Medical Director/Associate Medical Director

Parexel International Corporation

Multiple Locations

An exciting opportunity for a Medical Director or Associate Medical Director position. We are looking for a medical doctor (MD) with strong hematology experience. Clinical trial experience is preferred. You will 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.

You will provide 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).

This role can be home-based anywhere in Europe and will involve occasional travel.

Key Accountabilities:Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLPParticipate actively in study planning with feasibility leaders, solution consultantsParticipate in team project and investigator meetingsProvide training of study teams on therapeutic 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 conduct:Answer to site/ study team questions relating to the study conduct or protocolMedical review of data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.)Timely identifying risks and challengesPro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation.Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activitiesParticipate in periodic weekly rotas for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD, e.g. be available by phone 24/7 on the assigned weekProvide risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director or Section HeadProvide medical input into pharmacovigilance workflows and projects and participate in safety processing for studies including medical review of serious adverse events.Support regulatory safety reporting activities

Client Relationship Building & EngagementActively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfactionIntegrate and put client interest and need first to build trust and demonstrate credibility, reliability, intimacy, and confidenceFollow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction.

Business Development Support Business Development as agreed with Section Head or line manager, while adequately balancing with billable tasks.In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication.Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetingsAttend preparation meeting and Bid pursuit meetings as requiredProvide support for marketing activities as requested.Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teamsCoach and mentor junior team members on effective collaboration with clients as appropriate

Medical ExpertiseProvide medical expertise to client across multiple channels and interactions such as:Consultancy 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 colleaguesAs appropriate, write clear, concise medical documentsParticipate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc.Support patient centricity, diversity and inclusion in all projects

Skills: 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 EnglishStandard computer skillsA 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.

Knowledge and Experience: Strong clinical experience in hematology, managing patients with hematologic disease, which is expected to be kept up to dateA background in clinical aspects of drug developmentGood knowledge of the drug development process including drug safety, preferredExperience in Pharmaceutical Medicine, preferred

Education: Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship)

Language Fluent in written & spoken English and local language

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2022-11-18 00:05:18


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