H**********J
发帖数: 351 | 1 Primary Responsibilities and Accountabilities:
On the ED Core Team
• Represents medical science on ED Teams to
o ensure alignment on strategy between ED and LIP Criteria
o support target and clinical candidate selection (in collaboration with
Clinical Pharmacologist)
o provide guidance on benefit/risk assessment and risk mitigation
activities (responsibility shared with Clinical Pharmacologist)
• Is accountable for the overall design and the clinical and
scientific content of Early Development Medicine studies to evaluate and
validate targets and or assess MoA..
• Propose, establish and lead external collaborations to address
strategic and tactical needs of agreed translational science and PoC
strategies
• Work in partnership with the Biomarker scientist to define and
develop biomarker strategies
Through the Early Development Phase
• Ensures the timely development of the pRED-CDP including the
biomarker strategy and Proof of Concept scenarios to ensure fast and
efficient assessment of the clinical candidate and fact-based go/no go
decisions for the molecule or the program.
• Medical lead in the exploratory phase accountable for ED
deliverables at the project level and leads the ED team.
• Works with the Clinical Pharmacologist and Biomarker Scientists
to ensure the clinical data package will be meeting LIP Criteria for
transition to later development and will support the Target Product Profile.
• Responsible for budget and manpower planning for the early
development phase of the program.
• Assures GCP, Clinical Operating Guidelines and Standard Operating
Procedures are followed where appropriate.
• Represents the main interface with Clinical Operations for
project-related activities, specifically for larger scale PoC studies in
patients.
• Develops protocols for PoC studies and supports protocol
development for Experimental Medicine and Clinical Pharmacology studies.
• Key medical interface with Business and Research.
• Responsible for safety/pharmacovigilance risk management planning
• Co-ordinates preparation of abstracts, posters, and papers for
scientific meetings/publication plans.
• Participate in evaluation of licensing opportunities, as required
, by pRED ChinaT.
During Confirmatory Phase Development
• Collaborate with the clinical pharmacologist and, where required,
define and lead exploratory translational science activities to support
life cycle team and/or disease area strategies
Personnel:
• Allocates resources and is accountable for the assignment of his/
her collaborators/reports according to their individual capabilities and in
line with the projects priorities.
• Is accountable for performance management and the career
development plans of his/her collaborators/reports and actively ensures that
they receive appropriate management and technical support and training,
including required training in SOPs. Contributes to orientation and training
for employees and signals further educational or training requirements.
• Selects, interviews and makes hiring recommendations in the
reporting area. | H**********J
发帖数: 351 | 2 上海罗氏研发中心的职位信息
任职要求：
Education/Qualifications:
MD PhD in a relevant field
Minimum:
MD in a relevant field with subspecialty training or experience OR
PhD in a relevant field and a significant experience in a translational
medicine discipline or field
MD PhD , MD or PhD candidates must have a proven record of scientific
achievement as evidenced by presentations and publications in peer reviewed
journals and a minimum of 4 years post doctoral experience.
Strongly desired:
Significant experience in pharmaceutical medicine or drug development
邮箱：j****[email protected] |
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