REGULATORY AFFAIRS HEAD, ONCOLOGY

Location: San Mateo or San Diego, CA 

Aspyrian Therapeutics 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 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 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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DIRECTOR OF BIOSTATISTICS

Location: San Mateo or San Diego, CA 

Aspyrian Therapeutics is seeking a Director of Biostatistics to oversee all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports, and regulatory submissions.  The Director of Biostatistics will provide strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions, and follow-up. The Director of Biostatistics will also provide overall statistical leadership, direction, and consulting as it relates to the design, analysis, and reporting of clinical trials in support of all Phases of clinical development and regulatory submission programs. The candidate should have a PhD in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience.

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CLINICAL QUALITY MANAGER

Location: San Diego, CA

Aspyrian Therapeutics 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

Aspyrian Therapeutics 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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DIRECTOR/SR. DIRECTOR CLINICAL GCP QUALITY

Location: San Diego, CA

Aspyrian Therapeutics is seeking a Director/Sr. Director of Clinical GCP Quality to be responsible for evaluating and mitigating risk of the clinical development programs, from start-up through completion of clinical trials.  The Director/Sr. Director of Clinical GCP Quality will advise on company clinical quality strategy and quality management systems and interact directly with the clinical, regulatory, and quality teams. The Director/Sr. Director Clinical GCP Quality will also provide strategic and operational leadership in the planning and executing of Clinical GCP Quality activities to support companywide and clinical development/clinical trial Quality activities. The candidate must have a Bachelor's degree in life sciences with advanced degree in a scientific discipline preferred.  The candidate must also have a minimum of 15 years experience in clinical quality and process improvement.

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VICE PRESIDENT, CLINICAL DEVELOPMENT

Location: San Mateo, CA

Aspyrian Therapeutics is seeking a VP of Clinical Development to be a key leader supporting strategy and operational implementation of clinical activities to support development of 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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PROJECT MANAGER, TRANSLATIONAL R&D

Location: San Diego, CA

Aspyrian Therapeutics is seeking a Project Manager to be responsible for coordinating the planning and execution of the translational R&D, contracted pre-clinical studies, CMC, devices, clinical, and regulatory activities from program conception to IND filing. The Project Manager will coordinate meetings, follow-up with meeting minutes and actions, identify gaps, track execution, forecast potential delays, integrate budgets, and find actionable solutions to challenges. The Project Manager will also be responsible for reviewing statements of work, master service agreements, and quality agreements. The candidate must have a Bachelor's degree or Master's degree, PhD preferred.  The candidate must also have a minimum of 5 years in research and development industry with at least 2 years of experience with managing projects in industry setting.

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SENIOR ASSOCIATE SCIENTIST, IN VIVO PHARMACOLOGY

Location: San Diego, CA

Aspyrian Therapeutics is seeking a Senior Associate Scientist to be the the primary lead for the company's preclinical in vivo pharmacology research program. This person will contribute to the multidisciplinary research team by designing and executing in vivo studies determining the efficacy of novel anticancer therapeutics. This individual will be expected to participate and present data at weekly research meetings, as well as support the research team by providing tissue samples required for ex vivo analysis. As the technical lead, he or she will also train all other members of the multidisciplinary research team in the scientific and operational aspects of the program. 

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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 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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LEGAL COUNSEL - CONTRACTS & ALLIANCE MANAGER

Location: San Mateo, CA 

The Legal Counsel will manage the preparation and review of legal contracts and alliance documents for Aspyrian’s external partners and contractors such as general suppliers, contract research/clinical/manufacturing organizations, etc. He or she will provide legal support to a broad range of Aspyrian’s functions including R&D, Clinical and Medical Affairs, CMC, Corporate Development, Marketing and Commercial Operations. The Legal Counsel will write and/or review legal sections of documents related with Aspyrian partnering activities, including academic organizations such as national and international Universities and the USA National Institute of Health. They will also coordinate external legal support to manage other company activities such as corporate law and intellectual property.

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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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HEAD OF MEDICAL AFFAIRS

Location: San Mateo, CA 

The Head of Medical Affairs will be responsible for building a Medical Affairs department in a growing organization, leading medical strategy and execution, launch preparations and all aspects of Aspyrian's pipeline. This individual will report to the CEO and work closely with our global clinical team, R&D, commercial/sales, regulatory and other teams to prepare for the launch of our lead products. This leader will be responsible for providing medical insight, guidance, strategy, compliance and training internally and externally, among other leadership roles. The Head of Medical Affairs will provide critical medical practice insights to drive the late stage clinical development, HEOR, publications, marketing, market access, interaction with patient organizations and other stakeholders to ensure alignment of US and global medical strategies. The ideal candidate will have an advanced degree in life sciences and at least 15 years of relevant academic, industry, and clinical experience with minimum 10 years in Medical Affairs and 3 years in an executive position.

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CLINICAL TRIAL MANAGER 

Location: San Diego or San Mateo, 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. The ideal candidate will have 7+ years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.

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SENIOR CLINICAL DATA MANAGER

Location: San Diego, CA 

Aspyrian Therapeutics 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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FIELD CLINICAL TRAINERS -  USA 

Aspyrian is looking for Field Clinical Trainers across the USA. They will be key members of the Clinical Operations team with responsibilities to train physicians and support staff to properly perform Aspyrian drug product infusions and photoimmunotherapy procedures.  The Field Clinical Trainer will also provide feedback to clinical and R&D regarding product performance and may train site personnel with study-related data collection and/or documentation practices. The ideal candidate will have a RN, PA, NP or other relevant clinical license with experience in surgical, interventional radiology, intensive care or radiation oncology settings, and will have prior experience in an educator or trainer capacity.  Additionally, a working knowledge of drug development process, GCP, ICH guidelines and FDA regulations is highly desirable. This position will require the ability and willingness to travel extensively up to 70% time, within the U.S. and Canada.

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