Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is an RNA medicines company with enabling technologies – LUNAR® lipid-mediated delivery, Unlocked Nucleomonomer Analog (UNA) chemistry, STARR technology™ – and mRNA drug substance along with drug product manufacturing. Arcturus’ diverse pipeline of RNA therapeutics includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (177 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc. and the Cystic Fibrosis Foundation. For more information visit www.Arcturusrx.com.
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.
Public Relations & Marketing Associate
We’re looking for a PR & Marketing Associate to join our growing team. This is an excellent entry-level opportunity! In this role, you will create PR/Marketing collateral, assist with website design, graphics, and plan publicity strategies and campaigns. You will be responsible for research, asset creation and organization to support corporate investor relations activities.
This is a full-time on-site and temporary position with potential to hire.
- Create PR & Marketing collateral including brochures, pamphlets, newsletters, and drafts.
- Plan publicity strategies and campaigns.
- Assist with sponsorship evaluations, asset tracking, and logistics.
- Analyze media coverage. Edit video clips/TV promotions.
- Research articles/media on mRNA/RNA and extract information from multiple data sources.
- Assist with corporate website maintenance/design, using appropriate specs/size creations for modifications.
- Assist with slide deck design and updates. Coordinate materials for presentations and media outreach.
- Manage daily administrative tasks for the department.
- Bachelor’s degree in business, science or other related fields.
- Exceptional presentation and written/verbal communication skills.
- Ability to manage workload with minimal supervision.
- Strong knowledge of Microsoft Office: Excel and Powerpoint needed.
Head of Respiratory Pharmacology
Arcturus Therapeutics is seeking an innovative and highly motivated Respiratory Pharmacologist to join our team and take the lead on our Cystic Fibrosis program. The successful candidate will help build a new class of lung targeted products based on Arcturus’s proprietary Lipid Nano Particle (LNP) nucleic acid delivery platform and be the representative of our lung/respiratory programs to investors, partners, the CF Foundation. The successful candidate must have a track record of experience in identifying, validating and advancing aerosolized drugs into the clinic.
The 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 respiratory diseases. This is a Director/Vice President-level role and our candidate should have extensive experience in the development of aerosolized drug delivery systems with a proven track record of progressing programs from preclinical to clinical stages. The successful candidate must have an understanding of the spectrum of different nebulizers. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify and troubleshoot issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
- Lead Arcturus’s inhaled drug discovery and development platform in the respiratory therapeutic area to progress products into the clinic.
- Collaborate across multiple internal teams to identify and interrogate respiratory target pathways using novel approaches to enrich our pipeline.
- Lead programs and projects addressing key scientific questions, execution of research plans, risk assessments and data-driven decisions.
- Provide strategic, scientific leadership in the design, execution, analysis and interpretation of a broad range of in vitro, in vivo and ex vivo experiments for drug discovery.
- Effectively identify, develop and manage collaborators (academic, industrial partners and CROs).
- Critically analyze and interpret data, effectively document and communicate results to diverse audiences, internally and externally.
- Build and develop future talent by providing mentorship and regular coaching to team members.
- PhD with 15+ years’ experience in the respiratory field with an emphasis on target ID, validation, and preclinical drug development for respiratory-based disease.
- Experience with in vivo aerosolized drug delivery optimization. Understand FDA hurdles for aerosolized -delivery drug program.
- Understanding of classical pharmacological principles and drug discovery process, in order to support assessment of potency, efficacy and contribute to predictions of human efficacy.
- Experience with animal models of respiratory disease.
- Understanding of biology of the lungs/lung physiology
- Design and interpret in vivo pharmacology studies to evaluate the activities of drug candidates, investigate their mechanisms of action, and explore novel therapeutic hypotheses.
- Experience with pharmacodynamics endpoints, such as biomarkers or in vivo imaging, is a plus.
- Investigate, select, and/or develop new methods and technologies for project advancement; monitor work-flows to enable execution of studies.
- Manage in vivo pharmacology research in a matrixed environment, as well as external academic collaborations and an extensive network of CROs.
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Excellent presentation and oral and written communication skills is required.
- Ability to prioritize and work in a fast-paced and diverse environment is required.
Clinical Trials Manager
We’re looking for a Clinical Trials Manager to join our growing team. This position will be responsible for the operational management and the oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Providing oversight of the CRO and other third-party vendors on the assigned study. The Clinical Trial Manager will work closely with a Project Leader, Pharmacovigilance, Regulatory, etc., and will report into the Clinical Operations Manager.
- Assisting in the identification and hiring of appropriate CROs and third-party study vendors
- Assisting with CRA and third-party vendor training on protocols and practices
- Developing and maintaining good working relationships with investigators and study staff
- Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Identifying, selecting, and monitoring the performance of investigational sites for clinical studies
- Investigating queries, monitoring discrepancies
- Managing the investigational product (IP) accountability and reconciliation process
- Negotiating and managing the budget and the payments
- Overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with the study protocol and in accordance with the scope of work; identifying areas of concern and escalating to Clinical Operations Manager
- Performing clinical data review of data listings and summary tables, including query generation
- Performing an initial review of CRO and other third-party study vendor invoices
- Planning and conducting investigator meetings
- Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining the appropriate action in conjunction with the study team
- Reviewing or approving of IP release packages
- TMF maintenance
- Tracking and reporting on the progress of study including site activation, patient enrollment, monitoring visits
- Writing or contributing to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Other duties as assigned
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field required
- A minimum of 6 years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required
- A minimum of 2 years of clinical trial management is required
- Working knowledge of GCP/ICH guidelines and the clinical development process
We’re looking for a Project Coordinator to join our growing team. This individual will be responsible for supporting project planning, scheduling, monitoring, and reporting for development programs. The role is an essential interface between the Global Program Management Office, Finance, Department Leads, as well as other key stakeholders to manage, track and communicate the status of all projects and programs.
- Supporting project planning, scheduling, monitoring, and reporting for development programs.
- Facilitating the definition of project and program outlines, goals, tasks, and resource requirements.
- Developing project scope and objectives involving all relevant stakeholders.
- Developing and maintaining detailed timelines for project and program activities utilizing Microsoft Project.
- Tracking and helping to communicate project issues (not responsible for resolution).
- Routinely reviewing project and program timelines and budgets with cross-functional team members and revising as needed.
- Providing regular project plan updates and status reporting on financial and delivery progress, including executive dashboards.
- Working closely with the Finance team to support cost variance analysis and proactively communicating any budget or resource limitations.
- Monitoring risks, issues, assumptions, dependencies, and actions.
- Monitoring changes in project scope, schedule, and costs.
- Collaborating with a diverse workforce within a matrix environment and communicating effectively to obtain and synthesize project and program requirements from stakeholders.
- Supporting status reviews meetings among program team members.
- Identifying key objectives for meeting agendas, capturing accurate and relevant minutes and actions items. Ensuring follow up on action items.
- Creating and maintaining project and program documentation, including preparation for stage-gate reviews.
- Bachelor’s Degree required, preferably in the fields of Science or Life Sciences.
- 2-5 years of experience in Biotech/Pharma with proven project coordination experience working with multiple stakeholders across functions.
- Must possess strong communication and collaboration skills.
- Basic understanding of project management, scheduling and cost tracking.
- Comfortable working in a fast-paced, challenging, changing environment.
- Highly skilled and proficient utilizing Microsoft Project and related tools like Microsoft Office and SharePoint.
- Team player – work cooperatively and effectively with others to set goals, resolve problems, and make decisions which are timely and in the best interests of the organization.
- Excellent organizational skills and ability to work on a number of projects with tight timelines is required.
- Creative/Innovative – able to develop new and unique ways to improve and streamline processes.
Clinical Project Manager
We’re looking for a Clinical Project Manager to join our growing team. This individual will be responsible for the support of clinical development timeline deliverables with a clear understanding of functional interdependencies and critical path activities. Accountable for supporting various clinical development functional areas on projects in a timely and cost-effective way. The Clinical Project Manager will work closely with the Clinical Study Teams to manages vendors, consultants, and budgets through contractual agreements of various projects
- Supporting the Clinical Study Teams in project planning, including timelines, budget, and resource management, development of team agenda and minutes with action items.
- Communicating clinical study status and issues to ensure Clinical Study Team milestones and deliverables are meeting.
- Facilitating sub-team meetings and organizing ad hoc working groups as needed to move clinical activities forward.
- Providing support to team members to objectively assess and resolve project management issues by identifying root causes as opportunities to improve project effectiveness; coaching team members to be proactive in resolving issues.
- Understanding of the cost drivers and accountable for the development, management, and reconciliation of overall clinical study budget(s).
- Actively contributing to Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs, Wls, department level training and clinical study metrics.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- BA/BS or equivalent degree in scientific discipline.
- A minimum of 5 years, of clinical trials research experience/clinical project management in a pharmaceutical / biotechnology company or CRO industry.
- Demonstrates technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing).
- Excellent attention to detail and accuracy in work with proven ability to work independently, with a high level of integrity on multiple tasks Strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality.
- Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail.
- Ability to accommodate shifting priorities, demands and timelines.
- Excellent knowledge and skill with Microsoft Office Software (Excel, Word, Power Point, and especially Microsoft Project).
- Working knowledge of ICH GCP as relates to clinical trial management.
- Superior understanding of financial planning and managing clinical program budgets.
- Experience at/or oversight of clinical research vendors (CROs, central imaging vendors, IXRS, etc.).
- Experience in Rare Disease therapeutic areas (highly desired, but not required).
Scientist I, Analytical Development
The Scientist I, Analytical Development will be responsible for the development of analytical methodologies and supporting the routine analytical characterization of RNA-based drug substances, intermediates and formulated drug products to support an emerging research pipeline focused on treating rare diseases. The candidate will also act as a mentor/coach to developing analytical research associates and interns.
- Develop new analytical methodologies to characterize nucleic acid based API and drug product formulations using various chromatographic and spectroscopic techniques such as HPLC, LC-MS, LC-MS/MS, UV-Vis, Fluorimetry and as well as other specialty instrumentation including but not limited to particle sizers, KF, osmometer, etc.
- In close collaboration with the broad team of RNA, chemistry and formulation scientists, design and perform laboratory research experiments needed to support RNA, chemistry and formulation process development efforts
- Lead in optimization and trouble-shooting of the existing analytical methodologies to characterize RNA-based API and drug product formulations
- Assist with routine analytical testing for formulation development, in-process and stability testing using the above techniques
- Maintain proper documentation of all experimental procedures and results
- Write/revise analytical methods, prepare technical reports and presentations which summarize procedures, study results and provide data interpretation
- Present scientific results and observations to colleagues, management and clients at internal and client meetings
- Provide necessary training, guidance and oversight for analytical research associates and interns
- Perform other duties as needed
- Masters degree in Analytical Chemistry or in related discipline with 5+ years of relevant work experience or Ph.D. in a related area of science with 0-2 years of relevant experience.
- Analytical Chemistry or in related discipline with 5+ years of relevant work experience or Ph.D. in a related area of science with 0-2 years of relevant experience.
- Solid knowledge and hands-on experience with HPLC, LC-MS and LC-MS/MS instrumentation and applications. Familiarity with instrumentation software, including Chemstation, ECM OpenLab, Chromeleon and Xcalibur software is a plus.
- Expertise in multiple analytical techniques such as UV-Vis, Karl Fischer, fluorescent plate readers, osmometers, viscometers etc.
- Knowledge of biochemistry techniques such as qPCR and various gel-based assays (e.g. Western blot) is a plus
- Experience with the analytical characterization of nucleic acid-based therapeutics is a plus.
- Familiarity with development, qualification, and validation of analytical procedures
- Ability to apply existing knowledge and experience to solve standard analytical problems without instruction and receive guidance on new assignments or more complex problems from a senior team member or supervisor
- Ability to think critically and creatively, have great attention to details and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
- Comfortable working in a highly innovative environment and strong ability to cope with change.
- Responds well to the scientific challenge and applies significant rigor to their own work.
- Will scientifically challenge others in a constructive manner and demonstrate exceptional team working skills.
- Excellent verbal and written communication skills
Research Associate / Senior Research Associate, Drug Discovery
We are looking for a Research Associate / Senior Research Associate to join our growing team. The Research Associate will conduct hands-on experiments in the Drug Discovery department with a wide variety of cellular biology, molecular biology, and biochemistry techniques. This person will be expected to complete scientific and technical tasks on aggressive timelines and to work as part of a team on varied projects with changing priorities. This position requires excellent communication skills, an outstanding ability to troubleshoot technical issues, a superior ability to plan and carry out experiments independently, and to work with complex instrumentation and software. Exact title and responsibilities will be commensurate with experience.
- Coordinate with team members to define experiments, plan to achieve objectives and execute work with limited supervision.
- Process in vivo samples for molecular biology assays (protein, RNA and DNA analysis).
- Grow, maintain and transfect mammalian cells.
- Perform initial analysis of experimental data and interpret immediate outcomes.
- Troubleshoot routinely technical problems and perform ordinary/extraordinary equipment maintenance.
- Contribute to the development of novel assays.
- Demonstrate clear communication and present scientific results in department meetings.
- Order and maintain reagents and lab supply.
- Ability to keep organized data and records.
- Performs other duties as assigned.
- Bachelor/Master degree in cellular biology, molecular biology, biochemistry, or a related field.
- 3-5 years of relevant laboratory experience in academic or industrial setting.
- Strong experience with micropipetting, aseptic/sterile technique and plating.
- Experience with BSL-2 procedures.
- Experience with animal tissue and blood samples for DNA, RNA and protein isolation.
- Experience with mammalian cell culture and transfection techniques.
- Experience with protein characterization assays (BCA, SDS-PAGE, Western Blot, In Cell Western, and ELISA).
- Experience with nucleic acid characterization assays (PCR, TaqMan qPCR, and QuantiGene).
- Strong computer skills, including MS Word, Excel, PowerPoint and data analysis software (Prism).
- Experience with high throughput screening is a plus.
- Experience with lipid nanoparticle delivery systems is a plus.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Arcturus Therapeutics. To protect the interest of all parties involved, we will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Arcturus Therapeutics from recruiters do not constitute any type of relationship between the recruiter and Arcturus Therapeutics and do not obligate Arcturus Therapeutics to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.