Director, Clinical Trial Optimization

About Us

Nkarta is a publicly traded (Nasdaq symbol NKTX), biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out into the community setting, dramatically expanding access for patients.

Founded in 2015 at the birthplace of biotechnology, Nkarta is a fast-growing, fast-moving, clinical-stage company that has built an extensive cell therapy manufacturing operation in anticipation of product commercialization. Our developmental pipeline of engineered NK cell therapies includes clinical programs in B-cell malignancies and autoimmune diseases.

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation. We recently built out a 23,000-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California.

Nkarta is a people-driven company looking for passionate, collaborative, driven team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.

Overview

The Director, Clinical Trial Optimization leads strategic feasibility and scenario planning to inform clinical trial design that aligns the science with data driven, efficient delivery plan. This role is responsible for the review and approval of Clinical Operations strategies, SOPs and written standards, as well as a key contributor to issue review and recommendation/resolution processes. The role serves as a champion and leader for staff change management and engagement strategy, continuous improvement projects that promote individual development, team development, development of institutional knowledge, and best practices for leveraging the entire Clinical Operations network in an optimal manner.

Responsibilities

• Oversee alliance management, cultivating robust relationships with CROs, vendors, and other external partners, managing contracts and outsourcing effectively.

• Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed across all assigned clinical stage programs.

• Identifies areas of improvement and implements action plans to meet these. Seeks ways to improve operations and oversees the preparation of productivity reports.

• Identifies optimization aspects for development of electronic documentation solutions that support clinical workflow and practice and align with the current best practice standards utilizing innovative technology to enhance the clinical processes and user experience.

• Establishes and continuously assesses the effectiveness of the internal controls within Clinical Operations with Nkarta SOPs, policies and procedures. Ensures staff are trained Nkarta SOPs, policy and procedures.

• Resource management across Clinic Operations, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid Clinical Operations

• Drive innovative approaches to study delivery through external facing advances in technology and science.

• Patient Recruitment Strategy roles; as well as Investigator Budgets & Payments Team.

• Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed across all assigned clinical stage programs.

• Establish and lead a Feasibility Center of Excellence, partnering with preferred CROs to deliver data-driven, optimized clinical trial scenarios, and developing innovative feasibility tools and processes.

Qualifications

• Experienced in industry with expertise in the areas of clinical operations development and strategic planning.

• Experienced with early to late-stage clinical trials, and with the IND to BLA process (able to manage clinical operations for a product from pre-clinical through all clinical phases and product launch)

• Demonstrated leadership in a clinical operations role

• Ability to multitask and lead a team in a fast-paced, small company setting.

• Previous experience as a people manager and/or mentor

• Willingness and ability to travel domestically and international as required.

• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.

• Excellent planning and organizational skills and ability to handle multiple tasks and deadlines.

• Ability to think critically, and demonstrated troubleshooting and problem solving skills.

• Excellent written and oral communication skills, including presentation skills.

Education/Background

• BS/BA degree in related discipline and a minimum of 12 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 10 years of related experience; or,
• PhD in related discipline and a minimum of 8 years of related experience; or,
• Equivalent combination of education and experience.

Working at Nkarta Inc.

The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Car and airplane travel might be required of this role for conferences and meetings. This role is local to the office in South San Francisco; however, the team works a hybrid schedule with work from home days.

A reasonable estimate of the current salary range for this position is $237,000 - $267,000. There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as the value of other elements of an employee's total compensation package. Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans. Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.

The 150+ 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 on which we are working, here are real, anonymous comments about or regarding 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.