Clinical Development Scientist Immunology

Purpose Statement:
Clinical Development Scientist (CDS) as the leader of clinical development in Japan contributes to the development management and 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 facetoface 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 crossfunctional team members including crossfunctional team leader Medical
Affairs Commercial and other functions in these activities as required to ensure that broad
crossfuncitonal perspectives are incorporated into the development management and
of the clinical development strategy.
CDS(KOL)
CDS

6. CDS oversees projectrelated 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 :

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 lifescience course (Holder of master degree or PhD degree is preferable) or equivalent education
/
Preferred holder of Medical Doctor Veterinarian Pharmacist or other related with lifescience 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

:

AbbVieAbbVie

Remote Work :

No

Employment Type :

Fulltime