REGULATORY AFFAIRS HEAD, ONCOLOGY

Location: San Mateo or San Diego, CA 

Rakuten Aspyrian is looking for a Regulatory Affairs Head who will be a key leader of our management team. The Regulatory Affairs head will work directly with Rakuten Aspyrian’s functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.  The candidate should have a B.S./M.S. with at least 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization.  Responsibilities will include executing US /OUS regulatory project plans in collaboration with Rakuten Aspyrian management, clinical, CMC and device groups as well as regulatory consultants, and CROs. Additional responsibilities include managing and overseeing all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual reports

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CLINICAL QUALITY MANAGER

Location: San Diego, CA

Rakuten Aspyrian is seeking a Clinical Quality Manager to manage various clinical quality related activities in coordination with clinical team leadership.  The Clinical Quality Manager will ensure clinical processes are conducted in accordance with applicable regulations and guidances, ensure maintenance and audit of clinical trial documents, and assist in the writing and review of Clinical Quality-related SOPs. The Clinical Quality Manager will also assist in identifying non-conformances during clinical trial conduct, provide risk mitigation strategies and feedback, and recommendations to facilitate ongoing process improvement. The candidate must have a Bachelor's degree or equivalent in the life sciences or related field and minimum of 7 years of experience in clinical quality and process improvement.

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MEDICAL WRITER

Location: San Mateo, CA

Rakuten Aspyrian is seeking a Medical Writer to manage various writing activities in coordination with the Clinical/Medical team.  The Medical Writer will ensure consistency across documents, improve document quality, and provide guidance on writing style. The Medical Writer will also assist in writing and reviewing publications, abstracts, and clinical trial-related documents. The candidate must have a Bachelor's degree or equivalent in the sciences or writing discipline and minimum of 7 years of experience in medical writing.

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VICE PRESIDENT, CLINICAL DEVELOPMENT

Location: San Mateo, CA

Rakuten Aspyrian is seeking a VP of Clinical Development to be a key leader supporting strategy and operational implementation of clinical activities to support development of Rakuten Aspyrian's clinical assets.  The VP of Clinical Development will be a key participant of Development sub teams, with subject matter experts from key functions such as Translational Medicine, Regulatory Affairs, Medical Affairs, Biostatistics/Data Management, Pharmacovigilance, Quality Assurance, Business Development, and Commercial Operations. The VP of Clinical Development will also collaborate with the Chief Medical Officer, Business Development and the commercial team to develop a commercialization strategy which will include development of TPPs based on competitive assessment and target positioning, and will align the clinical development strategy with the commercial strategy. The candidate must have a MD or PhD degree and Oncology Board certification preferred.  The candidate must also have a minimum of 10 years experience of clinical development leadership in oncology with biopharmaceutical companies, including drug and device clinical development.

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CLINICAL SUPPLY CHAIN SPECIALIST

Location: San Diego or San Mateo, CA

The Clinical Supply Chain Specialist will be responsible for managing investigational drug, device, and ancillary supplies for assigned clinical studies, in coordination with Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The Clinical Supply Chain Specialist will be assigned at the study level, with the opportunity to manage multiple studies as the program size warrants. The ideal candidate will have 5+ years of experience in clinical supply chain management, with global experience preferred. This person will have an excellent understanding of the drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies. 

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ASSOCIATE MEDICAL DIRECTOR - USA 

Location: Regional - West Coast, Central, East Coast USA

The Associate Medical Director will be a key member of the Clinical Operations team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical consultation to company and project team members for clinical activities, and participate in new product development. The ideal candidate will have an MD, DO, or equivalent degree, hold an active MD &/or DO license, and have experience in medical, surgical, or radiation oncology. Additionally, a working knowledge of drug development process, GCP, ICH guidelines and FDA regulations as well as direct involvement as an investigator of clinical studies or direct experience in managing clinical operations is highly desirable. The Associate Medical Director may be located anywhere in the USA within a reasonable distance of a major airport, and will report to the Global Medical Director.

