Careers

Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

JOB SUMMARY:
The Head of Toxicology will be part of the Preclinical Development group supporting small molecule drug development at Asieris and will provide scientific expertise and leadership to the safety assessment of all Asieris programs. The candidate is expected to work in a highly collaborative team environment, playing a pivotal role at each stage of preclinical and early clinical development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide expert support, guidance and strategy on project safety assessments, with a specific focus on discovery & IND-stage small molecule projects.
• Serve as the key resource for toxicology, providing scientific knowledge and expertise to cross-functional project teams.
• Develop overall toxicology strategy and plans for lead candidates based on clinical development plan.
• Oversee preclinical toxicology studies at multiple external Contract Research Organizations (CRO).
• Design & execute investigative toxicology studies, based upon off & on-target safety profiles of the candidate drugs.
• Initiate appropriate processes for contract implementation, protocol development, and timeline optimization for toxicology studies.
• Monitor toxicology studies for appropriate conduct, accuracy and timely execution; audit raw data for accuracy, review draft reports and finalize them as submission-ready documents for regulatory authorities.
• Proactively respond to study issues and resolve problems with study director.
• Internal and external communication
• Prepare verbal and written summaries for internal discussions. Work with the Preclinical Development team to develop optimal strategies to address specific safety issues and partner with project teams.
• Review and/or author toxicology and/or safety pharmacology sections of various regulatory documents (e.g., pre-IND briefing documents, INDs, IBs etc.) and ensure their regulatory compliance.
• Represent company at meetings with regulatory agencies.
• Present summary data to project teams and Asieris senior leadership.

EDUCATION AND EXPERIENCE:
Ph.D. in Toxicology, Pathology, Physiology, Biochemistry or expertise in related biological science disciplines, with an emphasis on Oncology/Immunology is preferred. Ph.D.; Board Certification in Veterinary Anatomic Pathology (ACVP) and Board Certification in Toxicology (DABT) is highly desired.

REQUIREMENTS:
• 10+ years’ experience in toxicology small molecule drug development in Biotech/Pharma industry.
• Experience in filing multiple INDs is a must; experience in filing NDAs will be a plus.
• An in-depth understanding of toxicology and/or toxicologic pathology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
• Experience in supporting project team as toxicology representative.
• Excellent oral/written communication skills in English and Chinese.
• Additional expertise in specific toxicology areas, e.g. developmental & reproductive systems toxicology, endocrine systems toxicology, Toxico-kinetics/Toxico-dynamics simulation analyses etc., is a strong plus.

COMPENSATION & BENEFITS:
As a full-time employee of the Company, you will be eligible for company benefits：
• Flexible Working hours
• Paid Vacation
• 401k Plan
• Medical Insurance
• Year-end Performance Bonus
• Long Term Incentive Plans

Interested candidates please feel free to contact:

Human Resources – Ms. Cao Email: lxcao@asieris.cn

Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. To know us more, please visit: https://www.asieris.cn

(Associate) Project Director, Project Management

Job Description:
• Provides operational expertise and leadership to one or more cross-functional global study management teams
• Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases and stages, in accordance with the appropriate quality standards.
• Ensures overall project meets delivery requirements by collaborating with team members of differential functional groups in a matrix structure.
• Responsible for leading identification and selection of vendors
• Ensures appropriate cross-functional input into the scope of work
• Ensures the projects being executed on time, within budget and high quality
• Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics
• Maintains a positive and results orientated work environment
• Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
• Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged for future work
• Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in vendor governance
• Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across Asieris
• Ensures Clinical Operations thinking, and activities are aligned with overall business direction and priorities
• Recommends best practices within Clinical Operations that if more broadly applied would benefit Asieris as a whole
• Maintains a working knowledge of, and assures compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs
• Contributes in SOP/Process/system improvement
• Communicates with internal and external staff effectively with a professional and collaborative approach.
• Escalates issues to Asieris Senior Management team timely.
• Performs any other reasonable tasks as required by the role.
• Serves as a Line manager to project managers when necessary, and mentors the junior project managers, drives team members to improve their efficiency and effectiveness at prioritizing work and improving performance
• Leads program managements when needed, to drive efficiency, alignment and planning among the projects.

Qualification Required:
• Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology)
• 10 years or above in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
• Minimum of 4 years experience of project managing operational aspects of a clinical study including development and management of timelines and budgets (Associate Director).
• Minimum of 6 years of project management experience (Director)
• Experience of line management is preferred (Director).
• Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
• Fluent in written and verbal English

Interested candidates please feel free to send your CV to Ms. Tracy Yu, Asieris Human
Resources: jmyu@asieris.cn

Clinical Pharmacologist (Senior Manager – Associate Director, depending on qualification)

• Full-time
• Reporting to Head of Clinical Pharmacology
• Location: US (Remote) or China (Shanghai or Beijing)
• A competitive total compensation and benefits package and internal growth opportunities

GENERAL POSITION SUMMARY:

A Clinical Pharmacologist will design, conduct, analyze, and report on clinical pharmacology studies and be responsible for providing clinical pharmacology components of protocols, clinical development plans, and regulatory documents.  He/She will work closely in collaborative manner with cross-functional teams.  He/She will complete assigned work in a resourceful and self-sufficient manner and have the ability to effectively communicate through verbal and written communication.  The candidate will have a good knowledge of related disciplines which interact with the Clinical Pharmacology activities.  We emphasize on the candidate’s quantitative pharmacology skills, scientific reasoning, regulatory affairs skills, written and verbal communication skills, study design and report writing skills.

KEY RESPONSIBILITIES:

• Prepare clinical pharmacology summary documents (CTD module sections 2.5 and 2.7) for regulatory submission.

