Position Title Vice President, Regulatory Affairs
Location South San Francisco, CA
Reports to Chief Medical Officer
Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, early-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer.
Nkarta is hiring an experienced Regulatory affairs leader who will continue to grow a high-performing Regulatory function for a fast-growing biotechnology company. The successful candidate will provide leadership in developing multiple cellular immunotherapy products across Nkarta’s deep pipeline based on a novel and proprietary platform of allogeneic off-the-shelf genetically engineered cells with broad applications in oncology. Nkarta is a clinical stage company with one candidate in Phase 1 and the second with approved INDng enrollment shortly. The third pre-clinical program is co-developed with CRISPR therapeutics. Nkarta plans to submit an IND every 1-2 years for additional products in the pipeline.
The successful candidate will work closely with the chief medical officer, the head of technical operations and the rest of the executive team to develop the long term global regulatory strategy and vision for Nkarta cell therapy products. This includes leading interactions with health authorities, leading and contributing to submission management activities, and creating fit for purpose regulatory function processes including appropriate build out of the regulatory team.
Reporting to the Chief Medical Officer, the candidate will leverage broad knowledge and expertise to work collaboratively with colleagues in ensuring 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 candidate will take a creative and company-wide approach to problem solving and provide Nkarta colleagues with the information and innovative tools required to prepare successful and high-quality regulatory submissions, creating a seamless environment for all stakeholders.
· Lead the regulatory function and enable rapid and successful product development, approvals, and life-cycle management.
· Establish the long-term strategy for the regulatory team, activities, and planning in accordance with an established road map, with an expectation to scale-up efficiently and rapidly.
· Provide strong cross-functional leadership for global filings
· Build the regulatory function, build, and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members.
· Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both Nkarta and health authority standards.
· Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
· Responsible for continuous improvement of systems and processes, including internal training, for the regulatory department and cross functional teams
· Ensure inspection readiness efforts for regulatory activities and files
· Manage regulatory budgets and vendors
· Maintain current expertise in regulatory trends and operations
· Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science
· Embrace and thrive in a team-oriented company, setting up projects and team-members for success
· Ability to critically evaluate opportunities and assess and articulate risks to enable corporate decisions
· Ability to prioritize responsibilities and meet deadlines
· Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department to ensure successful scalability as the programs grow
· Demonstrated proficiencies in leading successful health meetings and interactions
· Independently motivated, excel at driving execution, detail oriented
· Excellent analytical and problem-solving skills
· Excellent organizational skills to multi-task in a fast-paced environment with changing priorities
· Demonstrated ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment
· Excellent verbal and written communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, and senior management and external agencies
· Excellent cross-functional leadership and project management skills.
· Ability to work at the strategic and tactical level and comfortable shifting back and forth
· Enthusiastic positive upbeat can-do attitude to the office; doesn’t take themselves too seriously, has a sense of humor
· Minimum 10-15 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies)
· Extensive regulatory management experience and in developing innovative regulatory solutions.
· Track record of success in gaining approval of original NDAs, MAAs and / or BLAs (experience with orphan or rare diseases is highly desired)
· Experience with cell and gene therapy products/ complex biological products
· Experience with oncology products
· Success in fostering effective team spirit.
· Experience in leading multidisciplinary teams
· Relevant knowledge in CMC, clinical and nonclinical science
· Knowledge expert regarding global regulatory submission standards and publishing best practices.
· Knowledge expert regarding global cell therapy product development guidelines
· Experience with process design and improvement and with developing systems from the ground up.
· Graduate degree required, PhD, MD or Pharm D. degree preferred.
Nkarta is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protect
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 101 are in process; 019 will begin in H2 2021. 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 good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.
Working at Nkarta
The 100+ 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