The Director, Informatics lead is responsible for leading the development and execution of the informatics strategy for Digital Medicine and the Pfizer Innovation Research (PfIRe) Lab clinical studies. The mission of Digital Medicine and the PfIRe Lab is to solve key business problems using dynamical measures, advanced-STEM platforms and a collaborative network of external stakeholders, regulators and internal enterprise-wide colleagues to support a digital therapeutic pipeline. Digital Medicine and the PfIRe Lab is an industry-leading mobile/digital technology initiative striving to utilize digital continuous remote monitoring of patients’ symptoms as novel endpoints for disease diagnosis and health state assessment. The goal is to construct systems in which, first, digital continuous/dynamic measurements in patients are used for diagnosis and health state monitoring, and eventually clinical trial endpoints with regulatory significance. For Digital Medicine projects, a structured approach will be used to solve key business problems and identify the opportunities to generate value through dynamic measurement and transforming clinical development and patient care through the validation and application of new technology platforms. The Informatics Lead will be member of a motivated and engaged team of informaticians and developers who are responsible for the day-to-day clinical execution of Digital Medicine and PfIRe Lab Clinical Studies and Digital Innovation projects. This team will work closely with all research team members to translate and industrialize the technology into clinical trials. Critically this individual will also contribute to the development and implementation of the Regulatory, Early Clinical Data Highway, and data standards strategy for the PfIRe Lab and Digital Medicine programs.
Roles and Responsibilities
- Serve as an Informatics expert and a key contributor to design, management and operationalization of the clinical programs of the PfIRe Lab and Digital Medicine Projects. These include human biology studies, methodology studies in healthy volunteers, clinical research collaborations at a small number of academic and multispecialty medical centers, and to apply best practices of informatics for the validation studies for the PfIRe Lab clinical studies during prototype development, study design, and influence the scaling and industrialization of the validated prototype into a Pfizer phase three clinical trial.
- Responsible for safeguarding patient safety in studies through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up.
- Responsible for clinical study execution in a fashion consistent with GCP requirements and applicable Pfizer internal compliance processes.
- Partners with colleagues in ECD, PfIRe Lab clinical studies, Digital Medicine research teams, Clinical Pharmacology, Biostatistics, Development Operations (including ECDH and mClinical), Regulatory, Data Standards and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered studies.
- Contributes to development of a long range strategy in the PfIRe Lab clinical studies and Digital Medicine program, including medical, translational, regulatory and operational aspects.
- Serve as informatics expert for vendor management, EDC and eSource development and configuration for PfIRe Lab clinical studies.
- Serve as informatics lead for stakeholder management for change control processes and implementation of standardization of database structures and ontologies for current and future projects.
- Collaborates with the external partners, collaboration colleagues and academic colleagues to develop and establish appropriate criteria for the existing and future PfIRe Lab studies validation and experimental biology studies.
- Tracks emerging study data and works closely with bioengineering and quantitative colleagues to ensure effectiveness of tools and capacity of validation populations to prove the valid performance of techniques developed for endpoint measures on an ongoing basis to ensure data quality.
- Support and participate in the development and implementation of IPM ensuring adherence to informatics best practices. Drive the development and testing of IPM tool by collaborating with internal stakeholders, vendors, IPM team, SMEs, and vendor project management and technical team
- Establishes relationships with key teams and external clinical experts and institutions to ensure implementation of best informatics practices and guidelines into clinical development plans.
- Represent the scientific teams at medical informatics meetings and presentations, interactions with disease foundations, as well as other public relations opportunities.
- Flexible and entrepreneurial in supporting the uncertainties of development in Digital Medicine and PfiRe Lab portfolio.
- MD, PhD, or Advanced degree in Medical Informatics with 6+ years of industry experience. Must have experience in clinical research informatics and early phases of exploratory and clinical trial design and operation.
- Deep medical informatics, scientific and clinical knowledge; comprehensive understanding of the landscape of medical data structures, semantic medical ontologies, data processing and handling tools, and leading edge medical technology.
- Experience with ontological development and interoperability standards implementation in clinical research environment.
- Must have deeper understanding of processes and policies around data management, regulatory requirements and site coordination for good clinical and informatics practices.
- Experience with leading the EDC and eSource development.
- Deep understanding of the biopharmaceutical environment and the drug development process, and a proven track record of success in executing development programs to completion in early development.
- Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change across the organization.
- Able to be entrepreneurial and focus relentlessly on delivering success at all costs on tight and immutable timelines.