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CLINICAL SCIENTIST

Location: San Mateo, CA 

The Clinical Scientist will be a key member of the Clinical team with responsibilities to provide scientific support for clinical development activities, including implementation of scientific clinical strategy into trial design and coordination of clinical development activities related with clinical pharmacology. This role will be integral in facilitating successful and timely initiation and completion of the company’s clinical development programs. The Clinical Scientist will collaborate closely with Translational R&D, program management, clinical operations, biostatistics, data management, regulatory, and business development (life cycle management), as well as externally with Clinical Research Organizations, Clinical Sites, and Clinical Investigators. Additionally, the Clinical Scientist will support the development of scientific external relationships with key therapeutic opinion leaders (KOLs) and provide clinical input into safety and regulatory interactions. Extensive knowledge and hands on experience supporting clinical sciences in Oncology is required. The ideal candidate will be a self-motivated, creative, detail oriented, hands-on individual with an MD or PhD degree in life sciences, and at least 5 years of experience in the design, planning and execution of clinical studies. 

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SENIOR CLINICAL DATA MANAGER

Location: San Diego, CA 

Rakuten Aspyrian is looking for a Clinical Data Manager II or Senior Clinical Data Manager (CDM II/Sr. CDM) to provide oversight of, assist in the coordination of, and/or partake directly in the data management activities from study start-up, data processing, and database close-out in a paper or electronic environment for activities are conducted in-house or by CROs. The CDM II/Sr. CDM will have advanced knowledge of GCP/ICH standards, 21 CFR Part 11, and clinical trial processes as well as and be proficient in all aspects of data management from study start-up to study close-out, have experience in multiple Electronic Data Capture (EDC) environments, experience in Phase I, II, or III oncology studies, and experience in the oversight of CROs and 3rd party data vendors; in addition, the candidate will have experience with implementing CDISC CDASH CRF Standards and CDISC SDTM mapping, as well as knowledge of ADaM datasets and clinical trial SAS programming as related to data quality edit checks, data review, listings and reports, and tables/figures/listings (TFLs) is desired.

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REGULATORY AFFAIRS MANAGER

Location: San Diego, CA 

Rakuten Aspyrian is looking for a Regulatory Affairs Manager who will be responsible for supporting the development and implementation of regulatory strategies with a goal to ensuring timely clinical study starts and execution, CMC development, and BLA readiness for Rakuten Aspyrian’s biologic/drug combination therapies.  The Regulatory Manager will work closely with other functions of the company, including Quality Assurance, Clinical Affairs, Supply Chain, CMC, and Program Management.

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SENIOR CLINICAL TRIAL MANAGER

Location: San Diego, CA 

The Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.

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GLOBAL MEDICAL DIRECTOR, ONCOLOGY

Location: San Mateo, CA 

The Global Medical Director Oncology will provide scientific leadership and support for compounds in various stages of clinical development as well as approved products within a therapeutic area. This role will provide clinical expertise and strategic insights to help shape and form the overall development strategy for Rakuten Aspyrian’s oncology portfolio. The Global Medical Director will take leadership in taking responsibility site selection, medical oversight of the study and overseeing the Associate Medical Directors and Field Clinical Trainers.

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MANUFACTURING ASSOCIATE I - CELL CULTURE

Location: San Diego, CA 

Rakuten Aspyrian is currently looking for a highly motivated individual to support cell culture process development, manufacture, and technology transfer to CMOs.  This candidate will join Rakuten Aspyrian’s CMC team focusing on various aspects of upstream cell culture process development, process characterization, technology transfer and research material generation.  In addition, the ideal candidate will be familiar with processes related to the development, characterization and manufacture of antibody drug conjugates (ADCs).

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SR DOCUMENT QC & SYSTEMS ADMINISTRATOR

Location: San Diego, CA 

As a key member of the quality team, the Senior Document QC and Systems Administrator will be responsible for the execution of document QC processes, controlled document processes, and training processes. The position requires an extremely high attention to detail, hands on experience managing document control processes, and experience in QC review of regulatory submission documents.

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ASSOCIATE MEDICAL DIRECTOR - EUROPE

Location: Western Europe 

Rakuten Aspyrian is building its Medical team to support its ongoing and upcoming clinical studies, including a global Phase III clinical study. The Associate Medical Director will be a key member of the Clinical Operations team with responsibilities to support Rakuten Aspyrian’s current clinical development program, provide medical consultation to company and project team members for clinical activities, and participate in new product development. The ideal candidate will have an M.D., D.O. or equivalent degree, hold an active M.D. or D.O. license, and have experience in medical, surgical, or radiation oncology. 

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RECRUITER

Location: San Mateo, CA

Rakuten Aspyrian is growing rapidly to support the next stages of development of our technology. We are looking for an accomplished Recruiter to join and build our team in our San Francisco Bay Area office. The Recruiter will provide an innovative best-in-class candidate experience and quality support to our Talent Acquisition team.

