical Operations to drug development, Must also have an understanding of the functions of multiple business units throughout the company, and have maintained effective collaborations with leadership of those business units and functions. Is considered an industry expert and is able to recognize the implications of new directions, trends and developments globally and on a multi-country and regional level, in site and patient recruitment, site monitoring, essential document collection and management, and the optimal use of cross functional outsourcing relationships.
Must be a strong and effective strategic thinker and problem solver, requiring the ability to both recognize and anticipate problems, and also help managers and individuals develop their own problem solving skills and discipline. However, must also be able to identify and solve tactical problems and delve into high degree of detail when necessary. Plans for and has detailed knowledge of all available resources internally and externally, has developed the appropriate relationships with partners and vendors, and has the ability to marshal those resources in a productive and efficient manner, either as part of a 3 year strategic capacity plan, or when there is need for sudden and immediate change in direction.
Is accountable to the head of GDO, and to APGD for excellence in the Clinical Science standards, resources and overall performance of the function.
Manages the Clinical Science function comprising Program Management, Study Management, Site Management and Clinical Trial Support/Document Management groups and its people, through successful recruitment and retention of a high performing team of managers, and individual contributors. Effectively delegates the responsibility for development and deployment of resources, while ensuring optimal oversight and supervision to ensure technical, leadership and team membership skills are maintained.