Johnson & Johnson Careers

Senior TA Manager

Beijing, Beijing
Clinical Trial Administration


Job Description

Requisition ID: 1805655435W

General job accountability:

·         Act as clinical leader for the assigned compounds, responsible for China clinical development strategy and CDP in line with TPP and global development plan

·       Accountable for all clinical deliverables according to Clinical Development plan.

 

Principal accountability and internal and external contacts:  (Please attach other paper if needed)    

 

     A. Primary responsibility

·         Act as Clinical Leader, lead the clinical development for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds).

·         Responsible for China clinical development strategy and CDP in line with TPP and global development plan.

·         Deeply understand global clinical development strategy and plan. Lead cross-functional team to development and drive CD strategy and plan, and ensure the clinical development plan fully aligned with China and globally (for some specific China R&D driven compounds). Keep the China clinical development plan updated.

·         Propose clinical study design and develop clinical study protocol based on the clinical development plan. Be accountable for all clinical deliverables (e.g. clinical study reports and submission summary / HA response document, contribute to HA interactions, such as CDE panel meeting and responsible for the clinical questions, etc.)) if applicable. Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Provide physician guidance and expertise on patient care to clinical studies (including medical monitor, etc.) if necessary.

·       Provide clinical input for commercial assessment and portfolio prioritization. Communicate and cooperate with internal and external customers. Develop and maintain close academic  relationship and collaboration with KOLs and other critical stakeholders. Undertake tasks as agreed with the TA Lead.

B. Contacts of key internal and external stakeholders

Internal

External

Cross- function teams in China R&D (e.g.  RA,  GCO, Statistics, Discovery, MAF, PMO etc.)

Hospital/KOL

Strategic marketing/marketing  team

Specialized medical association and other key stake holders

Regional/global TA person in charge

Clinical leader and other relevant clinical persons and global TA


Qualifications

Qualification and competency requirements

 

A.        Education /Training background:

MD. is mandatory; MSc. or PhD is an asset.

B.        Knowledge/Skills:

·         Thoroughly understand and command knowledge of product and relevant diseases

·         Solid knowledge of clinical development process and HA (especially CFDA) requirements

·         Thoroughly understand and command GCP

·         Thoroughly understand and command HCC

C.        Job experience:

At least 3-year clinical practice in relevant therapeutic area and 3-year working experience in pharmaceutical industry (especially clinical development, and people management) is preferred

D.        Competency:

Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.

E.         Others:

Excellent English abilities of listening, speaking, reading and writing; same level of CET-6


Primary Location
China-Beijing-Beijing
Organization
J&J (China) Investments Ltd (7046)
Job Function
Clinical Trial Administration
Requisition ID
1805655435W