Parexel
Associate / Medical Director - Rheumatology (home-based, US)
Parexel, Raleigh, North Carolina, United States
Associate / Medical Director - Rheumatology (home-based, US)
Bring your Rheumatology experience and Lupus expertise to an Industry Leader, Parexel! Building on our continued success, we are expanding our esteemed Medical Sciences Team and seeking an Associate/Medical Director to support the growth of our Global Immunology and Inflammation Therapeutic Franchise.
Overall responsibilities of the Associate / Medical Director are to:
Provide medical and safety monitoring for assigned projects
Provide medical expertise and leadership to support business development and pre-award activities
Supporting Activities
Medical Support / Medical Monitoring for projects and studies contracted to Parexel
Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor and the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP)
Participate actively in study planning with feasibility leaders and solution consultants
Participate in team project and investigator meetings
Provide training of study teams on indication and protocol (Note that this does not include direct medical advice on patient care or management)
Communicate with relevant sponsor counterparts on project challenges and accomplishments
Develop and review study documents such as clinical protocols, Medical Monitoring Plans (MMP), clinical and statistical summary reports, safety plans, informed consent forms, etc.
Deliver medical monitoring activities according to the MMP during study conduct
Answer site/study team questions relating to conduct or protocol
Review and sign off all data listings, protocol deviations, and datasets for medical accuracy and consistency
Provide medical leadership to the project in close coordination with the Project Leader, identifying risks and proposing actions to mitigate them
Attend and support audits or inspections pertaining to assigned studies even when not directly involved in audited activities
Participate in periodic rotas including night and weekend shifts for emergency medical contact and unblinding phone requests as applicable
Provide risk assessment of clinical trials for local sponsorship as needed with support from senior medical leadership
Pharmacovigilance Support
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
Ensure client needs and concerns are addressed to maintain customer satisfaction
Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities to enhance satisfaction
Follow up sponsor satisfaction metrics pertaining to medical activities and execute remediation plans in coordination with line manager and Project Leader when needed
Business Development Support
Support business development while balancing time with billable tasks
Attend client phone conferences to communicate Parexel medical expertise and experience
Provide medical leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings
Attend preparation meetings and bid pursuit meetings as required
Provide support for marketing activities as requested
Share sponsor insights and experiences with peer and proposal teams
Medical Expertise
Provide medical expertise to clients across multiple channels and interactions, including medical review of documents that may be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel personnel as required
Write clear, concise medical documents
Participate in activities to promote Parexel medical expertise internally and externally (meetings, trainings, white papers, slide sets, publications)
Skills
Experience in clinical medicine with a specialty fellowship in a therapeutic area, kept up-to-date
Experience leading, mentoring, and managing a team (preferred, but not essential)
Background in clinical aspects of drug development, including medical monitoring and study design/execution
Good knowledge of the drug development process, including drug safety
Excellent interpersonal skills and the ability to interact well with sponsors and clients
Client-focused approach to work
Successful applicants will be
Medically qualified with completion of applicable clinical training (residency, internship, fellowship)
Board certified/eligible in Rheumatology with extensive clinical experience
Preferably with expertise in Lupus
Experienced as a physician in industry or as a clinical trial investigator with significant research experience
The ability to travel 15–20% is required.
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Overall responsibilities of the Associate / Medical Director are to:
Provide medical and safety monitoring for assigned projects
Provide medical expertise and leadership to support business development and pre-award activities
Supporting Activities
Medical Support / Medical Monitoring for projects and studies contracted to Parexel
Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor and the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP)
Participate actively in study planning with feasibility leaders and solution consultants
Participate in team project and investigator meetings
Provide training of study teams on indication and protocol (Note that this does not include direct medical advice on patient care or management)
Communicate with relevant sponsor counterparts on project challenges and accomplishments
Develop and review study documents such as clinical protocols, Medical Monitoring Plans (MMP), clinical and statistical summary reports, safety plans, informed consent forms, etc.
Deliver medical monitoring activities according to the MMP during study conduct
Answer site/study team questions relating to conduct or protocol
Review and sign off all data listings, protocol deviations, and datasets for medical accuracy and consistency
Provide medical leadership to the project in close coordination with the Project Leader, identifying risks and proposing actions to mitigate them
Attend and support audits or inspections pertaining to assigned studies even when not directly involved in audited activities
Participate in periodic rotas including night and weekend shifts for emergency medical contact and unblinding phone requests as applicable
Provide risk assessment of clinical trials for local sponsorship as needed with support from senior medical leadership
Pharmacovigilance Support
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
Ensure client needs and concerns are addressed to maintain customer satisfaction
Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities to enhance satisfaction
Follow up sponsor satisfaction metrics pertaining to medical activities and execute remediation plans in coordination with line manager and Project Leader when needed
Business Development Support
Support business development while balancing time with billable tasks
Attend client phone conferences to communicate Parexel medical expertise and experience
Provide medical leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings
Attend preparation meetings and bid pursuit meetings as required
Provide support for marketing activities as requested
Share sponsor insights and experiences with peer and proposal teams
Medical Expertise
Provide medical expertise to clients across multiple channels and interactions, including medical review of documents that may be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel personnel as required
Write clear, concise medical documents
Participate in activities to promote Parexel medical expertise internally and externally (meetings, trainings, white papers, slide sets, publications)
Skills
Experience in clinical medicine with a specialty fellowship in a therapeutic area, kept up-to-date
Experience leading, mentoring, and managing a team (preferred, but not essential)
Background in clinical aspects of drug development, including medical monitoring and study design/execution
Good knowledge of the drug development process, including drug safety
Excellent interpersonal skills and the ability to interact well with sponsors and clients
Client-focused approach to work
Successful applicants will be
Medically qualified with completion of applicable clinical training (residency, internship, fellowship)
Board certified/eligible in Rheumatology with extensive clinical experience
Preferably with expertise in Lupus
Experienced as a physician in industry or as a clinical trial investigator with significant research experience
The ability to travel 15–20% is required.
#J-18808-Ljbffr