Director, Clinical Data Management

Job Locations US-CA-South San Francisco
ID
2022-1091
Category
Clinical Operations
Position Type
Regular Full-Time

About Us

Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, early-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer.

 

Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019. Clinical trials for 101 are in process; 019 will begin in H2 2021. Nkarta recently announced a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.

 

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation.  We have a 2,700-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.

 

Overview

Reporting to the Executive Director of Biometrics the Director of Clinical Data Management will be responsible for leading and managing all Clinical Data Management (CDM) activities to meet corporate timelines and objectives. The Director of CDM will be responsible for building and leading the CDM function and for setting strategies for the CDM function.

Responsibilities

  • Develop and implement the vision and strategic direction for CDM across all clinical trials
  • Oversee vendors contracted to support CDM activities for multiple clinical trials
  • Participate in the planning and protocol review of all clinical studies to ensure optimal CRF and EDC design
  • Partner with Clinical and Biometrics to develop comprehensive DMPs covering all aspects of data collection, processing, reconciliation, review, and storage
  • Works closely with other Biometric functions to monitor all incoming data during study
  • Plan and facilitate data review meetings in conjunction with other clinical development functions
  • Lead or direct discrepancy management
  • Plan and facilitate database lock
  • Develop standardize work practices and procedures in alignment with CDISC standards, GCP, GCDMP and ICH guidelines
  • Perform resource planning and budget forecast for CDM related activities
  • Manage timelines for all CDM activities to support corporate objectives
  • Ensure complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans
  • Ensure all CDM documentation are complete, accurate and in an inspection-ready state
  • Act as team SME for key systems and processes, and process enhancement efforts
  • Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, technology advances, and quality assurance
  • Recruit, develop, and motivate CDM staff as required

Qualifications

  • BS/BA and/or MS degree or equivalent combination of education/experience in science or health-related field with 8+ years of direct data management experience (oncology experience highly desirable)
  • Strong knowledge of CDM processes, EDC systems (RAVE preferably), database programming, quality management and technology advancements in the field of data management
  • Understanding of the MedDRA and WHODRUG coding processes
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
  • Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
  • Outstanding problem-solving abilities and influencing/negotiation skills
  • Excellent interpersonal, communication, and leadership skills
  • Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
  • Willing to travel if required

Working at Nkarta Inc.

The 130+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas in which we’re working, here are real anonymous comments of why people think Nkarta is a great place to work.

 

  • People are always open to ideas. This company provides a safe place for its employees (covid testing, etc.)”
  • Exceptionally talented, committed, *kind* & supportive team”
  • The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”
  • Not to sound corny, but the emphasis on people as a valuable resource is something I  recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”
  • It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”
  • We have a very diverse team with executives that are friendly and accessible.”
  • Smart and dedicated colleagues. Mission to make a difference in patients lives. Empower us with tools needed to succeed.  Open and transparent culture. Transparent leadership. Handling of covid and running the company was done very well.”

 

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website at https://www.nkartatx.com

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed