Job Title : Principal Clinical Innovation and Technology LeaderLocation : Remote in San Francisco, CA+3 locationsCompany : GenentechSalary : Open Date : 2023-01-30Close Date : 2023-05-30The Position
BACKGROUND:
US Medical Affairs (USMA) is part of Genentech’s CMG (Commercial, Medical, Government) organization, and is focused on leading the healthcare industry by improving patient outcomes and the customer experience. USMA includes its own Evidence Generation (EG) function that is focused on delivering tomorrow’s medical advances faster to more patients via clinical trials of the future, cutting- edge insights generation, and groundbreaking inclusive research. USMA EG has end-to-end expertise across the data and insights generation value chain including biostatistics, data sciences, clinical operations, data management, biosample management, and systems and vendor management. USMA EG manages a data generation portfolio of over 500 clinical trials including company-sponsored and supported trials and an insights generation portfolio of over 200 projects including exploratory data analyses, real world data and personalized health care projects.
POSITION OVERVIEW:
The Clinical Innovation and Technology Leader (CITL) is an individual contributor who reports to a Systems, Vendors, and Biosamples Leader (SVBL). The CITL, SVBL, and other colleagues work within a cross functional EG cluster that is led by an EG Leader (EGL). Each EG cluster collaborates with key stakeholders including USMA Medical Partner(s), Chief Medical Partner(s), CMG Squad(s), and relevant colleagues in Global Clinical Operations (PDG) and Global Biometrics (PDB), gRED, and pRED as applicable, to develop the USMA data and insights generation strategy as part of the USMA Strategic Medical Plan (SMP), and to execute clinical trials, studies, and projects, and/or manage systems, service providers, and data. The CITL supports EG activities including leading development, implementation and adoption of strategic and innovation planning, sourcing strategies, service provider governance, service provider management and systems, business processes and compliance activities for all EG service providers including those used for clinical operations, biostatistics, data sciences, and data management.
MAJOR RESPONSIBILITIES:
Project Management:
Deliver consistently on high quality project management to enable Evidence Generation and/or functional organizational success. This includes:
Leading the development and implementation of global and EG initiatives and acting as a trusted thought partner to EG personnel or Respective Functional teams both within and outside of USMA.
Track and monitor progress, resources and impact of EG functional activities and local and global initiatives.
Execute on the planning and facilitation of functional meetings, including: agenda development, meeting facilitation with focus on team inclusion, and capturing key documentation with follow-up on action items as needed.
Identify risks and lead the team in developing risk mitigation strategies.
Lead stakeholders through the translation of customer needs into project and program level specifications
Strategic & Innovation Planning
Represent business strategy and guide relevant activities in support of therapeutic area objectives with a focus on innovative solutions
Partner with therapeutic area leadership through problem identification, tracking and solving.
Enable operational excellence based on the continuous review of current processes and the identification of opportunity areas that create efficiencies and improve outcomes.
Drive local and global development of collaborative research studies with digital health thought leaders that invite innovative clinical trial solutions with the medical network.
Provide scientific and clinical input during the development and execution of USMA studies in order to support above-molecule clinical trial innovation and execution.
Evaluate and understand the health technology systems landscape.
Understand the changing healthcare environment and enable broader clinical trial participation in order to bolster real-world effectiveness of GNE portfolio.
Demonstrate mastery of all components of managing highly complex relationships with the service providers for the benefit of the Evidence Generation portfolio.
Promotes and embeds a culture of innovation, smart risk taking, customer centricity and customer relationship management.
Work at a global level to streamline processes and share information across business units for lessons learned, best practices and improvements to drive better outcomes.
Sourcing Strategy
Create and lead the implementation of the EG (Clinical Operations, Biometrics and Data Sciences) sourcing strategy
Collaborate with local and global key stakeholders to identify and raise opportunities for improvement initiatives, innovation and change and existing best practices for inclusion as appropriate into the Sourcing Strategic Plan
Liaise with internal and external collaborators so that USMA operational service provider strategies align with other enterprise units as needed
Identify functional best practices and process improvements and coordinate their development and implementation for suppliers.
Partner with procurement and local and global cross functional stakeholders to define and streamline the service provider landscape
Evaluate potential service providers selected for inclusion in EG as needed
Identify and evaluate technology service providers to help accelerate and innovate clinical trial execution.
Service Provider Oversight
Ensure implementation of a continuous improvement mindset to ensure that sourcing projects and portfolio commitments are delivered according to time, cost and quality requirements
Partner with local and global stakeholders to understand their expectations and requirements of the service providers, monitor trends and issues and ensure concerns are addressed in a timely way
Leads process of contingency planning for outsourced service to minimize risk to the business and ensure activities are delivered.
Proactively manage relationship and escalation pathway for new and existing EG service provider relationships
Initiate, recommend, and implement quality, process and efficiency improvement initiatives for EG related to sourcing strategies and service provider management based on trends, study/process debriefs, audit findings, CAPAs and internal/external benchmarking data
Service Provider Management
Serve as the central point of contact for internal and external management with partners/external service providers
Lead the cross functional joint meetings between GNE and our service providers, responsible for developing the agenda, facilitating the meeting, writing minutes and tracking action items to completion
Participate in local and global forums representing USMA specific needs
Foster and develop relationships across the organization to ensure consistent approaches to service provider management
Facilitate and execute governance activities
Proactively manage the ongoing relationships with key partners to drive external provider performance excellence, develop best practice and inform future provider decisions
Identify and implement opportunities to continuously improve performance of suppliers
Lead communication with USMA centric service providers
Systems, Business Processes and Compliance
Provide guidance to EG and/or functional organization to ensure systems and local and global business processes are implemented
Proactively identify risks, including process gaps, escalating the issues to appropriate stakeholders.
Work with the team and appropriate compliance/process SMEs, solve complex issues through appropriate risk mitigation
Create, contribute or support the development of relevant policies, SOPs and associated documents for new and existing process documentation
Partner with gMAC on processes and training interventions to ensure that USMA EG is fully compliant to GCP principles and internal local and global Roche/Genentech processes and procedures
Required Qualifications and Experience:
- University degree or equivalent in a scientific discipline.
- Minimum of 10 years’ experience in pharmaceutical/biotech, preferably in clinical development
- Strong knowledge of GCP and ICH guidelines and local regulatory requirements
- Proficiency in English, both written and oral
- Business travel, by air or car, may be required for internal and external business meetings
Preferred Qualifications and Experience:
- Advanced degree or equivalent in a scientific discipline
- Medical Affairs experience (minimum 2 years)
- Put Patients First: I always act as if patients I know are in the room and do what's best for them.
- Follow the science: I seek answers through experiments, data and debate, and act on facts.
- Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.
- Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.
- Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.
- Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.
- Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.
- Think long term: I choose actions today that benefit future generations.
The expected salary range for this position based on the primary location of California is $164K to $304K. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
This position is preferably located in South San Francisco, CA, However, we welcome candidates from all US territories as working remotely is a possibility.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.