Senior Medical Director- Cell and Gene Therapy

divh2Senior Medical Director- Cell And Gene Therapy/h2pDurham, United States Of America | Full Time | Home-Based | R1531464/ppThe IQVIA Cell And Gene Therapy Center Of Excellence (CAGT COE), a hub of CAGT clinical innovation, is growing! We are looking for an exceptional board-certified physician to join our team as a medical strategy lead to help us expand our CAGT portfolio, with an emphasis on gene therapy/gene editing platforms, and advance this dynamic and rapidly expanding area of clinical development./ppThe CAGT medical strategy lead is a subject matter expert with experience in clinical research and clinical trials in CAGT and especially in the areas of gene therapy/gene editing, who will be a champion for CAGT across IQVIA. The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise. The CAGT medical strategy lead will be charged with using his/her clinical, scientific, and operational knowledge to harness the vast IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for CAGT trials./ppThe CAGT medical strategy lead will provide clinical and scientific expertise to all IQVIA divisions as requested and will collaborate closely with indication-specific teams to develop integrated strategies for CAGT clinical trials and studies. The CAGT medical strategy lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CAGT development. As a subject matter expert in CAGT, the CAGT medical strategy lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community./ppResponsibilities/pulliAccountable and responsible for creating innovative, evidence-based, and patient-centered delivery strategies and solutions for CAGT trials or studies, addressing the specific needs and challenges of each customer./liliIn partnership with indication-specific medical strategy, operations, sales, and other functions, responsible for award of strategic and tactical new business to achieve annual gross new business targets./liliResponsible for the inclusion of CAGT elements into proposals./liliProvide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, logistics challenges, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape./liliSupport 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 CAGT strategy./liliAttends and presents at customer meeting, or bid defense or partnership meetings, as required./liliParticipates in strategic business development activities including presentations to prospective clients and professional meetings./liliMaintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape./liliLeads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities./li/ulpQualifications/pulliA physician (MD or DO) or physician/scientist (MD/PhD) with experience in CAGT and especially in gene therapy/gene editing./liliA degree from an accredited and internationally recognized school is required./liliCertification in any medical sub-specialty will be considered and preference will be given to candidates with formal training in neurology, medical genetics, or cardiology./liliHighly qualified and experienced candidates with other terminal degrees such as a PhD or Pharm D will also be considered./liliAt least 5 years clinical research relevant experience, including hands on operational delivery and/or drug development experience in gene therapy/gene editing./liliRobust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT, especially in gene therapy/gene editing./liliExcellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility./liliIn depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. good clinical practice (GCP) and international conference on harmonization (ICH) guidelines./liliDemonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering./liliStrong clinical research skills and commitment to evidence-based and patient-centered clinical development./li/ul/div