Senior Director/Director, Drug Safety & Pharmacovigilance at Nkarta Therapeutics
South San Francisco, CA, US
Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting.
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 NKX101 NKX019 are in process. 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 manufacturing facility on-site at our primary corporate location in South San Francisco, California. In-house manufacturing of NKX019 commenced in 2021, and NKX101 in-house manufacturing is planned to begin in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.
Nkarta is hiring an experienced drug safety leader who will provide oversight and management of activities pertaining to Nkarta’s drug safety and pharmacovigilance activities for products currently in clinical development.
The successful candidate will work closely with the Chief Medical Officer, the clinical development lead, regulatory affairs and other key cross functional stake holders to ensure proactive safety surveillance, PV and risk management activities.
In this role you will leverage broad knowledge and expertise to work collaboratively with colleagues at Nkarta and with the CROs in ensuring clinical trial participant safety is maintained and risks minimized while supporting the rapid advancement of Nkarta’s novel products. Nkarta fosters a diverse, supportive and collaborative culture with a can-do attitude and the successful candidate will thrive in an open working environment. The successful candidate will take a creative and company-wide approach to problem solving.
***Please note this position can be hybrid or remote***
- Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Nkarta products in development and to meet regulatory requirements
- Leads key activities of DS&PV, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks.
- Oversees serious adverse events handling, including individual case reviews, assessment of expectedness and relatedness, and collaboration with Medical Monitor and Regulatory on expedited reports, as appropriate.
- Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases and reviewing to ensure high quality data capture in the databases.
- Contributes to authoring and review of aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports, IB, etc). as well as the risk sections of the master ICF.
- Reviews and contributes to development of protocols and other clinical trial documents working with a cross functional group.
- Works with the CRO safety operations teams to organize, manage and maintain a highly compliant Pharmacovigilance system including contributing to SOPs as needed
- Participates in the drafting and implementation of pharmacovigilance contracts, agreements and budget, and oversee performance of drug safety operations among CROs.
- Reviews safety data exchange and/or pharmacovigilance agreement with business partners and accountable in ensuring compliance with safety data exchange activities.
- Reviews and/or contributes to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs.
- Provides expert safety guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.
- Assists in preparation of response to regulatory inquiries related to safety.
- Prepares training materials for internal and external safety presentations as applicable.
- Performs other duties as assigned.
- Oversight experience of global safety activities, operations, and risk management strategies in pre and post marketing environments.
- Expert knowledge on FDA safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GVP) and other applicable safety and regulatory guidance documents.
- Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
- Strong experience with drug safety databases such as Argus, and electronic data capture (EDC) systems, MedDRA and WHO Drug dictionary coding.
- Rational approach to issues and their business implications, good problem solving and decision-making skills.
- Team player in multifunctional, multicultural, growing organization.
- Strong interpersonal skills including verbal and written communication.
- For Sr. Director: 10+ years and for Director 5-10 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies)
- Prior leadership experience managing teams and budgets highly desired
- Experience in cellular therapy highly desired
- Experience in immunology, immunotherapy or biological therapy development
- MD, RN, BSN, PA, NP or PharmD
A reasonable estimate of the current salary range for this position is $215,000 - $320,000. 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 job location and 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.
Working at Nkarta Inc.
The 160+ 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