Sr. Manager/Associate Director, Clinical Trial

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Job description

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 Clinical Trial Sr. Manager/Associate Director works closely with the director of clinical operations and the rest of clinical and leadership team to ensure successful execution of clinical trials. The role manages operational activities of assigned clinical programs, oversees internal and external staff for the timely and quality implementation and execution of clinical trials. Partnership with key internal and external stakeholders to ensure continuous harmonized operations of clinical operations activities is critical. Works closely with investigative site personnel, CROs, and other study vendors. Ensures conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

Responsibilities

• Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program
• Coordinates activities within various phases of clinical studies (i.e. study planning, site qualification and selection, monitoring, data review and cleaning, closeout, etc.).
• Maintain study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines.
• Lead risk management/mitigation plans to ensure delivery to quality, budget and time and raise issues to partners.
• Responsible for oversight of CROs and other clinically outsourced third-party vendors for outsourced studies and programs
• Assists in selection, management and oversight of other external vendors (e.g. CROs, clinical labs, etc.).
• Participates in development essential study documents (study protocol, ICF, Case Report Forms, Clinical Study Reports, etc.), as appropriate.
• Develops, reviews/approves clinical study plans, manuals, presentations, other study documents (country/site specific ICF's, site facing documents and tracking tools), assists with user acceptance testing, sample and product tracking, and other activities as needed.
• Helps identify and recruit clinical investigators. Builds and maintains great working relationships with KOLs and PIs. Trains investigators and investigative site staff.
• Participates with in-house data review.
• Assists with external vendor partner management. Includes review of invoices for accuracy compared to vendor contract. Coordinates and participates in the development of technical specifications for vendors (e.g. scope of work, review and approval of specifications, procedural manuals, etc.).
• Handles other duties and responsibilities to support successful execution of assigned clinical programs.
• Assists in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements.
• Oversight of clinical study sites up to 20% of travel; review reports for PSSVs, SIVs, IMVs, and COVs as required
• Contributes to wider organizational goals and/or activities as assigned.

Qualifications

• Experience in autologous or allogeneic cell therapies in autoimmune indications.
• Minimum 4 years experience in the management and execution of a clinical trial at a sponsor or CRO.
• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), and medical terminology for clinical trials.
• Excellent planning and organizational skills.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Excellent written and oral communication skills, including presentation skills.
• Ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
• Able and willing to travel domestically and internationally (approximately 20%).
• Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail.
• Flexible and solution focused.
• Prefer candidate that is located in the Greater San Francisco area and able to work a hybrid schedule in the office in South San Francisco a couple of days per week, but open to fully remote for the right candidate.
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Education

BS/BA degree in related discipline and a minimum of 8 years of related experience; or,

MS/MA degree in related discipline and a minimum of 5 years of related experience; or,

PhD in related discipline and a minimum of 4 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 $155,000 - $221,000. 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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