Shanghai, China (Hybrid)
The Associate Medical Director / Medical Director will provide medical, clinical and scientific advisory expertise to all divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. Provide therapeutic and medical expertise to business development activities.
Essential Functions
•Open for homebase.
•The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.
•Primarily serves as Global and /or Regional Medical Advisor on assigned projects.
•Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
•Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
•Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
•Provides therapeutic area/indication training for the project clinical team.
•Attends and presents at Investigator Meetings.
•Performs review and clarification of trial-related Adverse Events (AEs).
•May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
•May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
•May perform medical review of adverse event coding.
•Performs review of the Clinical Study Report (CSR) and patient narratives.
•Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
•Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
•Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
•Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
•Attends and presents at bid defense meeting, as required.
•Participates in strategic business development activities including presentations to prospective clients.
•Maintains awareness of industry development and may author related publications.
Qualifications
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license.
Major in respiratory/dermatology/cardiovascular/gastroenterology or have relevant working experience in these area.
Typically requires 7 - 10 years of prior relevant experience. Ideally, candidate will have a minimum 2 years clinical trials experience as an investigator or medical /clinical expert in the Pharma, CRO, or Biotech industry.
Fluent English in both oral and written.
TO APPLY - Please forward resume/CV to Amanda Sonus at asonus@pailingroup.com
pailingroup.com
