Clinical Development Scientist, Neurology

Purpose Statement: 
Clinical Development Scientist (CDS) as the leader of clinical development in Japan contributes to the development management and execution of the clinical development strategy based on medical scientific and regulatory principles in collaboration with internal and external stakeholders for the purpose of delivering the most efficient clinical development strategy to achieve the fastest approval of the responsible asset. 

(CDS)

Major Responsibilities:
1.    CDS as the representative of the clinical development team is responsible for developing the clinical development strategy including the clinical data package and clinical study design and conducts the associated key regulatory discussions including face-to-face advice and prior interviews with the PMDA. 
CDSPMDA

2.    During the course of a clinical study CDS is responsible for:
CDS
(a)    The oversight of the clinical studies and review interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. In collaboration with the monitoring team CDS is responsible for the oversight of overall timelines for key deliverables.

(b)    Taking part in the study safety monitoring in collaboration with internal medical expert and safety management group. 

(c)    Preparing core clinical documents including the Clinical Study Report.
()

3.    CDS prepares the clinical part of CTD and deal with the associated inquiries from the regulatory authorities.
CDSCTD

4.    CDS is responsible for the development of the core contents of publications including presentations at academic conferences and manuscripts.
CDS

5.    CDS acts as the clinical interface and actively solicits key opinion leader (KOL) interactions; partners with cross-functional team members including cross-functional team leader Medical Affairs Commercial and other functions in these activities as required to ensure that broad cross-funcitonal perspectives are incorporated into the development management and execution of the clinical development strategy.
CDS(KOL)CDS

6.    CDS oversees project-related education for local AbbVie study staff as appropriate in consideration of local medical/scientific environment.
CDS

CDS I (G16)
    Conducts the above responsibilities with his/her superiors minimum oversight/support. 
    Educates lower grade CDS/associate CDS with his/her superior.
/
CDS

CDS II (G17)
    Conducts the above responsibilities without CDH oversight/support.
    Educates lower grade CDS/associate with CDH.
CDH/
CDHCDS
 

Qualifications :

/ Background/Experience
    At least 5 years experience in clinical development or equivalent knowledge of clinical development.
5

/ Education
    Graduate from Medical School College of Nursing College of Pharmacy College of Science/Agriculture or life-science course (Holder of master degree or PhD degree is preferable) or equivalent education 
/
    Preferred holder of Medical Doctor Veterinarian Pharmacist or other related with life-science related degree or license

Leadership Behavior/Mindset
    Set Vision        
    Anticipate        
    Innovate        
    Build            
    Deliver Results        
Knowledge
    Clinical Development experience for assigned therapeutic area equivalent clinical knowledge and/or capability to acquire equivalent knowledge. 
/
    TOEIC is 800 score or higher or equivalent skill for English communication. 
TOEIC 800
Skill
    Leadership
    Coaching
    Team building
    Communication (in Japanese and English)
    Facilitation
    Medical writing

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No