Principal Business Application Leader
Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
Principal Business Application Leader
Relocation is not designated for this position.
Objectives and Scope of Position:
The Principal Business Applications Leader (pBAL) acts as the product manager for one or more assigned business applications. The pBAL will already possess, or develop, a deep understanding of how their assigned business applications are used and proactively identify new application needs and uses. The pBAL has accountability for the business requirements along the stages of the end-to-end business application lifecycle including design, implementation and continuous improvement for one or more assigned business applications ensuring their assigned business application(s) remain fit for purpose.
She/He works closely with business customers to proactively identify and anticipate business needs. The pBAL will work with Informatics and/or other appropriate functions to realize the necessary changes in business applications to support ongoing business needs. She/He is accountable for ensuring that Clinical Operations systems effectively support the business processes and meet business needs now and in the future.
In close collaboration with key stakeholder functions/customers she/he is accountable for the identification of system related business capabilities, defines the business application strategy for Clinical Operations through a deep understanding of business and user needs, and consults with Informatics to ensure that the business systems strategy meets the ongoing needs of the business.
She/He has business oversight of the continuous system improvement process and drives the prioritization of enhancements. The pBAL works closely with business stakeholders and support functions to prioritize changes.
The pBAL is accountable for ensuring business readiness for new releases. The pBAL will ensure that appropriate communications, change management, and training activities take place for their assigned systems. The pBAL will be accountable for business readiness and adoption and coordinate activities with other functions as necessary.
For GxP systems, the Principal BAL may be accountable to maintain the CSV status by assuming the CSV Process Owner role.
For systems with high business importance and high impact the Principal BAL may be supported by a BAL. In this case the split of accountabilities will be agreed.
For non-PDG owned systems she/he may represent PDG in the appropriate systems governance bodies.
Primary Responsibilities and Accountabilities:
Business System Product Manager
- Acts as the product manager for assigned business applications.
Maintains internal knowledge of how systems are being used and recommends appropriate upgrades/changes based on user/customer needs.
Understands upcoming business trends that may require changes to business applications and proactively creates and champions plans to bring the necessary changes to the business.
Understands the external landscape. Knows what applications are being used by competitors and how they are being used. Makes appropriate recommendations for application changes/upgrades based on market knowledge.
Understands external technology trends and partners with appropriate functions to evaluate and recommend new applications, technologies, etc. to support business needs.
Roadmap & Planning
- Builds and maintains deep functional knowledge of the overall clinical operations system & information landscape for the supported clinical operations business processes
- Accountable for identifying and rationalizing Business Capabilities across clinical operations (people, process, capability & priority)
- Contributes to the creation and maintenance of the overall clinical operations business systems strategy.
- Collaborates with and supports other functions as appropriate in the creation of the business system strategy
- Accountable to approve the business requirements and scope of the system changes
- Partners with IT to establish strategic vendor relationships
- Collaborates closely with key system stakeholders and customers in clinical operations to proactively identify areas for improvements and anticipate future business needs for assigned business applications
Continuous systems improvements / Business Operations / System Delivery
- Prioritizes requested system changes based on business importance
- Serves as the Business System Subject Matter Expert on projects and may assume the Business Sponsor role for system implementation or improvement projects
- Accountable to establish an effective operational system governance
- Chairs System Change Control Board which is responsible for confirming prioritization and approval of requested changes and proposed release.
- Prioritizing and/or rationalizing changes/enhancements across stakeholders
- Accountable to maintain the validation status according to Roche CSV guidelines for GxP applications and can assume CSV Process Owner accountability
- Supports the conduct of internal audits and regulatory inspections and supports the implementation of system related CAPA implementations
- May coordinate business activities for system enhancements managed within operations. This can include coordination of
- User Acceptance Testing
- Support Readiness
- Training Readiness
- Change and Communications
Who You Are
- Bachelor’s Degree preferred. Advanced Degree in related field is a plus
Product management experience preferred
- 12 - 15 years’ experience working in Clinical Operations and Business System Management
- ISPMA (International Software Product Management Association) certification is a plus
- Extensive understanding of the systems “product” lifecycle. Ability to interpret and articulate business needs to technical designers. Proactively surveys the customer market and provides proactive direction to technical staff for the design, upgrade, and implementation of business systems.
- In-depth knowledge of Clinical operations systems and processes, excellent understanding of the clinical operations system landscape
- Extensive experience with systems improvements and systems integrations in support of business processes
- Good understanding of Software development processes along all stages of the software product lifecycle
- Extensive experience in defining requirements/specifications and user acceptance testing for computer systems
- Extensive experience working in a global cross-functional team (matrix) environment
- Proven track record of successful partnership & collaboration with key stakeholders and business partners
- Extensive experience of influencing and negotiating at all levels to achieve delivery
- Fluent English language skills
The specific experience will be required
- Experience of working in a laboratory environment
- Experience and detailed knowledge of Laboratory Information Management systems
- Experience and understanding of sample management processes and supporting instruments and systems
Competencies & skills
- “Systems thinking” and in-depth understanding of how computer systems support business process/needs
- Outstanding leadership skills developed through leading successful global multi-functional and/or matrix teams and stakeholder/business partner interactions
- Superior stakeholder management ability: works, communicates and partners with key stakeholders and business partners, both internally and externally
- Has deep knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical development, regulatory, etc.
- Drives the application of strategies and concepts and determines best course of action
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing cost, time and longer-term objectives.
- Manages diverse range of tasks and develops solutions to complex problems where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact. Regularly uses ingenuity and innovation within this process
- Self-motivated, self-starter and achievement driven, works without appreciable supervision
- Excellent time management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
- Good understanding of international regulations, processes and issues in drug development.
- Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes
- Excellent written and verbal communications and interpersonal skills; can influence without authority
- Demonstrates Roche Values & Leadership Competencies
Other (e.g., Travel)
- National and international travel: Approximately up to 20%
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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