Job Responsibilities：

For the assigned program/project(s) with minimum support by function head / seniors:
1.  Lead the research/development Team, including but not limited to: stakeholder management, team alignment, team meeting and communication, team setup and deliverable status check, collaborate with other project teams.
2.  Work with the team and stakeholders to develop product development plan
3.  Contemplate study design for each clinical trial and prepare study concept according to the development
4.  Ensure the best medical science parts are incorporated into the development plan of the assigned projects
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
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.

Job requirements：

Education Level: Master and above

Experience:
1.  Understand and apply scientific principles to the 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 5 years of relevant experience in biopharmaceutical-clinical development (or equivalent) is required including the followings:

a) Oversight of the planning and simultaneous management and reporting of multiple clinical studies.

b) 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).

c) Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred.

d) Current knowledge of most aspects of the global clinical development processes / global studies required.

e) The knowledge of relevant therapeutic area preferred.

3.  Actual experiences for authorities' consultation, authorities' review and negotiation processes to obtain approval are also preferable

Competencies:
Management & Leadership Skills:
1.  Project management
2.  A participative and engaged management style
3.  Ability to build effective team relationships with colleagues at all levels in the organization
4.  Be capable of adaption to changing and complicated environment

Decision Making:
1.  Manage uncertainty
2.  Ability to work independently, to solve complex problems, and oversee multiple projects in supervisory capacity
3.  Ability to manage conflict and achieve consensus in a team through open discussion and deliberation

Communications:
1.  Demonstrates clear and articulate verbal, written and presentation skills with good command of the English &Chinese and represent NeuroFront at meetings and congresses

Problem Solving:
1.  Mitigate risks for responsible tasks with risk based approach
2.  Detect problems and identify issues for potential root cause analysis
3.  Design and implement improvement plans as needed for continuous improvement
4.  Be able to implement preventive actions to issues