Associate Director/Director, Medical Writing - Nkarta, Inc.

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.  

This role is a key critical hire for Nkarta. The role works hands-on, directly with teams and management to produce high quality clinical program documents to support regulatory submissions and scientific communications while simultaneously building up the team. For the right candidate, there is an opportunity to expand medical writing function into a central resource for the company to support both research and CMC teams in pertinent non-clinical and CMC sections of the regulatory submissions.  

• Reviews, analyzes and actively summarizes data to be used in clinical study reports or other high quality scientific communications and regulatory documents.
• Project manages the timely completion of high-quality documents to support submissions to health authorities.
• Builds a robust medical writing team of internal employees and external contract medical writers for a fast-growing cell therapy company with multiple products in clinical trials
• Oversees contract medical writers to ensure high quality documents are produced.
• Builds robust processes for rapid and high-quality clinical development documents including protocols, amendments, Investigator brochures, etc.
• Develops, implements, and uses templates based on international guidelines and regulations. 
• Obtains and reviews pertinent literature, evaluates applicability, and incorporates that information into clinical documents.
• Opportunity for the right candidate to build a central function that can support preparation and review of CMC reports and Module 3 sections of regulatory submissions; and/or the preparation and review of pre-clinical study reports and pertinent sections of regulatory submissions used to justify clinical study design and translational endpoints.
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

• Excellent understanding of the drug development process.
• Direct regulatory writing experience for INDs, BLAs, Protocols, CSRs, Briefing Documents, DSURs, IBs etc. 
• Good understanding of experimental methods, research design, and statistical analysis.
• Ability to analyze medical data and interpret its significance within a biopharmaceutical setting.
• Advanced scientific, technical reading, writing and editing skills.
• Excellent oral communication skills and leadership abilities.
• Proficient computer and word processing skills including electronic publishing skills

Education/Background

• Advanced degree and at least 5 years biopharma medical writing experience. 
• Experience with autoimmune and/or oncology pharmaceuticals; cell therapy experience is a plus.

The common requirements of an office environment (computers, computer screens, workstations, etc.) apply, and there is no anticipated work in a laboratory environment. Car and/or airplane travel might be required of this role for conferences and meetings. This role is remote, and a West Coast location/Pacific Time Zone is preferred. There is required travel to the office in South San Francisco, approximately every one to two months. Advanced notice and travel support is provided.

A reasonable estimate of the current salary range for this position is $176,000 - $230,000.  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.