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Are you the next “Asieris-er “on our team? Consider a career with Asieris Pharmaceutical (USA) Inc. let’s realize your potential together.
Who You Are
We are seeking applicants with the following attributes. The level of the position will depend on the qualifications of the selected candidate.
Description
We are seeking a highly motivated and experienced leader as the Head of Global Clinical Development (HGCD) based in China or the US. You will report to the Chief Development Officer (CDO) and work closely with the Leadership Team to define clinical and medical strategy, accountable for clinical projects. Responsible to build and strategize the investigational product development for one or more IPs, and steer with the responsible team members within the medical and clinical department, and cross-functional matrix, including Clinical Operation and CRO(s), responsible/guide for evaluation of emerging clinical trial data, data interpretation and data mining; ensure the conduct of studies according to GCPs and Departmental SOPs; oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries; and lead the preparation of IND, NDA/BLA filing packages.
- Function as the medical and clinical lead for pre-registrational new drug development activities by evaluating new product potential and providing strategic recommendations with medical expertise.
- Lead and strategize the generation and implementation of clinical development plans, including TPP, study design, etc. for one or more IPs.
- Supported by medical monitor function and other medical functional roles, guiding and organizing the team members for the planning, implementation, managing, and reporting of clinical trials and programs. Prepare, review, and approve clinical trial synopses and protocols, IB, and CSR. Review and approve Medical Monitoring Plans, Safety Plans, and Protocol Deviation Plans. Review SAPs and tables, LTF shells.
- Oversee/Guide data interpretation and data mining. Ensure that assigned studies are conducted according to GCPs and organizational SOPs Guide in conducting literature searches/reviews, meta-analyses, and publishing data Contribute to the preparation of IND/NDA medical sections.
- Work closely with the internal team including clinical operation and CRO in the execution of trials and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies.
- Meet and aim to exceed project expectations by recruiting, retaining, and developing a skilled, experienced, and motivated medical team. Manage and oversee appropriate resourcing of staff and staff assignments. Coach and provide guidance to the staff to be compliant.
- Keep abreast with scientific knowledge of oncology drug clinical development and handles other tasks as required by Supervisor.
Requirements.
- Major in clinical medicine, with physician experience in clinical practice, in urology or gynecology would be a plus.
- The incumbent should have at least 10 + years of directly related pharmaceutical clinical research experience in both early and late phase studies, and MNC working experience is a plus.
- Experience in a leadership role within a matrixed, multifunctional R&D organization.
- Demonstrated ability in strategic thinking and contingency planning with respect to pharmaceutical objectives
- Track record of exposure to the IND/NDA/BLA application and approval process.
- The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information.
- Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance. Demonstrates the ability to work independently, analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential. Experience in people management, and matrix structure.
- Strong oral and written communication skills
- Good planning and tracking skills
- Demonstrated influence, negotiation, and conflict resolution skills, including the ability to influence without clear reporting authority.
- Good problem-solving skills for developing creative solutions.
- Job-related travel (domestic or international) is expected (max. 20%).
This position provides a unique opportunity to join and contribute to a fast-paced team, with a cutting-edge technology platform, and ample opportunity to grow with the company.
Benefits at a Glance:
Asieris provides the following competitive benefits:
- Medical, Dental, Vision
- Competitive Salary
- Company Paid time off, Sick leave, federal Holidays, Floating holidays.
- Retirement savings plan – 401(K) plan/employer Match
If you have the drive, passion, and experience and are excited by this opportunity, and are ready to take your career to the next level then Apply Today!
Are you the next “Asieris-er “on our team? Consider a career with Asieris Pharmaceutical (USA) Inc. let’s realize your potential together.
Who You Are
We are seeking applicants with the following attributes. The level of the position will depend on the qualifications of the selected candidate.
Description
We are seeking a Regulatory Affairs Senior/Executive Director who will be responsible for the development and delivery of solution-oriented regulatory strategies and will oversee all aspects of regulatory document preparation and submissions. This role will manage Regulatory team members and collaborate with cross-functional teams such as CMC, Medical, Clinical Operations, & Business Development etc.
- Provide strategies for pipeline development in terms of Regulatory Affairs
- Manage the content of regulatory dossiers
- Oversee and be accountable for regulatory communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals.
- Resolve conflicts in regulatory strategies and oversee critical deliverables.
- Represent the company at key regulatory-related meetings; to moderate and lead discussions.
- Develop and maintain effective relationships with regulatory officials, regulatory experts, and consultants to optimize regulatory outcomes.
- Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory procedures, changes, and trends
- Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions.
- Lead and develop a team of RA professionals.
Requirements
- Master degree in life science disciplines
- Minimum of 15 years of industry experience
- 10+ years of direct regulatory affairs experience in the conduct of CFDA/FDA/EMA-regulated clinical trials, oncology experience preferred;
- Extensive experience with CFDA/FDA/EMA regulatory processes, documents, and requirements, such as INDs, clinical trial applications, meeting request procedures, and materials
- 8+ years of management experience
- Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations
- Good problem-solving skills for developing creative solutions.
- Excellent verbal, and written communication and meeting presentation skills in both Chinese & English
- Job-related travel (domestic or international) is expected (max. 20%).
