At Asymchem Clinical (Clin-nov), our people are valued as our most precious asset. We welcome a diverse team of professionals who are inspired to be competitive in an ever-changing environment. The most important thing we do is to help our clients deliver life-changing therapies to patients who need them quickly.
If you are interesting in joining our team please email your CV/résumé to HR-Hiring@clin-nov.com (Please use “Working location - Position - Education Background – Name” as the subject line of your email)
View open positions here
Job Responsibility Summary：
>> Responsible for the management and performance of clinical studies from sponsors. In accordance with
the ICH-GCP and other relevant laws, regulations and technical guidelines and company SOPs for the
conduct of the project from feasibility, startup, monitoring, and close out etc. Ensure that the project is
performed under timeline, budget and in high quality standard.
>> Participate in business development technical support related work.
Job Responsibilities：
>> Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management
of trial timeline, budget, resources and vendors.
>> Provide efficient updates on trial progress to Heads of Project Management and Clinical Operation (CO)
US, with respect to vendor selection, project plans, trial budget and timeline management, quality
standards, risk mitigation and all other project health indicators.
>> Ensure effective study plans are in place and operational for each assigned trial and work proactively with
the Clinical Team in accordance with applicable project plans, company SOPs, ICH/GCP guidelines and
regulatory requirements as applicable.
>> Ensure potential study risks are escalated to the attention of the Heads of Project Management and CO
US when appropriate.
>> Chair Clinical Team meeting and vendor status update meetings and ensure meeting minutes are
completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
>> Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and
identify opportunities to improve training, execution and quality control across the clinical team.
>> Review and approve vendor and site invoices in collaboration with the accounting team to ensure related
payments occur in a timely manner.
>> Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and
accordance with company SOPs and regulatory requirements.
>> Support business development by participating in capabilities presentations, bid defenses and networking
events.
>> Act as opportunity leader for responses to RFP and contribute to proposal text and budget.
Job Requirements：
1、Education/Experience：
>> Bachelor or advanced degree in Life Sciences.
>> Eight or more years of project management and clinical operations combined experience; with increasing
levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is
required.
>> Experience in early phase trials as a plus.
>> Ability to travel up to 20%
2、Skills：
>> Ability to establish and maintain effective working relationships with coworkers, managers and
clients.
>> Ability to coordinate the effort of multiple contributors towards a common goal.
>> Ability to demonstrate strategic thinking.
>> Strong communication, presentation, and interpersonal skills.
>> Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive
landscape in applicable therapeutic area.
>> Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
Contact Us：Email（zhaoruijia@clin-nov.com）
Job Responsibilities:
>> Responsible for INTERACT (for CGT), Pre-IND, IND, EOP1, EOP2, BTD, Fast Track, ODD, NDA/BLA submissions of small molecule, biologics, and CGT product to FDA
>> Write CMC and non-clinical summary documents for FDA submission.
>> Responsible for China and US Regulatory Affairs strategy
>> Manage interactions with regulatory agencies, including FDA and other international regulatory bodies.
>> Provide regulatory guidance to cross-functional teams, including R&D, medical and BD.
>> Stay current with regulatory developments and updates and communicate changes to internal stakeholders.
>> Develop and maintain regulatory procedures and processes to ensure ongoing compliance.
Job Qualifications:
>> Master's degree in a scientific discipline required; advanced degree preferred.
>> 8+ years of experience in regulatory affairs in Biotech/Pharma
>> Deep understanding of non-clinical, CMC and clinical data and relevant guidance requirements including but not limited to ICH, FDA technic guidance.
>> Strong understanding of pre-market regulatory requirements of US FDA.
>> Proven track record of successfully navigating the regulatory process for product approvals.
>> Strong negotiating skills and ability to think creatively and develop creative solutions.
>> Excellent communication, leadership, and project management skills.
>> Ability to work independently and as part of a team in a fast-paced environment.
>> China or EU regulatory affairs experience is a plus.
>> Job Type: Full-time
Contact Us：Email（zhaoruijia@clin-nov.com）
Job Responsibility Summary：
Provide medical expertise in setting project development strategy and clinical study design in collaboration with internal cross functional teams and the client’s team; provide medical support to clinical study teams from protocol development and medical feasibility, to safety monitoring and study reporting.
Job Responsibilities：
>> Serve as Global and /or Regional Medical Expert on assigned projects.
>> Serve as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
>> Provide medical support to investigative sites and study staffs for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
>> Perform medical input and/or review of the protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF) and/or Case Report Forms (CRFs).
>> Be responsible for protocol development in partnership with other functions as appropriate.
>> Provide therapeutic area/indication training for the project team.
>> Attend and present at Investigator Meetings.
>> May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
>> Oversight and review of escalated issues/gaps and proposals for process improvement and initiatives.
>> Perform input and/or review of the Clinical Study Report (CSR) and patient narratives.
>> Attend Kick-Off meetings, team meetings, and client meetings, as needed or requested.
>> Provide expert advises to the development of delivery strategies for studies in partnership with other functions responsible for business development activities.
>> Be responsible for the development of the medically related aspects of client proposals including the budget.
>> Provide medical and scientific advice to key internal stakeholders developing proposals.
>> Attend and present at bid defense meeting, as required.
>> Participate in strategic business development activities including presentations to prospective clients.
Job Qualifications：
1、Education Background:
>> Medical degree from an accredited and internationally recognized medical school.
2、Working Experience：
>> Years of experience in the job discipline: minimum 10 years, postgraduate training can be substituted by relevant expertise.
>> Minimum 5 years' experience in clinical medicine.
>> Minimum 3 years’ clinical trials experience as an investigator or medical /clinical expert in the Pharma, CRO, or Biotech industry.
3、Skills：
>> Ability to establish and maintain effective working relationships with coworkers, managers and clients.
>> Strong communication, presentation and interpersonal skills.
>> Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
>> Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
4、Others:
>> Current and valid country/state medical license; Specialty Board certification in relevant specialty area preferred.
Contact Us：Email（zhaoruijia@clin-nov.com）
Linkedin:
HR Wechat: 
Department：
Location：
HR Wechat