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JANITORIAL TECHNICIAN

Location: San Diego, CA

This position serves to maintain the facility in a neat and orderly fashion. The qualified applicant will maintain the kitchen, printer areas, conference rooms, dining area and bathrooms.

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DIRECTOR OF REGULATORY AFFAIRS

Location: San Diego or San Mateo, CA

The Director of Regulatory Affairs will be responsible for working with Rakuten Aspyrian development teams to implement global regulatory affairs strategy for assigned company projects with the goal of ensuring timely clinical study execution, CMC development, and BLA readiness for our biologic/drug combination therapies. Responsibilities will span pre-IND through post-approval phases of development. This individual will interact with regulatory health authorities in all countries where Rakuten Aspyrian conducts clinical studies and/or intends to market a product. The Regulatory Affairs Director will work closely with other functions of the company, including quality assurance, clinical affairs, clinical development, pharmacovigilance, medical affairs, CMC, regulatory operations, and project management.

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MANAGER FP&A AND ACCOUNTING

Location: San Diego, CA

The Manager, FP&A and Accounting will be responsible for developing and managing the Financial Planning & Analysis (“FP&A”) system and function. In addition, they will be performing balance sheet account reconciliations, reviewing international subsidiary accounting and consolidations, and other accounting functions. Ideal candidates will have at least 3 years of public accounting experience and three years of experience at a biotech company in this role. CPA or MBA required.

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DIRECTOR/SR. DIRECTOR CLINICAL GCP QUALITY

Location: Tokyo, Japan

The Director/Sr. Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the clinical development programs, from start-up through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy and quality management systems and interact directly with the clinical, regulatory and quality teams. The ideal candidate will have 15+ years of experience in clinical quality and process improvement. The candidate will have an excellent working knowledge of Good Clinical Practices, and quality requirements and regulations in Japan and other Asia Pacific countries, such as Korea and Taiwan. In addition, knowledge of other international regulations (e.g. US FDA, EU) and Good Clinical Practices are desirable.

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LABORATORY ASSISTANT/RECEIVING CLERK

Location: San Diego, CA

The Laboratory Assistant/Receiving Clerk is an entry level position but one that is fundamental in supporting all research at Aspyrian. The Laboratory Assistant will support the research labs by making solutions and stock reagents, stocking, taking inventory and maintaining the tissue culture labs. The Laboratory Assistant also ensures the maintenance of laboratory equipment, escorting vendors, and working with onsite trades. The duties of the Receiving Clerk evolve around daily package deliveries. Once all deliveries are checked in, the Receiving Clerk reviews the items for damage, checks the PO for consistency and delivers the package to the end user. This role is fundamental in the smooth daily operations of the entire facility.

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SENIOR STATISTICAL PROGRAMMER

Location: San Diego, CA or San Mateo, CA

The Senior Statistical Programmer is responsible for providing timely support to clinical study teams on all programming matters (simple to complex) related to processing data from clinical studies. You will play a key role in developing, implementing, and evaluating statistical programming standards and processes. This role will function as the lead programmer on assigned studies, phase I to IV. 

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SENIOR ACCOUNTANT

Location: San Diego, CA 

The Senior Accountant will be responsible for balance sheet account reconciliations, international subsidiary accounting, clinical trial accruals, and other accounting functions. Ideal candidates will have at least 2 years of public accounting experience and a CPA license.         

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SENIOR SPECIALIST- ANALYTICAL FORMULATION DEVELOPMENT

Location: San Diego, CA 

The Sr. Specialist is a key member of the Analytical Formulation Development team and is responsible for supporting Aspyrian’s late-stage clinical program of a first-in-class photoactivatable monoclonal antibody conjugate. The ideal candidate will have shown proficiency in advanced analytical characterization techniques for antibody-drug conjugates and the ability to collaborate with CROs and other third party testing organizations. Responsibilities include method development and validation, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation and development stability studies.

     

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SENIOR ASSOCIATE I/II- ANALYTICAL FORMULATION DEVELOPMENT 

Location: San Diego, CA 

The Sr. Associate I/II is a key member of the Analytical Formulation Development team and will be involved in supporting Aspyrian’s research and discovery programs and CMC activities. The candidate will perform HPLC, CE, ELISA and LC-MS based methods for structural characterization of Aspyrian’s first-in-class photoactivatable monoclonal antibody conjugates. The ideal candidate will have shown proficiency in hands-on analytical work and the ability to collaborate with third party testing organizations. Responsibilities include method development, routine testing, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation, and development stability studies.         

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