Associate Medical Director
India, RemoteAdditional Locations: India-Bengaluru-Remote; India-Mumbai-Remote Job ID R0000033129 Category Medical Sciences
About this Role
Associate Medical Director
Job Purpose:
The Associate Medical Director is a medical expert with specialized therapeutic expertise and is gaining 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
Accountability
Project Execution: With guidance, 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 (generally Regional Lead Physician, Global Lead Physician if appropriate).
Delivery & PV Support:
• Participate actively in study planning with feasibility leaders, solution consultants
• Participate in team project and investigator meetings
• Provide 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/study
• Participate 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 departments
• Deliver medical monitoring activities according to MMP during the study conduct:
• Answer to site/ study team questions relating to the study conduct or protocol
• Review and sign off all 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.)
• Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned (GLP or RLP) by
• Timely identifying risks and challenges,
• Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation.
• Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study.
• Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities
• Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD
• Provide risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director or Section Head
• Provide medical input into PV 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 & Engagement:
• Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction
• Follow 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 time 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 meetings.
• Attend preparation meeting and Bid pursuit meetings as required
• Provide support for marketing activities as requested.
• Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams
Medical Expertise:
• Provide medical expertise to client as contracted across multiple channels and interactions such as:
• Consultancy on protocol development or drug development program
• Medical review of various documents, which might be audited by clients and regulatory agencies
• Provide medical expertise and training to other Parexel colleagues
• As appropriate, write clear, concise medical documents
• Participate 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.
Skills:
• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
• Client-focused approach to work
• Excellent time management skills
• Excellent verbal and written medical communication skills
• Excellent standard of written and spoken English
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork.
Knowledge and Experience:
• Experience in clinical medicine (general or specialist qualifications) with a specialty in a “therapeutic area,” which is expected to be kept up to date
• Clinical practice experience
• A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred
• Good knowledge of the drug development process including drug safety, preferred
• Experience 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)
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