Founded in 2013 and based in San Diego, Arcturus Therapeutics, Inc. (NASDAQ:ARCT) is an RNA medicines company with enabling technologies – UNA Oligomer chemistry and LUNAR® lipid-mediated delivery. Arcturus’ diverse pipeline of RNA therapeutics includes programs pursuing rare diseases, Hepatitis B, non-alcoholic steatohepatitis (NASH), cystic fibrosis, and vaccines. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of RNA medicines including small interfering RNA, messenger RNA, replicon RNA, antisense RNA, microRNA and gene editing therapeutics. Arcturus owns LUNAR® lipid-mediated delivery and Unlocked Nucleomonomer Agent (UNA) technology including UNA Oligomers, which are covered by its extensive patent portfolio (140 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ proprietary UNA technology can be used to target individual genes in the human genome, as well as viral genes, and other species for therapeutic purposes. Arcturus’ commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, Synthetic Genomics Inc. and the Cystic Fibrosis Foundation. For more information, visit www.Arcturusrx.com, the content of which is not incorporated herein by reference.
Arcturus Therapeutics, Inc. is presently recruiting outstanding candidates with experience in the field of RNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients. Please email your resume to Careers@ArcturusRx.com.
Senior Scientist, Translational Biology (Immunology)
Arcturus Therapeutics is seeking an innovative and highly motivated Immunologist to join our Translational Biology team. Our successful candidate will help build a new class of immune-therapy products based on Arcturus’s proprietary Lipid Nano Particle (LNP) nucleic acid delivery platform and must have strong expertise in immunology and effector cell biology.
In this role, you will be responsible for leading oncology and immunotherapy projects and identify and interrogate immunomodulatory target pathways using cutting-edge technologies and novel approaches to enrich our company pipeline. You will be responsible for supporting existing immunology-based programs including cancer vaccines and immunotherapy targeted projects.
Our successful candidate will thrive in a proactive, fast-paced ‘can-do’ culture and enjoy collaborating across the full range of development activities and project teams for the ground-breaking, mRNA-based new drug candidates targeting rare disease. Our candidate should have extensive laboratory research experience and a desire to continue in a laboratory-focused role with a high level of experimental vigor and quality. Prior experience with rodent tumor immunotherapy models, nucleic acid vaccine development, cancer immunology and immunotherapy is strongly preferred.
- PhD with 10+ years’ experience with an emphasis on target ID and validation in cancer cell biology and immunology
- Expertise in current technology practices in cancer biology and immunology is required.
- Experience with in vivo rodent cancer and immunotherapy models with demonstrated proficiency in immunological assays to assess effector cell function is required.
- Experience in cancer target and immunotherapy drug discovery and development is preferred
- Develop and conduct immunological and cellular bioassays to support development of clinical candidates.
- Demonstrated experience in T-cell biology, innate immunity, and a deep understanding of the host immune response against cancer.
- In-depth knowledge of setting up T-cell activation assays, manipulating dendritic cells and B-cells to present antigens using ex vivo derived immune cells or tumor-infiltrated lymphocytes.
- Ability to independently design experiments, make detailed observations, analyze data, interpret results and deliver timely results is required.
- Excellent presentation and oral and written communication skills is required.
- Proven ability to prepare precise technical summaries and protocols and maintenance of appropriate documentation is required.
- Previous experience is drug discovery is preferred.
- Ability to prioritize and work in a fast-paced and diverse environment is required.
- Strong sense of urgency, initiative, ethics/integrity and innovation is required.
Vice President, Clinical Development, Rare Disease
Arcturus is seeking an experienced physician scientist to lead drug development for our mRNA-based programs. In this role, you will have direct medical responsibility for our rare disease development programs, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring in close collaboration with Arcturus’s internal research and platform organizations and relevant external pharmaceutical partners. Reporting to the Chief Scientific Officer, the VP will work collaboratively with other senior and functional leaders to ensure integrated development strategies, and to drive portfolio prioritization. He/she will maintain a blend of strategic and operational accountabilities and will serve as an Arcturus spokesperson in external interactions with health authorities, at scientific meetings, and working with collaborators.
Our successful candidate will thrive in a proactive, fast-paced ‘can-do’ culture and enjoy collaborating across the full range of development activities for the ground-breaking, mRNA-based new drug candidates targeting rare disease. As a technically adept and agile drug developer, the VP will play a central role in advancing and expanding the Company’s already exciting and diverse portfolio of products.
- Provide clinical leadership for rare drug discovery and development, serve as top representative for clinical development / medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff) in multiple therapeutic areas.
- Lead the design clinical development plans, study protocols and interpret clinical study data, including review of the pre-clinical package.
- Lead the implementation of innovative clinical trials for novel drug candidates, from translational stage through pivotal trials and registration with adherence to cGCP and FDA Regulatory compliance.
- Serve as cross-functional leader on all medical and clinical work streams including clinical pharmacology, statistics, clinical operations, regulatory affairs, biometrics, and translational medicine.
- Provide strategic consultation and guidance to external and internal subject matter experts with regard to go/no-go development decision criteria on significant clinical components and implications.
- Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
- Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues. Manage timely reporting of safety signal to regulatory authorities and the generation of clinical study reports.
- Lead clinical sections of regulatory documents (e.g., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Clinical Advisory Board meetings.
- Manage the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts). Review documents including IBs, informed consent forms and other documentation.
- Represent the Company externally to Investigators and trial site administrators and serve as subject matter expert on all clinical and medical strategic initiatives.
- Maintain accountability for all relevant timelines and deliverables. Lead clinical team to secure global regulatory approvals for pipeline products.
- Communicate regularly and effectively with senior leaders across the R&D organization.
- Evaluate the balance between outsourcing and in-house approaches for the various Clinical Development needs, working closely with Clinical Operations to make recommendations for Arcturus’s strategy in this regard.
- MD or MD/PhD plus a minimum of 10 years of demonstrated experience in clinical research in rare disease as well as significant knowledge and experience in the design and execution of clinical trials.
- Demonstrated track record in leading cross-functional teams and work streams (e.g., biostatistics, regulatory, pre-clinical pharmacology and pharmaceutical sciences).
- Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills.
- Marked proficiency in clinical/medical writing.
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
- Experience in early-stage programs.
- Experience in leading the selection and oversight of CROs and other vendors.
- Experience working with Senior Executive Team, Board members, KOLs, regulatory bodies, and investors.
- Experience overseeing activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct.
- Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States and Europe.
- Displays creative, capable and relentless problem-solving skills.
History of taking bold, but calculated risks.