• Contribute to clinical pharmacology sections of clinical study protocols, study analysis plans, clinical study reports and clinical development plans.

• Lead clinical pharmacology studies and perform PK (e.g., NCA analysis) and PK/PD analyses.

• Prepare standalone PK/PD reports or PK/PD section of Clinical Study Report (CSR).

• Collaborate and/or co-direct modeling plans or build on prior analyses to guide and/or assist with PK/PD modeling and simulations.

• Serve as clinical pharmacology lead in cross-functional study team settings, providing oversight of protocol conduct and internal decision points, data analyses, presentation of PK findings, and final PK and PK/PD report writing regarding pharmacology components of clinical studies.

• Collaborate with biostatistician, clinical operation, bioanalytical scientist and clinician for the execution and management of Phase I-III studies.

• Provide human dose recommendation for FIH and PoC studies based on quantitative translation of preclinical and clinical Phase I PK and PK/PD data. 

• Assist in contract research organization management regarding clinical pharmacology studies.

• Maintain a high standard for good clinical practice, compliance and ethics.

QUALIFICATIONS:

• Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist or pharmacometrician within biotech/ pharmaceutical industry.

• Preparation of clinical pharmacology summary documents (CTD module sections 2.5 and 2.7) for regulatory submission.

• Non-compartmental pharmacokinetic (PK) and PK/PD analyses.

• Understanding of PK, PK/PD and drug metabolism, and ability to apply PK and PK/PD concepts, including modeling and simulation to clinical trial design.

• Ability to translate PK findings into potential clinical impact.

• Strong technical proficiency in pharmacokinetic software (e.g., WinNonlin, Phoenix NLME, etc.).

• Skills with commercial PBPK software is preferred, but not required.

• Communicate clearly in verbal and written communications in both English and Chinese.

COMPANY INFORMATION:

Asieris Pharmaceuticals (688176.SH), founded in March 2010 and headquartered in Shanghai, China, is a global innovative clinical stage pharma company specializing in discovering new drugs for the treatment of genitourinary tumors and other major diseases.  We aim to become a leading global specialty pharma that integrates R&D, manufacturing and commercialization in genitourinary diseases. Two core products, Vesique® (APL-1202) and Cevira® (APL-1702), targeting at addressing the global unmet needs for the treatment of bladder cancer and cervical precancerous lesions, respectively, are currently in Phase III/pivotal clinical development. Asieris was named as one of the Top 30 Chinese Innovative Enterprises in Small Molecule Drugs in October 2021 at a conference organized by MENET.

Interested candidates please feel free to send your CV to Ms. Tracy Yu, Asieris Human Resources: jmyu@asieris.cn

COMPANY MISSION: 

Asieris Pharmaceuticals is a global clinical stage pharmaceutical company specializing in discovering new drugs for the treatment of genitourinary cancer and other major diseases, headquartered in Shanghai, China. It was selected to be among the top 30 innovative small molecule drug discovery companies in China in October 2021.

JOB SUMMARY:

We are currently building a new Discovery Biology team located in the San Francisco bay area in USA. We are seeking outstanding Research Associate or Senior Research Associates to join our new research team. The US team will focus on innovative research that will lead to discovery of new drug targets in Asieris’ niche indications and the development of drug compounds. We will also explore biologics modality in addition to small molecule drug modality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Help set up lab functionality and operation

• Execute in vitro assays to study mechanism of action of drugs; Immunology and oncology assays will be our initial focus

• Design, trouble-shoot, validate, and implement biochemical and cell-based assays to support drug discovery and selection 

• Conduct ex vivo pharmacodynamic marker or biomarker discovery work as needed

• Interpret, record, and present complex biological data 

• Communicate effectively and collaborate with colleagues

REQUIREMENTS:

• BS or MS degree in biological sciences with at least one year of lab experience

• Demonstrated proficiency with cell and biochemical assays, molecular biology, and mammalian cell culture techniques

• Experience with primary immune cell functional assay and flow cytometry is a big plus

• Industry experience with ranking compounds in assays is a plus

• Strong analytical and troubleshooting skills

• Independent and self-motivated

• Team oriented and dependable

Please contact achen@asieris.cn if interested

COMPANY MISSION:

Asieris Pharmaceuticals is a global clinical stage pharmaceutical company specializing in discovering new drugs for the treatment of genitourinary cancer and other major diseases, headquartered in Shanghai, China. It was selected to be among the top 30 innovative small molecule drug discovery companies in China in October 2021.

JOB TITLE: Scientist / Senior Scientist
DEPARTMENT: Discovery Biology
REPORTS TO: Director of Biology

JOB SUMMARY:

We are currently building a new Discovery Biology team located in the San Francisco bay area in USA. We are seeking outstanding Scientists or Senior Scientists to join our new research team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Help set up lab functionality and operation;

• Design, development, and execution of novel in vitro and ex vivo assays, delivering results to facilitate new target validation, target MOA studies, and/or lead compound selection;

• Research on targets and propose new projects / new directions;

• Biomarker discovery and validation work as needed;

• Set up lab SOP and train/manage junior employees as needed.

REQUIREMENTS:

• Ph.D. degree in biological sciences with 2-5 years of postdoc or drug discovery experience, preferably in immunology or immuno-oncology;

• Exceptional laboratory skills, with demonstrated proficiency in primary cell-based assays;

• Proven track record via high quality publications;

• Innovative thinker and problem solver;

• Strong organizational skills, communication skills and the ability to work independently and collaboratively in a fast-paced team environment.

Interested candidates please feel free to contact:

Chris Li
Email: chrisli@asieris.com