Senior Medical Director- Cell and Gene Therapy

About the role

The 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.

Responsibilities

• Accountable 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.
• In 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.
• Responsible for the inclusion of CAGT elements into proposals.
• Provide 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.
• Support 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.
• Attends and presents at customer 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 pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape.
• Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities.

Qualifications

• A physician (MD or DO) or physician/scientist (MD/PhD) with experience in CAGT and especially in gene therapy/gene editing.
• A degree from an accredited and internationally recognized school is required.
• Certification in any medical sub-specialty will be considered and preference will be given to candidates with formal training in Neurology, Medical Genetics, or Cardiology.
• Highly qualified and experienced candidates with other terminal degrees such as a PhD or Pharm D will also be considered.
• At least 5 years clinical research relevant experience, including hands on operational delivery and/or drug development experience in gene therapy/gene editing.
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT, especially in gene therapy/gene editing.
• Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
• In 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.
• Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering.
• Strong clinical research skills and commitment to evidence-based and patient-centered clinical development.