合资公司（国内Top one上市CRO公司和美资临床公司合资）
招聘职位：Medical Director
招聘人数：1
有效期：2013年10
职位描述：
做过oncology方面的项目
岗位职责：
GENERAL SUMMARY
Provides medical expertise for site identification, study feasibility, study design, conduct, ysis and reporting, generation of integrated databases, pooled yses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices. Also may assist Business Development group in tasks related to marketing and selling PRA services.
ACCOUNTABILITIES
• Provides medical expertise on drug development and, benefit/risk evaluations throughout life-cycle of compound
o Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical ysis Plan, and other study material, selection, and recruitment of investigational sites
o Provides continuous medical monitoring during study conduct, answering site questions on inclusion/exclusion criteria or other protocol questions, evaluation of SAEs and AEs, review of laboratory and other patient’s data, review of codes for medical history, concomitant diseases and medications, adverse events, and provides medical expertise to project team during life-cycle of study
o Assumes responsibility for ethical, e.g. medical, aspects of study
o Leads and/or contributes to discussions with regulators and/or investigators, opinion leaders, internal and external clients, and project team support
o Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
• Provides drug safety expertise for drugs, diagnostics, and devices in development and during market authorization
o Reviews Safety Management Plans, evaluates adverse events and assesses regulatory reporting requirements, generates and/or reviews notification letters to regulators, investigators, IRBs and Ethic Committees, reviews, yses and summarizes data for Data Monitoring Committees, generates and/or reviews Annual Safety Reports, protocol deviations and correspondence to health authorities, investigators, clients, and/or third parties
o Evaluates benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options, develops Safety Development Plans, Pharmacovigilance Plans, Risk Management Programs including design and conduct of safety studies
o Establishes safety systems including SOPs, Safety Database, tracking system, metrics, and serves as qualified PV person, however, the ultimate legal responsibility lies with client
• Supports generation of publications and expert reports
o Reviews and interprets study results and reports
o Generates expert reports and supports IAS/IAEs , NDAs/PLAs, and other regulatory submissions as well as generates and/or reviews publications, posters, and scientific presentations
o Evaluates spontaneous reports and literature cases, provides individual and cumulative benefit/risk assesents, communicates with reporting health care professionals, experts and consumers, reviews and authorizes Periodic Safety Update Reports, evaluates safety issues, designs and/or leads investigations, recommends interventions to clients, and contributes to hearings at regulatory agencies and/or court
• Develops and provides training
o Provides therapeutic training relevant to specific study to project team, attends and/or presents at Investigator, internal and external project team meetings
o Develops and implements training for PMs, CRAs, CSAs, CDCs, STATS, AP, DP, medical monitoring associates, medical writers; serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employees
• Supports Business Development by providing medical expertise to identify, acquire, and win new business
o Builds relationships with new customers, maintains client relationships to obtain repeat business, identifies new business opportunities through contacts, literature, and conferences
o Promotes PRA through active involvement in scientific meeting, and speaking engagements
o Contributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational execution
o Attends bid defense meetings including generating presentations and, takes active role in RFP discussions with clients
o Supports BD in client contacts to discuss portfolio and development strategies
QUALIFICATIONS
Licensed physician
Clinical practice and/or clinical research or drug safety experience preferred
Experience writing pharmaceutical or health-related documents required
Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred
Knowledge of regulatory requirements preferred
Good communications skills required
Project leadership/management skills preferred
Experience using computerized systems (PC-Windows and MS Office)
Read, write, and speak fluent English; fluent in host country language
联系
Yolanda@genhr.com，phone：13601766063/021-63931172
