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
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