Clinical Development Scientist Oncology

Expected job grade are G16 or G17 (Depending on the career experiene and evaluation) 

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. 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

1. During the course of a clinical study CDS is responsible for:

CDS

1. 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 including the management and submission of the Clinical Trial Notification (CTN).

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

1. Preparing core clinical documents including the Clinical Study Report.

()

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

CDSCTD

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

CDS

1. 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 execution of the clinical development strategy.

CDS(KOL)CDS

1. CDS oversees projectrelated education for local AbbVie study staff as appropriate in consideration of local medical/scientific environment.

CDS

CDS II

Conducts the above responsibilities without CDH oversight/support.

Educates lower grade CDS/associate with CDH.

CDS I

Conducts the above responsibilities with minimum

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