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Please check our open positions below. If you don’t see a position that is a good fit and would like to learn more about our team, feel free to Contact Us to see how you can make a difference at Terns.

General

Job Title: Clinical research physician

Function: Clinical development

Base: Shanghai

Report to: Head of Clinical Research & Operation

Band: 4/5

 

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

 

Job Purpose

Clinical research physician’ s job is to drive the clinical development of compounds by applying clinical, scientific and drug development skills that meet the needs of the patients and other customers of our company.

Major Accountabilities

•      Develop/review clinical trial protocol, IB, ICF, CSR, etc., medical materials

•      Act as physician and monitor medical events during clinical trials operation phase

•      Develop/review publications according to finished clinical trials

•      Contribute medical input in pipeline/product strategy

•      Give medical input in regulatory interactions
•      Give medical input in cross-function interactions
      

Background / Prerequisite

•      Medical doctor with additional specialty training
•      Above 3 years clinical practice
•      Fluent English

•      Documented experience in lab/clinical research experience

 

Measurement of success

•      Quality

•      Consist

•      Courage to facing difficulties

•      Ownership for what have done

•      New role/function knowledge learning

 

Document prepared by: Terns China Technology

Date of issue: 2018

Email: connect@ternspharma.com

Function: Clinical operation

Base: Shanghai

 

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

 

Job Purpose

Clinical Project Manager will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Will be a key member of the clinical project team working closely with the Medical Leader and other key function, will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan.

Major Accountabilities

•      Develop clinical trial strategy and plan in collaboration with CRO and internal functions.

•      Ensure successful completion of clinical studies that are on time, within budget and with high quality. Accountable for ensuring all needed aspects in clinical operations (drug, resources, contracts, budgets, trainings, meetings, documentations, etc.) are identified, planned and implemented in timely manner. Proactively identify potential issues/risks and mitigate, generate contingency plans and mitigation plans when necessary.

•      Manage and monitor performance of all CROs and vendors to ensure successful completion of drug development program with regard to timelines, budget and quality.

•      Manage the budget, contract requirements to ensure that trials/development program plans are on target.

•      Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.

•      Review clinical data and metrics to identify trends.
      

Background / Prerequisite

•      Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.

•      Experience working in managing clinical trials and operation

•      Good working knowledge of GCP and ICH guidelines

•      Title and compensation commensurate with qualifications and experience

•      Proactive and organized with exceptional follow-up

•      Anticipate/ identify problems and takes appropriate action to correct

•      High degree of accuracy with attention to details

•      Excellent team player


Document prepared by: Terns China Technology

Date of issue: 2018

Email: connect@ternspharma.com

General

Job Title: CMC Formulation Expert

Function: CMC

Report to: Head of CMC

 

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

 

Job Purpose

Responsible for the whole development cycle of drug product with a particular focus on later phase development (Commercial formulation and process development / Ph IIb & Ph III manufacturing / Technology transfer). Map and execute the plan for drug product from FIH (First In Human) to NDA (New Drug Application) according to project timeline. Work closely with chosen CMOs, and provide timely feedback to management on possible impact to project timeline. Supervise junior members of formulation group and provide guidance from technical and program perspective. Author / review DP related regulatory documents and interact with Health Authorities (FDA / EMA / NMPA) in order to obtain regulatory approval.

 

Major Accountabilities

•      Map the DP development plan from FIH to NDA to support the R&D portfolio

•      Actively identify and address the bottleneck of drug product development and accelerate the overall progress whenever possible (stay out of the critical path)

•      Interact with chosen CMOs on a daily basis and provide critical inputs on experiment design & objectives, data collection & format, interpretation of results, etc

•      Fully in charge and be responsible for commercial formulation and process development with internal and external resources, and plan budget and arrange FTE accordingly

•      Work with CMO to successfully deliver the drug product for Ph II & Ph III in a compliant way, including the appropriate data sets and documentation

•      As the point of contact for drug product, provide inputs / feedback to management team on project updates and alert management on possible delay / change of timeline whenever necessary

•      Work with CMO to write and review the DP section for regulatory submission

•      Communicate with FDA / EMA / NMPA on any questions / issues related to drug product

 

Background / Prerequisite

•      Ph.D. in formulation / pharmaceutics from an oversea university or significant oversea experience, with 5-8 year working experience in solid oral formulation R&D

•      Outstanding command of English and capability to communicate fluently in English

•      Prior experience in formulation and process development intended for commercial launch required

•      Prior experience in technology transfer and / or manufacturing setting highly preferred

•      Working knowledge in pre-formulation / salt & polymorph / novel formulation

•      High energy, quick learner, collaborative and experience initiating, be a high driver in a new start company.

