Clinical Leader (Clinical Development Scientist I / II), Immunology

Job Title

CDS I (G16)

CDS II (G17)

Job Description

The CDS collects and understands the information necessary to formulate clinical development strategies. Specifically, through managing external key opinion leaders (KOLs) and collecting information at academic conferences, etc., the CDS identifies unmet medical needs in Japanese medical practice. The CDS also understands PMDA review trends, the global development strategy for the assigned asset, and the development status of competing products.

As the representative of clinical development, the CDS leads the preparation of the Japan Clinical Development Plan (JCDP) that addresses Japan's regulatory requirements and clinically feasible unmet medical needs, in accordance with the TPP, and contributes to maximizing product value. In addition, the CDS leads discussions on clinically related matters to reach agreement with Global during the preparation of the JCDP.

The CDS leads major discussions with Global and relevant regulatory authorities on clinical issues arising during the development process, including Meeting with global team and PMDA preliminary and/or official consultation, to reach agreement. In the event of conflict, the CDS proposes the most appropriate solution and works with relevant stakeholders to resolve it.

The CDS accurately interprets the clinical study results obtained and develops a submission strategy based on scientifically compelling evidence. The CDS also prepares the clinical section of the CTD and responds to inquiries from the regulatory authorities, taking relevant surrounding information into consideration.

During the study, the CDS shall: (a) In collaboration with monitoring team, oversee the reliable execution of the overall study timelines., (b) Collaborate with internal medical expert and scientist, safety management group, and monitoring team to ensure the safety of subjects in Japan,, (c)Prepare key study documents, including the scientific rationale document and clinical study report, or work collaboratively in their preparation. (,),, (d)Lead the cross functional Clinical Working Team. Clinical Working Team

The CDS collaborates with relevant departments in accordance with the Medical Collaboration Guidance (publication, meeting with Investigators, etc.).

The CDS provides appropriate information and education to internal staff as needed.

CDS I (G16)

• Conducts the above responsibilities with minimum CDH support.
• Educates lower grade colleagues with CDH.

  CDS II (G17)

  • Conducts the above responsibilities without CDH support.
  • Educates lower grade colleagues with CDH.
  • Propose and implement structures and processes to enhance overall team performance within TA in clinical development.

    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

        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.

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              Pay Range: $

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              Where We Work

              Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.