Director, Global Real-World Evidence
Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
The Director Real-World Evidence (RWE) will be responsible for the execution of a regional portfolio of RWE initiatives and the operational leadership of the Novartis Gene Therapies (GTx) SMA Disease registry. Responsibilities include strategic registry deployment and the management of efficient and compliant processes in support of registry operations.
The Director will lead registry operations in assigned region (Americas, EMEA, APAC) and manage vendor and stakeholder interactions. This role is expected to partner with Early Development, Clinical R&D Commercial/Marketing/Market Access, and Medical Affairs colleagues regarding the further development of registries and observational research initiatives to support development and commercialization of GTx products.
- Directs high-impact RWE initiatives (incl. observational studies, analyses of electronic health records (EHRs) and claims databases).
- Responsible for the deployment, day-to-day operations, resourcing, and support of the GTx SMA Registry.
- Independently manages relationships with internal and external key stakeholders in support of observational studies activities.
- Anticipates and solves operational challenges independently and escalates issues for resolution.
- Drives internal and external publications including abstracts and manuscripts.
- Supports and participates in registry governance activities (steering committee, publications committee) and develops and implements global policies to improve the quality and efficiency of registry data; participates in the development and maintenance of relevant SOPs and Working Instructions.
- Partners with investigators and develops site guidelines for formulary evaluations.
- Leverages RWE to support regulatory requirements, addresses payer evidence generation and assist with reimbursement activities.
- Solves complex technical problems and partnership/clientele issues related to registry data generation with advanced experience and expertise.
- Attend medical/scientific, pharmacy, and other professional meetings to keep up with changing trends and remain current within the field relating to new research and medical trends affecting each product area.
- Responsible for routine data management and advances GTx RWE initiatives including regular performance reporting on data.
- Manages and conducts data integrity audits either through external vendors and consultants or internal staff, develops and implements related departmental policies and procedures and provides guidance in the proper use of registry data and data sharing.
- Works with the cross-functional representatives for each study to ensure that the database captures all critical data.
- Possesses excellent communication and interpersonal skills especially over departmental and geographical boundaries.
- BS, MS, required.
- PhD, PharmD, MD or DO highly desirable.
- Minimum 7 years of observational/epidemiological (i.e., registries) experience.
- Management and health informatics experience is preferred.
- Possesses excellent observational and epidemiological research experience.
- Experience working in a global organization highly desirable.
- Experience working in a matrixed environment highly desirable.
The level of this position will be based on the final candidate's qualifications.
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.