The Head of Early Clinical Development Informatics is accountable to provide strategic leadership and effective oversight of multiple functional areas including: Clinical Development Informatics, System Development and Operations, Information Management Office, Data Science and Predictive Analytics for global Genentech Research and Early Development (gRED) Early Clinical Development (ECD). An emphasis on developing cross functional regional systems and information strategy within the global environment for all therapeutic areas that include effective external/internal collaborations and alliances with Senior leaders and key stakeholders across the gRED and the Global Roche organization. He/she will serve as the primary interface for specified functions with Senior Director and VP and SVP representatives from gRED Research, gRED Development Sciences, Product Development (PD) Biometrics, ECD Clinical Science, PD operations, gRED and PD IT.
This position oversees staff of 40+ individuals to include a director level leadership team. He/she develops long term strategy for the specified functions in partnership with ECD Clinical Science and Clinical Operations to enable successful delivery of programs within approximately a 5-year horizon. The Head is responsible for creating the vision, building, and developing the Information Management and Data Science strategy for Early Clinical Development.
Primary Responsibilities and Accountabilities:
Strategic direction and oversight to the following business areas:
Clinical Development Informatics (CDI)/Data Science
Develop a successful data science team in order to enhance Early Clinical Development with the use of predictive analytics
Identify machine learning and/or statistical concepts to be applied to various scientific and business questions
Partner with data custodians across the enterprise to integrate and find patterns in massive data sets using data science tools and methodologies
Lead the investigation, sourcing, and application of both internal and external data sources
Use life science data assets to support the protocol development process by quantifying the size of and geographically identifying specific patient populations
Collaborate with Molecule project teams (including the Medical Director, Development Scientist, Research Scientist, Drug Safety Scientist, Project Team Leads (PTLs.) and Biostatistian to conduct analysis to answer critical scientific questions to support molecule development (decision enablement, protocol development) across ECD including exploratory analysis.
Services delivered and developed as a core function and on a project-by-project basis to include some or all of the following: data curation, data aggregation, data standardization, data analysis (using advanced statistics) and data visualization using a variety of tools (Rshiny, etc.). Depending on the project and resourcing model, some or all of these services may be performed entirely within the CDI group or may be outsourced and managed by CDI or performed by another department.
CDI will project manage data exploration and analysis, identify data sets, evaluate requirements for acquisition and de identify data as required. CDI will support the teams' development of proposals and interpretations for presentation to governing bodies.
System Development and Operations
The Systems operations group collaborates closely with the following functions as appropriate to develop and deliver functioning systems for clinical operations: PDIT, gRED IT, External Consultants, External Vendors, Roche and Genentech Operations and Clinical Data Management.
These systems include but are not limited to the following: IXRS, EDC, CTMS, ePRO, EMMA, FeLIX, DASH, gCOR,
The System operations team is comprised of technical experts in the design and management of systems required for clinical trials. They do not have traditional clinical operations backgrounds. They do not program or directly develop new tools, but they serve as the connection between technical vendors (internal and external) and the business. They are accountable to translate business needs to system function. This is done at a tactical and strategic level.
The Systems Operations team determines system and user requirements based on departmental strategy, business objectives and priorities, relevant SOPs and regulations, protocol specifications, process gaps, and other relevant factors.
The Systems Operations group determines the appropriate vendor relationships, determines data integrations (flow between systems), system specifications, etc. The team will take the appropriate steps to ensure system availability and functioning, which may include programming, overseeing a vendor and or an internal function. The Clinical Studies Systems Implementation Leader (CSSIL) team will lead and complete user acceptance testing. The approach taken is tailored to the tool and situation. For tools managed by Roche PD (CTMS, eDC). In these cases the team will do a thorough system evaluation and make the necessary adjustments in process, system design (through requests and collaboration with the owning function), etc.
