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(Senior) Medical Director, Gastrointestinal
hace 4 meses
When our values align, there's no limit to what we can achieve.
Parexel is in the business of improving the world's health.
We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.
From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.Parexel is looking for a Medical Director/Senior Medical Director with a strong background in Gastroenterology.Must have completed Gastroenterology specialty training and have clinical experience in this area.The role can be based remotely in select EMEA locations.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development.
They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects.
The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.KEY ACCOUNTABILITIES:Project Execution: Medical Monitoring Delivery & PV SupportIndependently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician)Participate actively in study planning with feasibility leaders, solution consultantsParticipate in team project and investigator meetingsProvide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management)Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/studyParticipate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc.
in conjunction with clients/sponsors or in conjunction with other Parexel departmentsDeliver medical monitoring activities according to MMP during the study conductDeliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLPProvide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse eventsClient Relationship Building & EngagementSupport Business DevelopmentProvide medical expertise to client across multiple channels and interactionsConsultancy on protocol development or drug development programMedical review of various documents, which might be audited by clients and regulatory agenciesProvide medical expertise and training to other Parexel colleagues??KNOWLEDGE & EXPERIENCE: Must have completed gastroenterology specialty training to be considered for the role.Clinical and/or research experience in MASH (metabolic associated liver disease) and/or IBDA background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution preferred.Clinical practice experienceGood knowledge of the drug development process including drug safety, preferredExperience in Pharmaceutical Medicine, preferredExperience leading, mentoring and managing individuals/ a team, preferredExcellent English language skillsEDUCATION:Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicineSKILLS:Excellent interpersonal skills including the ability to interact well with sponsor/client counterpartsClient-focused approach to workExcellent time management skillsExcellent verbal and written medical communication skillsExcellent standard of written and spoken EnglishA flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailWillingness to work in a matrix environment and to value the importance of teamwork
