RESPONSIBILITIES

1. Be responsible for overall pipeline build-up strategy for small molecule drug discovery from target selection, compound screening and optimization, candidate nomination to IND filing;  and formulating discovery and preclinical development plan for small molecule innovative drugs in accordance with the overall development strategy and R&D strategy;

2. Be responsible for the formulation of specific implementation plans for small molecule innovative drug R&D projects; and to supervise, manage and guide the progress and quality of projects, and ensure that R&D related work is completed according to timeline;

3. Be responsible for the discovery and/or collaborative discovery work with external collaborators for small molecule innovative drug research and preclinical development, including candidate compound screening and evaluation, process development and technology transfer, and domestic and foreign registration;

4. Be responsible for research and evaluation of technologies and products related to small molecule innovative drugs, providing decision-making for the company's innovative drug pipeline, and providing technical support and evaluation opinions for the company's license-in opportunities of external cooperation projects;

5. Be responsible for establishing, leading and managing a small molecule drug discovery team, and constantly upgrading the research and development capabilities of the team in the area of small molecule innovative drugs.

QUALIFICATIONS

1. Major in pharmaceutical chemistry or chemistry, a Ph.D. degree; at least 10 years in a multinational pharmaceutical company or a well-known R&D institution engaged in the research and development of innovative drugs;

2. Familiar with the whole process of development of innovative drugs, with rich experience in the development and evaluation of new molecular drug innovations, and successful cases of innovative project development;

3. Strong leadership skill and experience in people management, and high standard business integrity and self-motivation.

Previous: BD Manager

Others

Regulatory Affairs Specialist

PRIMARY DUTIES:

• Support regulatory affairs management and operational processes.

• Liaison with CRO and other service providers for drug registration conduct.

• Support and track documentation and archiving for IND and NDA filing.

RESPONSIBILITIES:

• Adhere to corporate SOPs and local WIs in the assisting Project Lead with drug application planning, documentation, reporting, archiving, dossier filing, CDE review tracking, and CDE communication meeting.

• Assist in the preparation, review, modification and finalization of drug application dossiers with line functions or CRO.

• Assist in the preparation and submission of drug application package to CDE.

• Assist to track CDE review process, reply CDE question and submit supplementary documents.

• Assist in the dossier preparation, meeting request and holding, feedback tracking for CDE communication meeting.

• Assist in the regulatory documents preparation and filing requirements for clinical trial.

• Track the updates of NMPA and CDE regulatory policies, regulations and guidelines.

QUALIFICATIONS:

• At least bachelor’s degree in health science, e.g., pharmacy, pharmaceutics, medical chemistry, pharmacology, or related major; Master’s degree is preferred.

• 2-3 years industry experience in drug regulatory affairs and conduct.

• Basic understanding of ICH CTD and other guidelines, NMPA and CDE regulatory requirements.

• Familiarity with working procedures, regulations and guidelines issuance of NMPA and CDE.

• Proficiency in English (written and oral) and familiarity with standard IT office tools.

• Excellent planning, organization and problem-solving skills.

•Good communication and interpersonal skills.

Previous: CRA/ CTA

Others

Clinical Project Manager

PRIMARY DUTIES:

• Support clinical trial management and operational processes

• Liaison with CRO and other service providers for clinical trial conduct

• Support and track documentation and archiving for IND and NDA filing

RESPONSIBILITIES:

• Adhere to corporate SOPs and local WIs in the assisting Clincial Project Lead with trial planning, documentation, conduct, reporting, archiving, and clinical center/vendor invoicing.

• Assist clinical project team with meeting logistics and planning, such as advisory board meeting, investigators meeting, etc.

• Review and approve site / CRO invoices against contract for accuracy and budget track

• Prepare clincial trial meeting minutes and follow through cross-functional team actions

• Support drug supply management and drug depot for shipping, labeling, packaging and hospital storage tracking.

• Review and track all vendors and clinical center invoices against contract scope of work, and ensure invoices are accurately reconciled and paid.

• TMF are archived at the time of trial completion/closure.

QUALIFICATIONS:

• At least bachelor’s degree in health sciences, e.g., pharmacy, nursing, biochemistry, medicine or related major; Master degree is preferred.

• 2-3 years industry experience in clincial trial management and conduct.

• Basic understanding of ICH guidelines, GCP and regulatory requirements.

• Proficiency in English (written and oral) and familiarity with standard IT office tools.

• Excellent planning, organization and problem-solving skills.

• Good communication and interpersonal skills.

Previous: Regulatory Affairs Specialist

Others

Clinical Project Manager / Sr. Clinical Project Manager

PRIMARY DUTIES:

Management of clinical research project in China

Vendor (CRO, Lab, drug storage, etc.) supervision and management to ensure quality and timelines

Liaison with KOLs and support scientific meetings and publications

Support IND and NDA filing

Quality control of the clinical research projects, such as co-monitoring visit

RESPONSIBILITIES:

Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.

Provide leadership in clinical trial conduct, including but not limited to CRO and site selection and activation, protocol implementation and quality control, management of project progress and timelines.

Review and approve study documents, e.g., site feasibility survey, ICF, CRFs, protocol, CSR, etc.

Prepare Monitoring Manual and ensure compliance and consistent with study protocol and SOP.

Contact with CMC department regarding design of labeling, packaging and drug logistics.

Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and identifying issues, maintaining records.

Support contract review and negotiation with study sites.

Oversee study budget and verify site and vendor invoices related to related tasks.

Participate in regular cross-functional Data Quality Review and lead query resolution actions.

Conduct co-monitoring visits when needed, and review monitoring reports.

Ensure all vendors and sites invoices are reconciled and paid, and TMF are archived at the time of trial completion/closure.

QUALIFICATIONS:

At least bachelor’s degree in pharmacy, nursing, biochemistry, medicine or related major; Mater degree is preferred.

3-5 years industry experience with proven proficiency in clinical research. management for drug development.

Good understanding of ICH guidelines, GCP and regulatory requirements.

Proficiency in English (written and oral) and familiarity with standard IT office tools.

Excellent planning, organization and problem-solving skills.

Good communication and interpersonal skills.

Previous: CRA/ CTA

Others

BD Manager

Job description:

Responsible for technology-based licensing and partnering and managing alliance with industrial and academic partners.

Identify and establish relationships with biotech and pharmaceutical companies.

Lead licensing and partnering projects including negotiation, transaction and alliance management.

Qualification:

Master’s degree or Ph.D. in life science, medical or pharmaceutical science;

5+ years of business development/marketing/product management experience；

Knowledgeable in B2B business;

Sharp business acumen, strong sense of potential business opportunities;

Strong communication and interpersonal skills, capable of working with different functions internally and externally;

Strong project management;

Analytical abilities and time management skills are necessary;

English skills in terms of oral and writing English;

Previous: Clinical Project Manager

Others

SVP, Head of Discovery (Small molecule)