Job Number:

External Description:

JOB SUMMARY

For the assigned program/project(s) in the region:
1)    Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work.
2)    Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and reflected in the CDP. Such expertise may include but not limited to key opinion leaders, global Patient Value Unit, regulatory affairs experts, project/study physicians, project management, biostatisticians, and pharmacologists.
3)    Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
4)    Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
5)    Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
6)    Guide the team through data analyses and review to conclude for study result interpretation.
7)    Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTNs and NDAs.
8)    Contribute to establish "Center of Excellence" in clinical development in Asia. 
[If the person is M.D. and it requires]
1)    Oversight CRO's medical monitoring activities and educate medical monitors
2)    Contribute to safety evaluations to ensure participating patients' safety in clinical studies.

MAJOR ACCOUNTABILITIES

For the assigned program/project(s) in the region:
1)    Lead the Development Team, including but not limited to: stakeholder management, team alignment, team meeting and communication, team goal setup and deliverable status check, collaborate with other project teams such as EAST, JCST, ST.
2)    Work with the team and stakeholders to develop CDP for the region/country. 
3)    Contemplate study design for each clinical trial and prepare study concept according to the CDP.
4)    Ensure the best medical science parts are incorporated into the CDP of the assigned clinical program/projects, including study design discussion, protocol concept / protocol development, and other related documents.
5)    Oversee the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators.
6)    Drive the implementation of the CDP for timeline, budget and deliverables; provide technical guidance to the operational team when needed; identify potential risks and manage any challenges that may occur.
7)    Lead the team in data analyses and result interpretation for studies.
8)    Represent the company at meetings with Regulatory Authorities and/or partners as necessary.
9)    Represent the company and speak at conferences and meetings with Key Opinion Leaders as necessary.
10)    Ensure compliance of program/project(s) with all appropriate regulations, SOPs, company processes and ICH-GCP and quality standard applicable to company.
11)    Construct the submission logic for clinical part of CTD/eCTD and any other regulatory documents.
12)    Lead and drive clinical part of submission team to establish quickest time from LPLV to NDA.
13)    Coach / Mentor junior staff.

EDUCATION & QUALIFICATION

Education Level : Bachelor's Degree

Experience :

 1)    Understand and apply scientific principles to clinical development strategy / trial design as well as data acquisition, analyses, and reporting. Apply fair balance in data interpretation.
2)    Depending on previous professional experience, more than 7 years of relevant experience in biopharmaceutical-clinical development (or equivalent) is required including the followings: 
-    Oversight of the planning and simultaneous management and reporting of multiple clinical studies. 
-    Broad experience in writing and/or participation in the preparation of submission documents required (across or at timepoints along the continuum from original protocol to NDA/PLA to safety updates). 
-    Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred. 
-    Current knowledge of most aspects of the global clinical development processes / global studies required.
-    The knowledge of relevant therapeutic area preferred. 
3)    Actual experiences for authorities' consultation, authorities' review and negotiation processes to obtain approval

COMPETENCIES

MANAGEMENT AND LEADERSHIP SKILLS:
    Project management skills. Formal project management training a plus
    Listening, coaching, mentoring, facilitation and negotiation skills
    A participative and engaged management style
    Ability to build effective team relationships with colleagues at all levels in the organization within and outside of Clinical Science / GCD Japan
    Ability to lead in a matrix environment
    Be capable of adaption to changing and complicated environment
DECISION MAKING:
    Can manage uncertainty
    Ability to work independently, to solve complex problems, and oversee multiple projects in supervisory capacity
    Ability to manage conflict and achieve consensus in a team through open discussion and thorough deliberation 
COMMUNICATIONS:
    Demonstrates clear and articulate verbal, written and presentation skills with good command of the English & Local language and the appropriate composure to represent company internationally at meetings and congresses and to provide leadership and mentoring for people in cmpany
ACCOUNTABILITY & FINANCIAL MANAGEMENT:
    Explain functional policies, goals and prioritization
    Accountable for team goals, budget
    Define standards and procedures
PROBLEM SOLVING:
    Mitigate risks for responsible tasks with risk based approach
    Detect problems and identify issues for potential root cause analysis
    Design and implement improvement plans as needed for continuous improvement
    Be able to implement preventive actions to issues
    Show clear direction to lead others based on solid understanding of business situation

Job Number:

Community / Marketing Title:
Clinical Development Lead

Location_formattedLocationLong:
Tokyo, Tokyo JP