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


ACCOUNTS PAYABLE SPECIALIST

Aspyrian Therapeutics is looking for an Accounts Payable Specialist to process the day to day accounts payable transactions to ensure that company finances are maintained in an effective and accurate manner. This individual must be reliable, detail oriented, possess strong work ethics and be able to effectively interact with employees, vendors and customers. The ideal candidate will have a B. S. of relevant education plus minimum 2 years of experience in accounts payable.

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-SS


DATA MANAGEMENT, DIRECTOR

Aspyrian Therapeutics is looking for a Director of Data Management who will be primarily responsible for ensuring that clinical trial databases are designed, built, validated, and function properly to record, process, and report complete, accurate, timely data. The Director of Data Management will also be responsible for preparing reports and summaries and compiling data from study databases on a regular basis for trial oversight and management purposes. The ideal candidate will have a B. S. or M. S. of relevant education plus minimum 10+ years of experience in clinical data management.

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: 0002-LF


RESEARCH ASSOCIATE, PHARMACOLOGY

Aspyrian Therapeutics is looking for a Research Associate who will be responsible for supporting Aspyrian’s preclinical oncology research program in multiple ways. In this role, the Research Associate will broadly contribute to the multidisciplinary research team by executing a variety of assays involving in vitro cell biology, immunoassays, and ex vivo tissue processing and staining. Furthermore, the Research Associate will maintain and upscale cell lines for allografts and xenografts as needed. The ideal candidate will have a B. S. or M. S. plus minimum 2+ years of experience in an academic or industry laboratory 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: 0001-JF


RESEARCH ASSOCIATE/SRA, CONJUGATION/TECHNICAL OPERATIONS/CMC

Aspyrian Therapeutics is looking for a key member of the Technical Operations team and will be involved in supporting Aspyrian's research and discovery programs and CMC activities. The candidate will be pivotal for developing conjugation processes in support of Aspyrian's first-in-class photoactivatable monoclonal and antibody conjugates. In addition, the candidate will be responsible for internal material supply to support the development, research and discovery programs. Other responsibilities include support of tech transfer, development programs, and manufacturing activities at Aspyrian's contract manufacturers, including person-in-plant (PIP) activities. The ideal candidate will have 5+ years of experience in the Biotech/Pharmaceutical industry and a BS or BA OR 3+ years of relevant experience and a MS.

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-CG


HEAD OF TECHNICAL OPERATIONS AND CMC

Aspyrian Therapeutics is looking for a Head of Technical Operations and CMC who will be a key leader of our management team and will coordinate the strategic direction and operational responsibilities of the CMC team with key responsibilities related to manufacturing processes of clinical and commercial products for worldwide distribution. The Head of Technical Operations and CMC will work very closely with other functions of the company, including Regulatory Affairs, Quality Assurance, Clinical, Supply Chain, etc. The Head of Technical Operations and CMC will also play the leading role in management, recruiting and building the Technical Operations team. The candidate should have at least 15 years related industry experience in CMC operations and a minimum of 5 years in CMC of biologics.

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: 16MGG


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


RESEARCH ASSOCIATE/SENIOR RESEARCH ASSOCIATE, ANALYTICAL CHARACTERIZATION

Aspyrian Therapeutics is looking for a RA/SRA who will be a key member of the Analytical Characterization team and is responsible for supporting Aspyrian's internal laboratory-based analytical characterization capabilities. The candidate should have a B.S. or equivalent in life sciences with at least 2-5 years related industry experience including: HPLC (SEC, IEX, RP), mass spectrometry (intact mass and peptide mapping), and capillary electrophoresis.  

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: 0002AM


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: 11RD