Benefits at a Glance
Asieris provides the following competitive benefits:
- Medical, Dental, Vision
- Competitive Salary
- Company Paid time off, Sick leave, federal Holidays, Floating holidays.
- Retirement savings plan – 401(K)
If you have the drive, passion, and experience and are excited by this opportunity, and are ready to take your career to the next level then Apply Today!
About Us
Asieris Pharmaceuticals (688176. SH) founded in March 2010, is a China-based biotech company with a global aspiration to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and other major diseases. Our mission is to improve human health for a more dignified life. We aim to become a global leader in our areas of focus by providing our patients with the best solutions, from disease diagnosis to treatment.
Asieris is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Are you the next “Asieris-er “on our team? Consider a career with Asieris Pharmaceutical (USA) Inc. let’s realize your potential together.
Who You Are
We are seeking applicants with the following attributes. The level of the position will depend on the qualifications of the selected candidate.
Description
We are currently building a new Discovery Biology team located in the San Francisco Bay area in USA. We are seeking outstanding Research associates or Senior Research associates to join our new research team. The US team will focus on innovative research for the discovery of new drug targets and the development of therapeutics in Asieris’ niche indications.
- 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, troubleshoot, 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
This position provides a unique opportunity to join and contribute to a fast-paced team, with a cutting-edge technology platform, and ample opportunity to grow with the company.
Benefits at a Glance
Asieris provides the following competitive benefits:
- Provides Medical, Dental, Vision
- Competitive Salary
- Company Paid time off, Sick leave, federal Holidays, Floating holidays.
- Retirement savings plan – 401(K) plan/employer contribution
If you have the drive, passion, and experience and are excited by this opportunity, and ready to take your career to the next level then Apply Today!
About Us
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.
Asieris is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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 & 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 & 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
Are you the next “Asieris-er “in our team? Consider a career with Asieris Pharmaceutical (USA)
Inc. let’s realize your potential together.
Who You Are?
We are seeking an experienced and highly creative CO Director，Clinical Operation to manages and
develops Clinical Operation US team and participates in the planning and implementation of the
overall development strategy of Asieris clinical operations team. Who oversees and manages project
and site related activities, supervise, or develop action plans as needed to improve overall
operational efficiency，especially for US part. This CO-Director will ensure overall project meets
delivery requirements by collaborating with team members of differential functional groups. We are
seeking applicants with the following attributes. The level of the position will depend on the
qualifications of the selected candidate.
Description
• Responsible for team building, training, and management of US clinical operation team.
• Ensures the projects being executed on time, within budget and high quality，
particularly for US studies.
• Leads program managements，to drive efficiency, alignment and planning among the
projects.
• Ensures appropriate cross-functional input into the scope of work.
• Contributes to and has accountability for overall clinical operations strategy and performance
against key metrics.
• Maintains US expert, communicates with relevant review experts, clinical experts, and other
clinical research resources to develop the correct clinical implementation plan and ensures the
smooth running of clinical trials, particularly in US.
• Responsible for building up and maintaining good relationship with US sites，US KOLs,
and global vendors.
• Contributes to clinical operations and clinical trial sourcing strategy development and takes a
lead role in vendor governance.
• Contributes to SOP/process/system improvement，to ensure compliance with US FDA
and EMA requirements.
• 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.
• Escalates issues to Asieris senior management team timely.
• Complete other tasks assigned by the leader.
• May serve as Clinical Operation Head when needed.
Requirements
• Bachelor's degree or above, majoring in clinical medicine, pharmacy, biology, etc. or related
majors.
• More than 10 years of experience in clinical trials of new drugs, preferably in multinational
companies or multicultural background.
• Minimum of 5 years of project management or/and people management experience.
• Excellent communication and coordination, resource integration, planning and team management
skills, strong leadership, performance, problem solving and contingency plan management skills.
• Well familiar with the operation mode and workflow of new drug clinical trials, GCP/ICH- GCP and
other related laws and regulations, as well as the development and status of clinical research.
• Proficiency in clinical project management, familiar with the operation mode of US registered
clinical studies and international multi-center clinical studies.
• Abundant industry resources, ability to coordinate clinical resources and solve various problems
in clinical research in a timely manner.
Core competencies
• Strong attention to detail
• Teamwork and collaboration
• Achieving results
• Good problem solver.
• Good interpersonal skills
• Well organized and can manage competing priorities.
Benefits at a Glance:
Asieris provides the following competitive benefits:
• Medical, Dental, Vision
• Competitive Salary
• Company Paid time off, Sick leave, federal Holidays, Floating holidays.
• Retirement savings plan – 401(K) plan/employer Match
• Flexible schedule
• Paid time off.
If you have the drive, passion, and experience, are excited by this opportunity, and are ready to
take your career to the next level, then Apply Today!
About US
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 China's top 30 innovative small
molecule drug discovery companies in October 2021.
Asieris is committed to creating a diverse environment and is proud to be an equal-opportunity
employer. All qualified applicants will receive consideration for employment without regard to
race, color, religion, gender, gender identity or expression, sexual orientation, national origin,
genetics, disability, age, or veteran status.
