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Medical Director - Rheumatology
PAREXEL International Corporation
Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Deborah – Senior Manager
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
Pawel – Senior Manager
Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Medical Director - Rheumatology
Bring your Rheumatology experience and Osteoarthritis expertise to an Industry Leader, Parexel!
This is a fantastic opportunity to join Parexel’s highly recognized Medical Sciences Team as we continue to grow our Global Immunology and Inflammation Therapeutic Franchise!
As a 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.
Overall responsibilities of the 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
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 (i.e.: tasks and time per task contracted) and according to the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP). Medical support include 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 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:
o Answer to site/ study team questions relating to the study conduct or protocol,
o 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 either GLP or RLP by
o Timely identifying risks and challenges,
o Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation.
o 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/ Global Head of TA (as appropriate)
• 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
Pharmacovigilance Responsibilities continued:
• Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction
• Follow up sponsor 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
• Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity 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
• Provide medical expertise to client as contracted across multiple channels and interactions such as:
o Consultancy on protocol development, drug development program etc.
o Medical review of various documents which might be audited by clients and regulatory agencies
o More generally in any client interactions
• Provide medical expertise and training to other Parexel personnel, as required.
• 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, trainings, white papers, slide sets, publications etc.
• Experience in clinical medicine (general or specialist qualifications) with a specialty 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
• 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
• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
• Excellent time management skills
• Client-focused approach to work
Successful applicants will be:
• 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 Osteoarthritis, SLE, vasculitis and gout is preferred
•Experience as a Physician in Industry or as a clinical trial investigator is a plus.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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