Director, Medical Informatics & Data Management Lead

ROLE SUMMARY

The mission of Digital Medicine and Translational Imaging (DMTI) is to solve key business problems using dynamical measures, advanced-STEM platforms and a collaborative network of external and internal stakeholders to support development, validation and deployment of novel digital endpoints in clinical trials. DMTI and the Pfizer Innovation Research Lab (PfIRe Lab) utilize industry-leading mobile/sensor technologies to enable continuous remote monitoring of patients' symptoms and behaviors for disease diagnosis, health state assessment, and eventually as novel digital clinical endpoints with regulatory significance.

The Director, Medical Informatics & Data Management Lead will be instrumental in the development and execution of the clinical data management strategy for DMTI and PfIRe Lab studies using wearable devices, sensors, and remote monitoring. They will supervise a team overseeing highly complex projects and accountable to collect, process, and review clinical trial data received in-house and remotely. They will ensure that the data is complete, accurate, high quality, and regulatory compliant in support of publications and regulatory submissions according to external regulatory requirements, and internal standard operating procedures (SOPs) and deadlines.

The successful candidate will be a member of a highly motivated and engaged team of data scientists, clinicians, technicians, and project managers who are responsible for the day-to-day execution of DMTI and PfIRe Lab clinical studies developing novel digital endpoints to support the Pfizer portfolio. S/he will work in close partnership with colleagues from Worldwide Research, Development and Medical (WRDM) Research Units and asset teams from Global Product Development (GPD), on the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data. They will need to communicate effectively with the DMTI Leadership Team (DMTI LT), lead colleagues within a matrix organization, and leverage information from a variety of sources in order to effectively understand organizational and study level strategy to help drive study decisions. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers and Pfizer.

ROLE RESPONSIBILITIES

• Oversee the overall architecture of data pipelines and workflows for DMTI; accountable for collection, organization, curation, and storage of sensor data from PfIRe Lab, asset teams, and external collaboration studies.
  
• Play leadership role in developing data management plans including data preparation, data review (QC), and data validation activities according to Pfizer SOPs to ensure the data is traceable, original, of high quality, and ready for statistical analysis.
  
• Lead interactions with Data Management and Monitoring group for creation of data standards, Data File Specifications, and Data Transfer Specifications for novel digital endpoints based on sensor data.
  
• Author SOPs for PfIRe Lab, develop study CRFs according to CDISC standards, and drive establishment of good clinical practice (GCP), striving to safeguard patient data through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up, in a manner consistent with 21 CFR Part 11
  
• Ensure that DMTI processes meet business requirements and industry best practices, while being compliant with Pfizer policies and standards.
  
• Serve as informatics expert for vendor management, EDC and eSource development and configuration for PfIRe Lab clinical studies.
  
• Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications. Leverage and oversee external collaborations to further the organizational goals in digital medicine.
  
• Serve as informatics lead handling stakeholder management for change control processes and implementation of standardization of database structures and ontologies for current and future projects.
  
• Support and participate in the development and implementation of CONFORM data ingestion platform, ensuring adherence to informatics best practices and collaborating with internal stakeholders, vendors, GPD, Pfizer Digital, SMEs, and vendor project management and technical team
  
• Built world class data management team, able to recruit, engage and develop a team of high performing data management professionals in a fast pace, cross-functional setting
  
• Deploy data solutions at scale in a cloud environment
  

BASIC QUALIFICATIONS

• MD, PhD, or Advanced degree in Medical Informatics with 6+ years of industry experience. Must have experience in clinical research informatics, as well as early phases of exploratory and clinical trial design and operation.
  
• Working knowledge of medical terminologies: MedDRA and WHO-DD
  
• Working knowledge of SDTM and CDASH principles
  
• 2+ years' experience with AWS or other cloud-based development, Python, Unix/Linux environments
  
• Strong interpersonal and leadership skills
  
• Demonstrated the ability to build consensus and drive change across the organization
  
• Must have deep understanding of processes and policies around data management, regulatory requirements and site coordination for good clinical and informatics practices.
  
• Experience with leading the electronic data capture (EDC) and eSource development; Proficiency with at least one EDC system, e.g., Oracle InForm or REDCap Cloud
  
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  

PREFERRED QUALIFICATIONS

• Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management
  

OTHER JOB DETAILS

• Eligible for Employee Referral Bonus
  
• Eligible for Relocation Package
  

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical