Medical Director - Cell & Gene Therapy

IQVIA•Durham, NC

1d•Remote

About The Position

The IQVIA Cell and Gene Therapy Center of Excellence (CAGT COE) is seeking a Medical Strategy Lead, a Board-Certified physician, to join their growing team. This role focuses on expanding the CAGT portfolio, with a particular emphasis on Gene Therapy/Gene Editing platforms, and advancing clinical development in this rapidly evolving area. The Medical Strategy Lead will act as a subject matter expert, leveraging clinical research and trial experience in CAGT, especially Gene Therapy/Gene Editing, to champion CAGT initiatives within IQVIA. The primary objective is to drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise, utilizing IQVIA's extensive data and clinical trial resources to create innovative, data-driven, and patient-centered solutions for CAGT trials. This role involves providing clinical and scientific expertise across IQVIA divisions, collaborating with indication-specific teams on integrated strategies for CAGT clinical trials, and engaging in early business development activities to guide sponsors. The Medical Strategy Lead will also be responsible for thought leadership through presentations, publications, and interactions with the medical scientific community.

Requirements

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.
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.

Nice To Haves

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.

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.