Executive Director, Clinical Data Management

Location
San Francisco, CA, United States
Posted
Feb 09, 2021
Ref
5301-525-R
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for an Executive Director, Clinical Data Management to join their team.

Responsible for all aspects of Clinical Data Management (CDM) operations at Nektar. Sets strategic visions for the function including CDM strategies and operations, data management infrastructure, technology advancement, and talent development. Provides strong leadership and inspiration to the CDM team. Champions new process development and implementation when needed. Promotes standardization, automation, and innovation in CDM. Directs and oversees CDM activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Provides oversight and guidelines to Contract Research Organizations (CROs) for any outsourced CDM activities to ensure data quality/integrity and regulatory compliance. Ensures productive collaborations between CDM and other functions, including Biostatistics, Programming, Clinical Operations, Clinical Development, Regulatory Affairs, QA, and IT, to maximize development efficiency. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
  • Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Ensures budgets, schedules and performance requirements are met.
  • Sets visions for CDM strategies, operations, infrastructure, and technology advancements. Establish sound processes to ensure data quality/integrity and regulatory compliance.
  • Provides strong leadership and inspiration to the CDM team. Recruits, develops, and retains high talents.
  • Promotes standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency.
  • Forecasts and manages budget, timelines, and resource needs with sound judgment and efficiency.
  • Leads the development and implementation of policies, standards and process improvement initiatives related to CDM. Participates in corporate development of relevant methods, techniques, and standards for projects, programs and people.
  • Works on critical problems across functional areas of the business. Identifies potential issues for the functional area as industry advances and works out solutions with stakeholders.
  • Interacts internally and externally with executive level management requiring negotiation of difficult matters to influence decision-making.
  • Directs CDM activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release.
  • Ensures that Data Management Plans (DMPs) are consistent and regulatory compliant across studies and programs (DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan).
  • Provides oversight and guidelines to CROs to ensure timely delivery and regulatory compliance of outsourced activities. May oversee CROs data management function inspections and audits.
  • Manages a large group and provides performance evaluations to direct reports.Performs other activities as assigned.
A minimum of BS degree in clinical, biological, mathematical, statistical, or computer science is required. An MS degree in quantitative science or computer science is preferred. A minimum of 15 years of pharmaceutical development experience with at least 8 years of line management experiences is required. Extensive experiences with regulatory inspections and with NDA/BLA submissions. Advanced knowledge of CDM processes, systems, and technology advancements in the field. Solid understanding of clinical drug development processes and advanced clinical trial designs. Profound understanding of ICH, GCP and other regulatory guidance related to data management. Outstanding problem solving abilities and influencing skills. Excellent skills in evaluating technical solutions for CDM. Excellent interpersonal, communication and leadership skills. Demonstrated ability and sound judgment on budget forecast and management. Proving management skills to lead a large group and to inspire staff.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.