Parexel
Associate / Medical Director - Rheumatology (home-based, US)
Parexel, Virginia, Minnesota, United States, 55792
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.
As an Associate / Medical Director, you will work closely with some of the best and brightest in the industry and assist our clients in the journey of getting new and innovative drug treatments into the hands of those who need them most. You will be a member of a fantastic and cohesive global team with great mentors and work with small to large clients across a broad spectrum of diseases.
Responsibilities
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 according to the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP). Medical support includes but is not limited to the following:
Participate actively in study planning with feasibility leaders, solution consultants
Participate in team project and investigator meetings
Provide training of study teams on therapeutic indication and protocol (this does not include 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 other Parexel departments
Deliver medical monitoring activities according to MMP during the study conduct
Answer 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 according to the role assigned (GLP or RLP):
Timely identify risks and challenges
Proactively propose and/or deliver relevant actions contributing to the success of the study/project and risk mitigation
Create 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 support of the designated Senior Medical Director/Global Head of Therapeutic Area (as appropriate)
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 ensure customer satisfaction
Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities to enhance client satisfaction
Follow up sponsor satisfaction metrics pertaining to medical activities in assigned studies and propose/excute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction
Business Development Support
Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity with billable tasks
Meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or indication
Provide medical expertise/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 (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 medical review of various documents which might be audited by clients and regulatory agencies
Other Client Interactions
Provide medical expertise and training to other Parexel personnel, as required
Write clear, concise medical documents as appropriate
Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally, including but not limited to internal therapeutic area meetings, trainings, white papers, slide sets, publications, etc.
Skills
Experience in clinical medicine (general or specialist qualifications) with a specialty Fellowship in a therapeutic area which is expected to be kept up-to-date
Experience leading, mentoring and managing individuals/ a team, preferred but not essential
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
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
Client-focused approach to work
Qualifications
Medically qualified in an acknowledged medical school with completion of applicable clinical training (residency, internship, fellowship)
Board certified/Board eligible in Rheumatology with extensive clinical experience
Expertise in Lupus is preferred
Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience
Travel required: 15-20%.
Seniority Level Director
Employment Type Full-time
Job Function Health Care Provider and Consulting
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
Richmond, VA - $120,000.00-$150,000.00
#J-18808-Ljbffr
As an Associate / Medical Director, you will work closely with some of the best and brightest in the industry and assist our clients in the journey of getting new and innovative drug treatments into the hands of those who need them most. You will be a member of a fantastic and cohesive global team with great mentors and work with small to large clients across a broad spectrum of diseases.
Responsibilities
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 according to the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP). Medical support includes but is not limited to the following:
Participate actively in study planning with feasibility leaders, solution consultants
Participate in team project and investigator meetings
Provide training of study teams on therapeutic indication and protocol (this does not include 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 other Parexel departments
Deliver medical monitoring activities according to MMP during the study conduct
Answer 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 according to the role assigned (GLP or RLP):
Timely identify risks and challenges
Proactively propose and/or deliver relevant actions contributing to the success of the study/project and risk mitigation
Create 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 support of the designated Senior Medical Director/Global Head of Therapeutic Area (as appropriate)
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 ensure customer satisfaction
Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities to enhance client satisfaction
Follow up sponsor satisfaction metrics pertaining to medical activities in assigned studies and propose/excute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction
Business Development Support
Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity with billable tasks
Meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or indication
Provide medical expertise/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 (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 medical review of various documents which might be audited by clients and regulatory agencies
Other Client Interactions
Provide medical expertise and training to other Parexel personnel, as required
Write clear, concise medical documents as appropriate
Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally, including but not limited to internal therapeutic area meetings, trainings, white papers, slide sets, publications, etc.
Skills
Experience in clinical medicine (general or specialist qualifications) with a specialty Fellowship in a therapeutic area which is expected to be kept up-to-date
Experience leading, mentoring and managing individuals/ a team, preferred but not essential
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
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
Client-focused approach to work
Qualifications
Medically qualified in an acknowledged medical school with completion of applicable clinical training (residency, internship, fellowship)
Board certified/Board eligible in Rheumatology with extensive clinical experience
Expertise in Lupus is preferred
Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience
Travel required: 15-20%.
Seniority Level Director
Employment Type Full-time
Job Function Health Care Provider and Consulting
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
Richmond, VA - $120,000.00-$150,000.00
#J-18808-Ljbffr