 

Document prepared by: Terns China Technology Co., Ltd.

Date of issue: 2018 Nov

Email: connect@ternspharma.com

General

Job Title:  CMC/Preclinical (Sr.) Manager

Department: CMC

Reports to (Job Title): Head of CMC

 

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

 

Job Purpose

Responsible for managing / coordinating preclinical studies of Terns programs at CROs, particularly studies of toxicology. Also responsible for support and review of related study reports and regulatory filings in IND/NDA.

 

Major Accountabilities

•      Responsible for management of preclinical studies at CRO, particularly studies of toxicology

•      Regular briefing to Terns management on progress / timeline and issues to be solved for relevant studies

•      Interact with Terns project teams on study updates and impact on overall project

•      Prepare budget plan for the next three years and periodically update finance on changes / modifications

•      Support and review study reports and regulatory filing

      

Background / Prerequisite

•      Master’s degree in a related field, with at least 5-year experience including as a study director, or Ph.D. plus 2-year experience as a study director

•      Deep understanding of pharmaceutical industry, with experience in both CRO and drug R&D preferred

•      Fluent English in professional field

•      High energy, quick learner, collaborative and experience initiating, be a high driver in a new start company.

 

Measurement of success

•      Smooth project execution according to agreed upon timeline

•      Effective communication with project team and consultants on study design & updates

•      Study reports and RA filings conform to ICH standard, no significant findings from HA

 

Document prepared by: Terns China Technology Co., Ltd.

Date of issue: 2018

Email: connect@ternspharma.com

General

Job Title: Director of Clinical QA

Function: Clinical Auditing Compliance

Base: Shanghai

Report to: TBC

Band: 3

 

Background

Terns China Biotechnology is a clinical-stage pharmaceutical company developing novel small molecule therapies for liver-related metabolic and oncological diseases.

 

Job Purpose

To partner with internal and external business partners in driving quality into the clinical development portfolio across Terns sites and departments and provide Clinical QA input to cross functional teams dealing with complex and/or important projects and issues.

 

Major Accountabilities

•      Develop/review clinical trial protocol, IB, ICF, CSR, etc., medical materials

•      Helps to build knowledge of the company SOP’s and customers

•      Solves a range of moderately complex problems related to GxP: analyses possible solutions and assesses each using standard procedures and pragmatic approach

•      Developed competence in a variety of work processes, activities or disciplines

•      Helps to build knowledge of company SOP’s and customers

•      Decisions are guided by policies and procedures and receives oversight and guidance from

•      Continually strives to develop new methods

•      Achieves results that are aligned with the project target

•      Identifies risks and proposes pragmatic and reasonable corrective actions in complex situations

•      Applies appropriate strategies and option-based rationale

•      Applies best practices, principles and theories in complex business situations and issues

•      Gives input based on expertise and awareness of business implications

•      Implements risk-based approach

•      Takes innovative approach to working practices while ensuring compliance

•      Handles complex situations

•      Develops efficient processes or solutions without active supervision

•      Involved in difficult or sensitive projects

 

Background / Prerequisite

•      Global and forward thinking, GxP mindset with expertise in GCP

•      Capable of auditing and supporting global/local clinical and (future preclinical) quality assurance efforts

•      Strong GCP skills, ability to audit vendors and systems, understand and review CAPAs related to audits

•      Ability to audit sites in instances of potential fraud or misconduct

•      Engaged and engaging

•      Capable of understanding and interpreting dynamic regulatory environment and aligning with operational expectations and needs to direct clinical quality efforts

•      Understand and be comfortable with risk-based auditing

•      Have global pharma or CRO experience; 3-5 years with increasing responsibility and accountability

•      Capable of understanding impact of local activities within global paradigm

•      Influences senior management and external peers on project and quality related issues

•      Leads project related teams within area of expertise

•      Takes initiative to identify and deal with issues within area of expertise

•      Sets objectives for (project) teams and provides feedback that enable the team to perform at their best

•      Makes maximum use of resources to achieve expected results

•      Empowers and motivates teams

•      Identifies need for management of change and recommends appropriate methodologies

•      Coaches, mentors and trains colleagues as requested by line management

•      Delivers or provides input to training programs within area of expertise

•      Capable of leading and motivating interdepartmental teams

•      Inspires confidence at senior levels through influencing skills and technical ability Demonstrated professional maturity in stressful situations or conflicts

•      Knows how and when to give praise/recognition or constructive feedback

•      Thorough understanding of business and cultural drivers

•      Skilled and experienced at operating in a cross-cultural team environment

 

Document prepared by: Terns China Technology Co., Ltd.

Date of issue: 2018 Nov.

Email: connect@ternspharma.com