Salary:70000 to 100000 yuan, 15 yuan salary
Experience requirements:8 years or more
Educational requirements:PhD
Job Description:
Job Responsibilities:
Key Responsibilities:
1. Global Strategy Oversight: Oversee the bioanalysis strategy from global development and regulatory perspectives. Design and implement operational frameworks to ensure effective collaboration and delivery of robust bioanalytical strategies. This includes, but is not limited to, endpoints such as pharmacokinetics (PK), pharmacodynamics (PD) biomarkers, and immunogenicity to support the Innovent pipeline.
2. Partnership Building: Foster effective partnerships across therapeutic areas and key stakeholders both internally and externally at Innovent. Drive the scientific strategic interface with CRO partners, establish standards (industry best practices), ensure their implementation, and drive continuous improvements.
3. Stakeholder Engagement: Drive interactions with key stakeholders across the organization, including but not limited to project leaders, clinical project leaders, finance, procurement, data management, HGRAC, clinical operations, clinical pharmacology, biomarker, BD, quality assurance, and regulatory affairs. Ensure smooth communication and alignment of goals.
4. Mentorship and Development: Provide significant mentorship and development opportunities for team members. Address complex challenges and offer solutions to facilitate personal and professional growth.
5. Regulatory and Technological Leadership: Lead regulatory interactions related to bioanalysis and evaluate/set strategies for new technologies. Stay abreast of industry trends and innovations to ensure Innovent remains at the forefront of bioanalysis.
6. Visionary Leadership: Contribute significantly to the department's vision, direction, and future investments. Work closely with the translational leadership team to shape the future of bioanalysis at Innovent.
Qualifications:
Qualifications
61 Education: PhD in Biochemistry, Immunology, Molecular Biology, Bioengineering, Bioanalysis, or a closely related field.
61 Industry Experience:
o 8+ years of relevant industry experience, preferably in pharmaceutical development.
o Proven track record as a Subject Matter Expert in preclinical and clinical bioanalysis, with the ability to design, develop, and execute bioanalytical strategies for PK, PD biomarkers, and immunogenicity assessments.
61 Project and Program Management:
o Ability to manage change in a fast-paced environment.
o Proven experience in developing assets through all stages of drug development, including understanding of the regulatory landscape and expectations.
61 Leadership and Management:
o Demonstrated ability to develop, coach, and mentor team members.
o Proven Matrix or line management experience, with the ability to manage and motivate a cross-functional team.
61 Communication Skills:
o Excellent verbal and written communication skills, including the ability to effectively present complex information to diverse audiences.
o Ability to communicate with key stakeholders across the organization, including clinical, regulatory, and business teams.
61 Additional Skills:
o Deep knowledge of global regulatory expectations and guidance related to bioanalysis.
o Ability to work independently and as part of a team, with strong problem-solving skills.
o Experience with outsourcing and vendor management.
o Familiarity with industry best practices and current trends in bioanalysis.