Supports compliance with protocol execution from a medical and scientific perspective Provides medical expertise during project delivery lifecycles; provides medical support to project teams and investigative sites; clarifies protocols and inclusion/exclusion determinations; advises around patient safety issues; performs medical reviews and clarifications of trial-related and post marketing studies Adverse Events; signal detection and aggregated reporting; and conducting project delivery lifecycles (premarketing and post marketing).
Expertise in medical monitoring:
Serves as Senior Medical Oversight for a program/study portfolio. May act as Global Medical Advisor on specific projects.
Serves as Scientific Advisor and provides guidance to Regional and Global Medical Advisors, Project Leaders and Customers on the medical and scientific aspects of assigned projects.
Serves as project team and customer escalation point for medically related matters of the project or program.
May provide expert medical guidance for protocol development.
Attends and presents at Investigator Meetings, as needed.
Attends Kick-Off meeting and client meetings, as needed.
Available 24 hours per day, 7 days per week to respond urgent protocol-related issues as the investigative sites.
Provides Line Management of a regional, multiregional or global staff.
Primarily serves as Global Therapeutic Head but may serve as Regional Head for assigned therapeutic area(s).
Leas de implementation of department mission, goals and objectives assigned staff. Contributes to the definition of policies, processes and standards operating procedures for the department and provides oversight for their implementation.
Manage staff in accordance with organizations policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance, mentoring and guiding professional development, rewarding and disciplining employees; addressing employee relations issues and resolving problems.
Supervises Medical Services and recommends course of action on management/human resources matters, including salary administration, transfers, hiring, terminations, training and professional development.
Continually reviews assigned staff workload and creates volume projections to ensure adequate resources are available to meet deliverables timelines and quality requirements.
Provides department strategic inputs for the resourcing process and outcomes, hiring targets and processes and onboarding and training standards.
May lead and develop managers to ensure staff develop and achieve goals and strategic departmental and corporate priorities.
Contributes to management level meetings within Medical Science.
Expertise in medical strategy:
Responsible for development of medically sounded delivery strategies for large, complex, multi-region studies for programs, including mega-studies and portfolio management, in partnership with sales and other functions responsible for business development activities.
Responsible for the development of medically related aspects of client proposals including the budget related to medical monitoring.
Provides medical and scientific advises to key internal stakeholders developing proposals. This may include, but is not limited to, providing strategic thinking to procol design/clinical development plan, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Actively supports sales in the preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys medical inputs and strategy. Attends and presents at costumer meeting or bid defense or partnership meetings, as required.
Participates in strategic business development activities including presentations to prospective clients and professional meetings.
Maintains awareness of industry development and may author related publications.
Contributes to pipeline analysis and supports due diligence research of select compounds and/or companies, as requested.
Qualifications -board-certified in oncology and/or hematology -experience in clinical trial conduct and medical monitoring -team management expertise
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