Director, Clinical Data Management

Summary

Directs planning and execution of clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Manages Contract Research Organizations (CROs) and service providers throughout the data management process life cycle, coordinating with Biostatistics, Clinical, and Regulatory teams to ensure accurate, efficient, and complete clinical trial data collection. Supports the advancement of high-value therapeutics addressing unmet medical needs.

Essential Duties & Responsibilities

Directs planning and execution of clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Manages Contract Research Organizations (CROs) and service providers throughout the data management process life cycle, coordinating with Biostatistics, Clinical, and Regulatory teams to ensure accurate, efficient, and complete clinical trial data collection. Supports the advancement of high-value therapeutics addressing unmet medical needs.

Qualifications and required Experience

Demonstrated problem solving abilities and strong organizational skills. Strong written and verbal communication skills are required. Experience and understanding of ICH and GCP is required. Demonstrates initiative and strong interpersonal collaboration. Excellent project management skills required. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. Strong computer skills with proficiency in Microsoft Project, Word and PowerPoint.

Education and Minimum Required Experience

A Bachelors degree in clinical, biological, mathematical sciences or related field, or nursing qualification is required. An advanced degree is preferred. Equivalent experience may also be considered.

13 years of pharmaceutical development experience with at least 6 years managing CROs is required. Extensive experience in the design of clinical studies is required. 10 years of previous management experience is preferred.

Additional Information

Nektar currently anticipates the base salary for the Director, Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidates location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Companys discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical/Dental/Vision)

Disability Insurance

Holiday Pay

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.nektar.com/careers.