CLINICAL TRIAL MANAGER

Aspyrian Therapeutics is looking for a Clinical Trial Manager who 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. 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. Please note that this job will require travel up to 50% US and ex-US, depending on trial activities.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 0001-LF


REGULATORY AFFAIRS HEAD, ONCOLOGY

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

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at jobs@aspyriantherapeutics.com; reference job code: 15MGG


DIRECTOR, QUALITY ASSURANCE

Aspyrian Therapeutics is seeking a Director of Quality Assurance, who will be a key member of the Technical Operations team with responsibility for establishing and administering all Quality functions related to cGMP operations at Aspyrian and Aspyrian’s Contract Manufacturing Organizations (CMOs). The Director will provide quality oversight and support of Aspyrian’s manufacturing, testing and product distribution functions (internal and external). The position requires domestic and international travel primarily to CMO locations to conduct audits, serve as person-in-plant for critical operations or as manufacturing designee, and to ensure compliance with cGMPs. The candidate must have a BA, MS or PhD with at least 10 years experience in a quality assurance or related role. Specific experience in biologics-based products required, and experience with antibody-drug conjugates or devices desirable. 

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 016-MGG

 

 


DIRECTOR OF BIOSTATISTICS

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0019-MB


ACCOUNTING MANAGER

Aspyrian Therapeutics is seeking an Accounting Manager to oversee the month-end close process, preparing/reviewing journal entries to be entered in the general ledger, and assisting with the monthly financial reporting to ensure a timely and accurate month-end close.  The Accounting Manager should have experience processing transactions and entering journal entries using Great Plains and full cycle accounting knowledge including audit and SOX compliance.  The candidate must have a Bachelor's degree in Accounting, CPA preferred.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0020-AM


CLINICAL QUALITY MANAGER

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0021-MB


MEDICAL WRITER

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0022-MB


DIRECTOR/SR. DIRECTOR CLINICAL GCP QUALITY

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0023-MB


ASSOCIATE DIRECTOR GLOBAL CLINICAL SUPPLIES

Aspyrian Therapeutics is seeking an Associate Director Global Clinical Supplies for managing both investigational drug and device for both U.S. and global clinical trials, in coordination with the clinical, CMC, regulatory, quality, and finance teams.  The Associate Director Global Clinical Supplies will work with CMC and Clinical to monitor and communicate regarding investigational drug/device expiry/retest and work with clinical to ensure provision or appropriate expiry/retest documentation. The Associate Director Global Clinical Supplies will also have an excellent understanding of the drug development process and be able to independently forecast and manage supply needs and distribution during clinical study conduct. The candidate must have a Bachelor's degree or Master's degree in life sciences or related field.  The candidate must also have a minimum of 10 years experience in clinical supply chain management, with global experience preferred.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0023-MB


VP, CLINICAL DEVELOPMENT

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0029-MB


PROJECT MANAGER, DRUG DEVELOPMENT

Aspyrian Therapeutics is seeking a Project Manager to collaborate closely with development functions, including the clinical team, CMC manufacturing, regulatory, device manufacturing and other functions, to ensure cross-functional coordination is achieved to meet timelines in a resource and budget effective manner.  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 10 years experience in drug development project management with 5 years of experience with managing projects in industry setting.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0027-ES


PROJECT MANAGER, TRANSLATIONAL R&D

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.

For more information about this job opportunity please see the full job description attached here.

Please submit your resume and statement of interest for this position to Aspyrian Human Resources at

jobs@aspyriantherapeutics.com; reference job code: 0026-ES