The CSSIL group selects and on boards new vendors such as Bracket (IXRS). They serve as the interface between the business, IT, the vendor and Sr. Management. They are accountable for delivery of the systems per business specifications.
For a new study, the CSSIL works with the Study lead to identify, configure, launch and manage relevant systems.
Information Management Office
Accountable for access to and integrity of data used in gRED ECD systems. This includes:
Data architecture and strategic planning: The Information Management Office (IMO) is accountable for the development of a long-term data strategy for gRED ECD. This includes architecture and roadmap for gCOR, the data repository / warehouse for gRED ECD. The requirements, strategy and architecture were developed and lead by the IMO function. Vendors (cognizant) were hired (by IT with budget requested and defended by CRI to do much of the actual build as is the case for most systems and warehouses across Roche.
Data acquisition: Identify new and evaluate new data sources whether (internal or external) according to business need. New sources must be evaluated for completeness and quality, characterized and then associated with existing data
Data verification: Developing and programming automated data quality processes and programs. Ensure adherence to appropriate data handling SOPs, regulations, guidance documents, etc.
Data Curation: Ensure users understand the meaning and content of data sets, establish data history, provide access, update and maintain live data sets, etc.
Data Standardization: Lead data standardization discussions across gRED ECD.
Data Science/Predictive Analytics
Provide vision and oversee the development and implementation of analytic methods and tools to provide planning support (identify and or develop data sources) at the following levels:
Protocol: Help clinical science and operations teams evaluate and understand disease epidemiology in all relevant countries and how it will affect the protocol. Provide analysis of all relevant clinical trials in a 3 year time horizon (primarily external) to determine enrollment rates, screen fail rates and the impact of competition and changing standards of medical care in relevant countries and regions. Support teams to develop remediation strategies for struggling studies. Support approximately 35 teams per year across 15+ Therapeutic Areas and indications.
Program: Includes all of the above information but for multiple protocols within a molecule including an integrated model (across protocols) to support the CDP. Information provided supports presentation to governance bodies (gPRC, DRC, etc.). Approximately 10 to 20 Program analyses are conducted per year.
Disease landscape: Includes any or all of the above information but now includes multiple molecules for a disease area.
Portfolio level: Identify and visualize trends in the portfolio, develop performance metric and reporting. Examples include line-of-sight presentations, Partner Book of Business, etc. Provide advanced statistical analysis of key performance variables to inform departmental strategy.
Use Cases: Develop and or obtain the necessary analytic tools and visualizations to support data driven decision-making.
Resource Management & Investigator Payments
Resource Management: Provide decision support for functions and sub functions managing regular and contract HC. Support finance in forecasting and reporting on actuals, trends and variance to budget.
Develop methodology and required tools (gRAM)
Accountable for a functional budget of approximately $15 million.
Responsible for functional strategic planning horizon of 5-10 years in all areas as described above.
Responsible for developing the Systems, Informatics, and Analytics vision and strategy for the above functions
Who You Are
A proven leader with 13+ years experience managing system and analytical aspects of clinical information from strategic development to effective execution
8+ years direct personnel management experience
Data Science, machine learning, and artificial intelligence experience preferred
Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
Previous experience in managing multiple groups or business units
Bachelors Degree or equivalent required (scientific or healthcare discipline preferred). Advanced degree strongly preferred. (Candidates with comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.)
Knowledge of international regulatory and ICH GCP guidelines
Experience, Skills, Knowledge:
Proven track record of successful direction and expertise in managing complex Early Development clinical systems and analytics.
Comprehensive Clinical analytic experience including relevant experience working with clinical science and research.
Exceptional reputation for significant leadership and management
Strong communication, collaboration, presentation, and interpersonal skills and the ability to form strong cohesive partnerships.
Excellent judgment and analytical skills with a demonstrated ability to diagnose issues, manage conflict, and provide alternative solutions.
Other (e.g. Travel): Willingness to travel domestically and internationally, and work across cultures
Who We Are
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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