Responsibilities:
1. Manages the design and implementation of global clinical development programs (must include United States and China) in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements. Oversees project-related education of investigators, study site personnel, and study staff.
2. Has overall responsibility for oversight of clinical studies, medical monitoring, pharmacovigilance, overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
3. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
4. May oversee the work of Associate Medical and/or Clinical/Medical Scientists working on the same or related programs.
5. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
6. May serve on Clinical Strategy, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to asset development.
7. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with stakeholders in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
8. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
9. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
10. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications
1. Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
2. At least 7 years of clinical development on key essential documents (i.e., clinical protocol, ICF, IND/NDA submissions), medical monitoring, and pharmacovigilance experience in the pharmaceutical industry, including approximately 2 years from multinational corporation (MNC).
3. Ability to run a clinical research program of moderate complexity with minimal supervision.
4. Ability to perform and bring out the best in others on a cross-functional global team.
5. Ability to interact externally and internally to support a global scientific and business strategy.
6. Working knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
7. Key stakeholder as medical director contributed to successful IND/NDA filing with FDA and CDE health authorities.
8. Experience in successful study initiation through study completion/primary data analysis in Phase 1-2 with phase 3 preferred.
9. Must possess excellent oral and written English and Chinese communication skills.
10. There is potential for the role to be remotely with regular scheduled travel to Headquarter office.

其他信息
语言要求：英语、普通话

所属部门：临床部