Senior Manager, Operational Excellence - Global Development Operations
General Position Overview:
The Global Development Operations (GDO) Operational Excellence (OE) Sr. Manager is responsible for identifying, facilitating and managing continuous process simplification and optimization initiatives across Clinical Operations (both US and ex-US) in close collaboration and consultation with the business and under guidance of the Sr Director of Operational Excellence. The role will report into the Senior Director of Operational Excellence and will be particularly focused on ensuring the successful implementation and execution of GDO specific business processes, standards and trainings associated with CA PPM. The OE Sr. Mgr position will be leading and co-leading multiple initiatives that will aim to transform CA PPM into a single source of truth for Clinical Study Timelines , Financial OOP Costs & Budgets for Clinical Studies , Resource Demand, Capacity, Scenario Planning & Allocations for Clinical Studies. The ideal candidate will take initiative and show strong cross-functional facilitation and leadership skills to continuously drive improvement and ensure the Ways We Work values are integrated throughout GDO's culture. Project management and clinical study management experience, including knowledge of Project and Portfolio Management (PPM) tools, is required.
Key Accountabilities/Core Job Responsibilities:
- Manage GDO specific business processes, standards and trainings associated with CA PPM, Pharmacyclics Project and Portfolio Management system (CA PPM).
- Serve as GDO CA PPM subject matter expert (SME), partnering with Clinical Operations leadership team, clinical trial leads (CTLs), clinical information systems (CIS), IT, external vendors and other departments as needed to drive consistency, transparency and simplification efforts.
- Partner with Clinical Operations and Study Management Teams (SMT) to drive implementation of automated GDO project status reporting.
- Manage monthly reporting activities, ensuring accurate communication and reporting of information on clinical study status, changes, risks and issues to study teams, internal and external stakeholders, and Senior Management.
- Function as a Clin Ops planning SME, providing input into the implementation of GDO's resource planning calculators, demand & scenario planning.
- Provide input/expertise into the development and deployment of a snapshot capability for key assumptions, projected enrollment, patient drop-off & site activation in CA PPM.
- Assist with the implementation of GDO resource management activities in CA PPM.
- Manage GDO's resource planning activities in CA PPM.
- Assist with creation and deployment of both internal and external Operational Excellence Sharepoint sites, ensuring efficient management of all Operational Excellence related efforts.
- Establish key working relationships with other GDO senior leaders to develop and maintain as a core strategic imperative for the department a continued focus on process simplification and optimization through operational excellence.
- Assists with education, training, and mentoring of GDO clinical operations personnel.
- Collaborates and assists with any other process simplification and optimization initiatives taken by the Operational Excellence team as needed.
- Minimum of 8 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years of direct project management experience in drug development)Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
- Must have considerable experience managing and overseeing clinical trials
- Excellent communication (oral and written), judgment, interpersonal and problem-solving skills
- Hands-on ability to think strategically and tactically
- Intense drive and organizational expertise are necessary to manage the diverse group of functional activities
- Entrepreneurial spirit with can do attitude, commitment to teamwork and initiative
- Knowledge and experience with managing complex clinical development situations
- Proficiency in monitoring budgets and overseeing expenditures
- Demonstrated ability to lead teams or task forces in the development of Development Operations processes, plans and tools
- Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
- Proficiency in MS Word, Excel, PowerPoint, SharePoint and Project Management Tools
Education and Experience Requirements:
- 8 (Sr. Manager) years of experience in the pharmaceutical industry in a variety of roles associated with drug development (research and development, commercial, project management, operations)
- Minimum of 2 years leading drug development teams as a cross-functional project manager
- Oncology experience is preferred
- Experience with Project and Portfolio Management (PPM) system such as CA PPM, Microsoft Project Server, Planisware or equivalent required
- Experience overseeing implementation and/or administration of PPM system preferred
- Advanced degree is preferred (e.g. MS, PhD, MBA) or commensurate experience
- Broad knowledge of program management practices in the pharmaceutical industry
On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.