Nkarta Therapeutics is a publicly traded (
Location: South San Francisco, CA
Reports to: Chief Medical Officer
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.
· 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.
· Healthcare professional degree required
· 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