Head of Data Management

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Head of Data Management Full Time San Diego, CA San Diego, CA, US 30+ days ago Requisition ID: 1274 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 (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. 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 (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 including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation. 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 OPPORTUNITYThe Head of Data Management plays a key role in development of data management strategies including outsourcing, oversight strategies, standards, processes. The Head of Data Management will be the subject matter expert related to data management activities across vaccines and the rare diseases portfolio. Reports to Vice President of Biostatistics or designee.WHAT YOU WILL CONTRIBUTEPlay key role in development of data management strategies for the organization Identify external resources for consultationManage internal and external resources, review CRO budgets, participate in vendor selection, and provide CRO oversightRepresent the company with regulatory agencies and drive the data management regulatory strategies for clinical trials and global regulatory submissionsResponsible for data management components of regulatory submissions and ensure consistency across programsIdentify gaps, set priorities , provide value added solutions to problems and support clinical trial designs and approach for data driven decision framework Lead and oversee data management support for clinical development of multiple compounds and projects within Arcturus portfolioClosely collaborate with other stakeholders such as regulatory affairs, pharmacovigilance, medical, drug safety, clinical operations, biostatistics, statistical programming, and clinical pharmacology.Keep abreast of key developments in data management and statistics, clinical development, regulatory requirements and guidance, and industry standards for data collectionAuthor data management SOPs and contribute to review of all other departmental SOPs and provide training on data management topicsWHAT WE SEEKMinimum of 10 years’ total experience in drug development environments, including hands on data management roles as well as leading appropriate function/departmentB.S. (or higher) degree in a Science or related field is preferred, however extensive work experience (over 15 years of relevant experience) may be considered as equivalent Demonstrated application and working knowledge of ICH GCP and relevant regulations for pharmaceutical industry (21 CFR Part 11 Electronic Records; Electronic Signatures, Privacy rules (HIPAA), MHRA/EMA/FDA regulatory body inspections)Thorough knowledge of using data management technologies and CDISC data standardsExperience in managing global trials , especially vaccines and rare disease areas clinical trials Detail oriented with a thorough knowledge of clinical and data management operationExcellent interpersonal, leadership, and communication skillsStrong collaborative skills and ability to work with a cross‐functional teamStrong project management, analytical and organization skillsProven ability to develop and maintain successful working relationships with internal and external stakeholders EDUCATIONB.S. (or higher) degree in a Science or related field is preferred, however extensive work experience (over 15 years of relevant experience) may be considered as equivalent WHAT WE OFFERAt Arcturus Therapeutics, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Our total rewards package includes: Full range of health benefits including Medical, Dental & Vision with 100% EMPLOYER PAID premiums for employee and family!401k MatchEmployee Stock Purchase Program (ESPP)Competitive salaries and bonus plans plus equity via Stock OptionsCatered lunchesFree variety of snacks and beveragesHealth and Wellness programs$100 Anniversary cash awards with opportunity to increase to $2000!On Campus Gym Company sponsored FUN eventsThe anticipated salary range for candidates who will work in San Diego is $165,000.00 to $200,000.00. 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 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. Arcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.