What are the responsibilities and job description for the Sr. Director, Regulatory Affairs position at Artiva Biotherapeutics?
About Artiva
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary
The Sr. Director, Regulatory Affairs is responsible for providing autoimmune disease and oncology focused regulatory affairs expertise and leadership for clinical development of Artiva therapeutics worldwide.
Key Responsibilities
- Serve as the regulatory affairs expert on product development teams.
- Provide analysis from a regulatory affairs perspective of clinical development strategies.
- Provide high quality regulatory affairs input and critical review of documents in support of submissions to regulatory authorities worldwide.
- Provide assessments for regulatory success based on a thorough understanding of regulatory risks and mitigations.
- Provide input for labeling requirements
- Contribute to negotiation strategy and planning for interaction with regulatory authorities.
- Keep abreast of regulatory affairs developments in autoimmune disease and oncology.
- Management of regulatory affairs consultant deliverables.
- Management of adverse event reporting to regulatory authorities.
- Lead development of annual reports to regulatory authorities.
Qualifications
- A minimum of 10 years in the biotechnology industry with at least 5 years in Regulatory Affairs.
- Bachelor's degree required, preferably in a scientific field.
- Experience with autoimmune disease and oncology related regulatory submissions.
- Flexible, detail-oriented, and willing to work in a dynamic and fast-paced environment while managing multiple priorities.
- Show strong initiative and drive; must be an organized self-starter.
- Ability to work independently, within a group setting, and interact effectively across cross-functional departments.
- Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
- Excellent listening skills.
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
· A beautiful facility
· An entrepreneurial, highly collaborative, and innovative environment
· Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Artiva Biotherapeutics is an equal employment opportunity employer.
Base Salary: $230,000 - $265,000. Exact compensation may vary based on skills and experience.
Salary : $230,000 - $265,000