Principal Scientist, China Clinical Pharmacology

4 weeks ago

Shanghai, China Roche Full time

The Position

Position:
We are seeking a highly motivated, dynamic, and experienced leader to lead strategic Clinical Pharmacology support for the China development projects supported by the Clinical Pharmacology Department at Principal Scientist will develop, oversee and lead the strategy and execution of efforts to support the increasing portfolio and regulatory needs in China, including small molecules, antibodies, antibody-drug conjugates, bispecifics, antibody SC and device bridging in all therapeutic areas. The successful candidate will be a forward-thinking scientific and strategic leader with a strong and compelling vision for Clinical Pharmacology in China and will have a keen understanding of regulatory guidelines from China health authorities that shape drug development strategies for China. The candidate will also be capable of leading across diverse regions, cultures, and time zones, and create an environment of belonging, inclusion and diversity. With an increase in the speed, complexity and diversity of molecules and therapeutic areas in our portfolio and rapidly evolving China regulatory environment, this leader should have extensive global clinical pharmacology and drug development experiences and strong influencing vision, working in close partnership with other clinical pharmacology scientists, expert reviewers, group leaders, China project team leaders, as well as key cross-functional stakeholders and external academic/industrial/regulatory leaders across diverse disciplines. The candidate should be fluent in both English and Mandarin.

Scope of the position:
The Principal Scientist will be responsible to develop, oversee and lead the overall China Clinical Pharmacology strategy, as well as near- and long-term strategic and scientific focus and vision for China Clinical Pharmacology. As Subject Matter Expert (SME) for China regulatory guidelines and environment, the leader will provide consultation and guidance for other Clin Pharm scientists, expert reviewers, and group leaders (as needed) to support Clinical Pharmacology need in China for all the gRED molecules in the China portfolio in all therapeutic areas. The leader will be responsible for relationship-building with CDE reviewers and local academic/industrial leaders. The China portfolio currently includes > 20 gRED molecules in Oncology, Immunology, Ophthalmology and Neurosciences.

Responsibilities:
Key roles and responsibilities include, but are not limited to the following:

● Develop, oversee and lead the overall China strategy and long-term strategic vision in China Clin Pharm with an innovative and patient-centric mindset. Assure alignment with both departmental and portfolio goals. 
● Strong internal and external presence and influence as a China Clin Pharm scientific & strategic leader
o Effective relationship-building and influence with the China health authority CDE reviewers) and local academic/industrial leaders in China
o Attend F2F meeting with CDE to support portfolio and scientific discussion
o Effective relationship-building and influence with internal stakeholders like SSF-based Clin Pharm Scientists, China Clinical Sciences, China Regulatory Sciences, Data Science, DMPK/PTPK, Biomarkers, Bioanalytical Science, Informatics, Clinical Safety, pRED China Clin Pharm 
o Be a member in the PD China leadership & governance team and contribute to the strategic and scientific discussion on China development 
● Effective leader and mentor as the China Clin Pharm and regulatory SME
o Exhibit strong leadership by working effectively in a matrix organization, creating a positive work environment while inspiring and influencing others, encouraging mutual respect, instilling innovation and clear accountability at the program and study levels, in order to deliver critical clinical pharmacology deliverables in support of the China portfolios
o Develop people training on evolving China regulatory guidelines and environments in close partnership with other leaders in Clin Pharm to ensure effective development of Clin Pharm staff. Provide support and mentorship as SME via expertise and knowledge sharing.
o Provide consultation and guidance on China development strategy, healthy authority CDE) interactions and documents as needed for the China portfolios, by working with the molecule SME and may serve as a China Clin Pharm expert reviewer for regulatory documents and participate in the CDE meetings (F2F and TC) as needed.


Requirements:
The ideal candidate will satisfy many of the following requirements: 

The candidate should have a or an equivalent degree in pharmaceutical or life sciences with 8+ years of experience in Clinical Pharmacology. A proven track-record of scientific and drug development achievement, deep understanding of R&D process and China regulatory guidelines and environment, as well as demonstrated cross-functional leadership experience is required. Very strong verbal communication skills accompanied by outstanding writing skills in both English and Mandarin are required. The ability to effectively interact with and influence health authority and senior leaders in China clinical development is critical for success. The candidate should thrive and work well in a fast-paced, multi-tasked, and hands-on environment.

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