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Safety Physician

Title: Safety Physician
Company/Location: Antengene Corporation/Shanghai
Job Type: Onsite, Full-time employee
Reporting to: Chief Medical Officer

Job Purpose:
Safety Physician at the levels of Medical Manager, Medical Director, or Senior Medical Director provides safety monitoring to ongoing and upcoming oncology clinical trials in international regions and China

Essential Duties and Responsibilities:
-Serve as the Leader of the Pharmacovigilance team and report to Chief Medical Officer
-Lead safety operations to establish and maintain policies and reporting procedures for the Drug Safety
-Perform or provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, to ensure consistency of medical coding of safety data, and to ensure timely safety reports (internally or by CRO) to regulatory agencies and IRB/EC.

-Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.

-Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Teams and upper management.

-Support both Clinical Development and Clinical Operations teams with respect to safety related issues as required.

-Provide input and review of responses to regulatory agency questions with regard to safety/pharmacovigilance activities.

-Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.

-Oversee the activities of both internal and external safety meetings.

-Support development and maintenance of product benefit-risk profile.

Qualifications:
-Graduate of an accredited medical school

-Industry experience of which 3-5 years is relevant to pharmacovigilance/drug safety knowledge

-Good verbal, written and presentation skills in English and Chinese

-Good communication skills

-Knowledge of medical and drug terminology

-Knowledge of Good Clinical Practice (GCP) and ICH related to clinical safety documentation

-Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational products

-Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance

-Proactive and organized with exceptional follow-up

-Anticipate/ identify problems and takes appropriate action to correct

-High degree of accuracy with attention to details

-Willing and able to learn quickly in a fast-paced environment

-Excellent team player

Contact:
Please send your CV and cover letter to Peter.Qian@antengene.com

Regulatory Affairs Manager

Title: Manager-Regulatory Affairs
Company/Location: Antengene Corporation/Beijing
Job Type: Onsite, Full-time employee
Reporting to: Director of Clinical Operation

Job Purpose:
Lead the regulatory strategy and be responsible to prepare and supervise all relevant documents for regulatory authorities for Antengene’s phase I-III clinical studies.

Essential Duties and Responsibilities:
-Familiar with CFDA, FDA relevant regulations, standards and guidance.
-Understand the regulatory pathway of the responsible products and select the appropriate regulatory pathway
-Oversees CRO and compile registration dossier and ensure timely regulatory submission.
-Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration
-Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing
-Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, Provincial FDAs) and other key players in the regulatory environment
-Provide regulatory expertise to the R&D projects including biologics and small molecular drug products
-Continuously monitor the development of regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to clinical projects have been thoroughly evaluated and well communicated

Qualifications:
-BSc or Master’s Degree in chemistry, pharmacy or related, or MD (licensed in the country, if applicable, according to local regulations)

-Min 5 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry

-Good knowledge of written and spoken English

-Good understanding of the Chinese and global regulations

-Competent project management skills

-Ability to handle multi-task activities

-Ability to handle conflict; initiative and negotiation skills

Contact:
Please send your CV and cover letter to Peter.Qian@antengene.com

Clinical Project Manager

Title: Clinical Project Manager
Company/Location: Antengene Corporation/Beijing/Shanghai
Job Type: Onsite, Full-time employee
Reporting to: Clinical Operation Director

Job Purpose:
Responsible for project timeline and project budget, and oversees the key deliverables, project milestones for Antengene’s ongoing clinical trials

Essential Duties and Responsibilities:
-Very familiar with study protocols, CRF, ICF, lab manual, pharmacy manual, clinical monitoring plan

-Very familiar with site and submissions for ICH-GCP, site contract process and governor approval 

-Contribute to PI and site identification, communications, and initiation

-Contribute to site feasibility process

-Prepare for weekly project meeting based on agenda, project status and pending issues.

-Set up TC and drive the meeting

-Review protocol, ICF and eCRF amendment in collaboration with the team

-Help identify CROs and negotiate budgets
-Review and approve invoice.

-Review site monitoring reports and follow up with CRO to resolve issues

-Follow up insurance status during different stages of the trials.

-Collaboration with internal supply chain & IP vendors on IP storage and shipment procedures.

Qualifications:
-Education : Medical, Pharmacy, Biology, and Immunology department, bachelor or above

-Excellent English, especially fluent Oral English

-At least 1 years of experience in Clinical Project Management
International clinical project management experience is preferred

-Oncology project management experience is preferred

-Strong communication skills and coordination skills

-Excellent problem solving

Contact:
Please send your CV and cover letter to Peter.Qian@antengene.com

Clinical Operation Director

Title: Director/Senior Manager-Oncology, Clinical Operation
Company/Location: Antengene Corporation/Shanghai
Job Type: Onsite, Full-time employee
Reporting to: CEO

Job Purpose:
Lead execution of local or global clinical studies within budget and in accordance with established timelines and quality standards

Essential Duties and Responsibilities:
-Ensures that clinical trial projects are properly resourced, managed and executed
-Prepares required regulatory documents, CRF, ICF, annual reports, updating of the IB, and final study reports for assigned protocols
-Lead site selection and site qualification discussions.
-Managing clinical study teams/CRO to ensure the trials can be completed on time, within budget and in compliance with regulations.
-Key document preparation and review (protocols, IBs, CSRs, etc)
-Design, update and implement appropriate procedures related to clinical study development.
-Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements
-Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities

Qualifications:
-Minimum of 8 years experience in the pharmaceutical industry, with minimum 5 years direct experience in planning and managing clinical trials
-The candidate must have solid understanding of pharmaceutical clinical development process and have experience with clinical monitoring.
-The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials.
-The candidate must have a PhD/M.D. degree or equivalent; health science degree or biologic science degree is preferred.
-Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage budgets.
-Fluency in English and Chinese language (written and spoken)
-The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

Contact:
Please send your CV and cover letter to Peter.Qian@antengene.com

Medical Director

Title: Medical Manager/Director
Company/Location: Antengene Corporation/Shanghai
Job Type: Onsite, Full-time employee
Reporting to: Director, Clinical Development

Job Purpose:
Provide medical and scientific leadership to Antengene’s clinical development teams

Essential Duties and Responsibilities:
-Contribute to clinical development and registration strategy for Antengene’s diverse oncology pipeline, especially for HCC in China and global markets

-Provide overall medical and safety oversight of Antengene’s oncology clinical trials as assigned

-Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment

-Contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents

-Prepare materials for investigator meetings, participate and present in investigator meetings

-Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures

-Assist with data safety monitoring board activities

-Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriate


Qualifications:
-Graduate of an accredited medical school with at least five years of clinical development experience. 

-Experience writing clinical development protocols, IB and study reports preferred

-Experience with medical and safety monitoring

-Fluent in written and verbal English

Contact:
Please send your CV and cover letter to Peter.Qian@antengene.com