葫芦岛招聘

Position: Early Development Expert (Oncology)
Report to: Head of Medical Affairs
Department: Medical
Base: Shanghai office

Overview:
Scientific input to support China Project II:
- Evaluate opportunities for China early integration into global CDP (Clinical Development Plan).
- Provide scientific input for the formulation of the global TPP (Target Product Profile) with early assessment of local needs and opportunities
- Identify local development opportunity for special medical needs and local PMO strategy


Accountabilities:
1. Strategic input:
o Provide scientific input for the formulation of the global TPP and make China early integrated into global CDP with early assessment of local unment medical needs and opportunities
2. Operational:
- Medical management level
o Take the leadership of local development project: To propose members and organize discussion
o Represent the proposal to local management team, might also in MST and Core Team for Clinical Development et al.
- Global TPP input
o Comprehensive medical analysis in asigned therapeutic area
o Identify unmet medical needs
o Identify China special needs
o As Medical Sub-Team member to represent China
o To propose China special indications to meet local special needs
- Early integration into global CDP
o Closely work with China EIDP, regional office EIDP and coroprate clinical development team to contribute scientific input
o Identify and prioritize the pipelines/indications in global CDP
o Medical assessment of global studies design, comparators to figure out if it is feasible in China
o Propose appropriate investigator list
o Get KOLs comments through in-depth discussion
- Studies espeically for China special needs
o Prepare medical part of core clinical protocols together with PSTAT and PDM if it is for China special needs
o Develop, review and approve with PDM and PSTAT appropriate sections in the PDMAP
o Review and approve together with PSTAT and PCPK the Clinical Pharmacokinetics Plan and the Population PK/PD Analyses Plans as appropriate
o Prepare core clinical trial report (CTR) jointly with PSTAT and PDM. Review and approve CTRs
o Prepare submission strategy according to SCOPE together with local DRA
o Prepare Target Master Labelling Document as basis for BPI
o Provide Medical Input to NDA meetings
o Prepare and participate in submission related consultation meetings with SFDA, and others, provide answers to medical questions
o Identify need, define and prepare the studies to be conducted as Phase IIIb/IV, hand-over to Medical Advisors
- General tasks
o Provide training on program specific standards, which support clinical monitors (TCMs ) and the consistency in both the conduct and reporting of clinical trials
o Contribute to local Publication and Communication Strategy
o Support the cooperation with the opinion leaders in the respective indication area
o Participate as medical liaison in early stage research projects before milestone Start of Development
- Key Opinion Leader engagement:
o Build relationships with KOLs to get their comments and support for early development projects
- Regulatory:
o Cooperate with DRA to provide medical and product expertise towards registration of new products/indications with regulatory authorities (CDE/ SFDA)
- Other Functional Support:
o Cooperate with Business Intelligence, marketing et al.
3. People
- Values and Behaviors:
o Consistently adhere to/demonstrate all Boehringer-Ingelheim Values/Leader Behaviors
- Learning and Development:
o Enhance self-development through on-the-job training; Talent management; Leadership
- Cross function communication:
o Good communication with China EIDP, Regional office EIDP, corporate clinical developmemt& Medical Affairs team
4. Financial:
- Relevant budget draft and and expense control
5. Technology:
- Liaison with the Business Technology function in areas such as databases, websites, interactive systems, product and health information, etc; Identify technology solutions for enabling better information availability

Skills & Competencies Requirement:
1. MD above, Oncology is preferred.
2. Both English and Chinese fluently.
3. Practical clinical experience in hospital
4. Extensive therapeutic area expertise and Pharma experience in drug development, drug safety, scientific and regulatory affairs
5. Strong knowledge of international regulations/guidelines concerning drug development and pharmacovigilance of human drugs and devices
6. Excellent strategic capabilities and analytical skills
7. Excellent organizational and decision making skills. Understand how the Matrix structure is implemented and understand what is carried out and how this effects change
8. Very good communication and interpersonal skills. Like to work in an international team - based environment
9. Have clear leadership potential

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