Executive Director / Head, Clinical Operations

WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. The Company has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries).

Our team has extensive experience in the discovery and development of mRNA medicines, as well as design and utilization of lipid-mediated drug delivery systems. This combination of in-house expertise, innovative spirit, and passion for what we do, uniquely positions us to catalyze the next generation of mRNA medicines.

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA 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.

The Role:

Reporting to the Senior Vice President, Operations, the Executive Director of Clinical Operations is responsible for oversight of the overall clinical operations strategy, execution and management of clinical studies and their associated trial master files in the Arcturus portfolio. Key activities include strategy and planning towards milestones, managing the supporting clinical operations team, hands-on management of external vendors, driving critical path activities, proactively identifying issues and resolving conflicts. Additionally, the Executive Director, Clinical Operations will be responsible for programmatic resource and financial planning / forecasting and budget management. He or she will be the primary contact for the Project Team and will work closely with key functions both within and outside of Arcturus to ensure that key project deliverables are met on time and within budget.

Responsibilities:

• Collaborate with internal and external stakeholders to ensure strategic alignment of objectives, develop operational strategy, and execute clinical programs on time and within budget
• Develop collaborative relationships with external partners while overseeing and directing deliverables
• Ensure cross-functional, integrated study plans are available from study start-up to reporting
• Lead internal cross-functional study team meetings, as needed
• Review and approve study-related materials including protocols, informed consent forms, monitoring plans, site training materials, EDC/case report forms, study, lab and pharmacy manuals, data management plans, monitoring reports, etc.

• Oversee study-related activities including site identification and selection, enrollment models, clinical supply planning and drug supply, lab kits, investigator and vendor meetings, development of systems, review of data during the study, data cleaning, database lock, etc.
• Proactively identify project risks before they arise and develops contingency plans; escalate issues related to quality, timelines, and budget and provide recommendations 
• Ensure global study is implemented according to the protocol and in compliance with local & international ICH, GCP and company policies and procedures
• Monitor clinical study site activities and visit sites as needed
• Collaborate with legal and finance (and others as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, contract negotiation and development, clinical trial agreements, clinical research organization agreements, payment terms, milestones, etc.)
• Support the tracking of trial budget(s) working closely with the appropriate partners

• Oversee clinical operations resource and budget planning / forecasting
• Directly mentor, coach and develop clinical operations staff
• Develop functional systems, processes, tools and SOPs to support departmental needs
• Develop and maintain strong, collaborative relationships with key stakeholders within Arcturus
• Ensure trial master files for each study are kept current and complete
• Support and lead inspection and inspection readiness activities as needed

Requirements:

• At least 15 years of experience working in a clinical operations role, with at least 8 years in study management and 5 years in people management
• Experience working on rare disease or vaccine studies (ideally Phase III experience in vaccine studies)
• Inspection experience highly desired
• Proven track record of leadership and success at the Senior Director level
• Advanced degree preferred or Bachelor’s in a science-based subject
• Relevant experience in global setting
• Solid understanding of drug development
• Good project management and organizational skills, attention to detail
• Team player who is willing to roll up sleeves to get the job 
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Excellent verbal and written communication skills
• Must have experience in CRO oversight

WHAT WE OFFER

Anticipated salary range for candidates that will work in San Diego is $220,000 - $333,500

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is a multi-state employer, and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

An exciting opportunity to join a company that offers:

• Catered lunches
• Free variety of snacks and beverages
• Referral Bonuses
• On Campus Gym
• Company sponsored FUN events