Senior/Executive Director Head of Biometrics

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Job description

About Us

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.

The Head of Biometrics leads biostatistical-related activities related to the clinical trial design, analysis and interpretation of clinical trial data for each program. In addition, this individual is accountable for overseeing/building a world class team that includes data management and statistical programming and identifying technology needs or other gaps. The Head of Biometrics partners with other functional leaders from Clinical Development, Clinical Operations, Drug Safety, Regulatory Affairs, Research, and others in support of the project teams and of the organization. High-level negotiation and oversight of CROs and provides oversight of CRO/sponsor partnership.

Responsibilities

• Lead the Biostatistical and Clinical Data Management function driving best practices and improving overall quality and processes.
• Develop and as needed expand the Biostatistical and Clinical Data Management team.
• Provide program development teams with innovative strategic input and technical expertise on statistical methodologies for clinical studies.
• Ensure that the organization credibly communicate clinical trial data internally and to Health Authorities, the academic community, and healthcare providers, as appropriate.
• Ensure that the interpretation of data obtained from trials, from trials conducted by collaboration partners, CROs and competitive data is accurate, scientifically sound and credible.
• Stay current with FDA and EMA regulations and guidance as well as novel trial designs used for marketing authorization and communicate any updates to key stakeholders.
• Provide strategic guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, DSUR/PSUR).
• Participate in regular meetings of each program, Clinical-Regulatory Leadership committees and Executive Leadership Meetings (as needed).
• Develop strong and collaborative work relationships with key business stakeholders (e.g. Project Team leaders, functional heads within Clinical Development, Research and others).
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
• Mentor and coach direct reports to maximize their potential.

Qualifications

• Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required; experience in cell/gene therapy preferred
• In depth knowledge of ICH, FDA/CDE, and GCP regulations and guidelines; strong well-rounded technical skill
• Strong business acumen and critical thinking
• Excellent oral communication skills and leadership abilities
• Experience interacting with health authorities
• Prior management experience required

Education / Background

PhD in statistics or biostatistics with minimum of 12 years of experience in the pharmaceutical or biotechnology industry

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 $280,000 - $349,000. 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 .

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