The CAGT Medical Strategy Lead will provide senior 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. Some of the key areas of growth and innovation that the CAGT COE is focused on include groundbreaking strategies to optimize the execution of CAGT trials using data and patient-centered approaches, logistics management, and novel approaches to CAGT long term follow up studies.
- 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. Along with other key experts, responsible for leading teams in developing CAGT focused 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, identification of target site and principal investigator profiles, understanding the standard of care and competitive landscape, informing strategies for site and country selection and patient recruitment, and CAGT trial logistics including integration of the patient journey and IP manufacturing, shipping, storage, and management.
- 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.
- Stays current on industry pipeline and scientific and business landscape; does due diligence research of the CAGT landscape; educates and informs IQVIA clinical and business teams about cutting-edge CAGT developments
- Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities
Scientific and Research Qualifications and Experience
- A physician or senior scientist with experience in cell and gene therapy. 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 oncology, medical genetics, pediatrics, neurology, endocrinology, or cardiology. Highly qualified and experienced candidates with other terminal degrees such as a PhD or Pharm D will also be considered.
- At least 3 years clinical research relevant experience, including hands on operational delivery, regulatory, principal investigator, and/or drug development experience.
- Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT.
- Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
- Creativity in developing strategies to execute CAGT clinical trials in novel ways.
- 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
- Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)
- Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization
- Innovative and strategic thinker
- Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments
- Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required
- Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.
- Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
- Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it
- Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues