Vice President, Real World Evidence

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Vice President, Real World Evidence (RWE) strategically designs, develops and executes global real-world-data platform, and Epidemiology plans for the company's Gene therapies portfolio that are aligned with brand strategies, medical affairs strategies, clinical development plans, support product value propositions, and optimize market access. This role actively participates in cross-functional teams (Global, US) and is counted upon to provide strong scientific, clinical, and commercial strategic thinking.

Responsibilities

• Leads the entire Real World Data generation efforts across the company closely aligned and integrated within newly created Global Patient Access (GPA) function (comprising of Translational Access, Gene Pricing; Geneconmics) .
• Oversees RESTORE® the company's propriety SMA registry. Developing a vision for the next stage global scale-up to enroll and capture world-wide patients.
• Development of real world evidence for Novartis Gene Therapies (GTx) gene therapy platform (inline and pipeline assets) in collaboration with top countries and regions world-wide.
• Strategic advisor, communicating the right 'bundle' of Real-world Evidence services to meet world-wide stakeholder needs.
• Ensures ongoing availability of real world data to support regulatory health authority approval and global patient access to GTx gene therapies to demonstrate the ongoing value proposition of key assets.
• Partners with cross-functional stakeholders to ensure that RWE insights are used to support trial designs, commercial plans and post-marketing commitments.
• Works with Commercial Leadership and Marketing to develop and implement go-to-market strategies for RWE Services.
• Oversees and monitors effectiveness of global registries for Spinal Muscular Atrophy; Developing clear strategy of where we build; partner or acquire key data-bases to optimize global patient access.
• Develops the early construct for pipeline registries e.g. ALS, Rett's syndrome and Friedreich's ataxia and other multiple assets slated for the AAV9 gene therapy platform.
• Leads the set-up of additional global registries for pipeline therapy diseases.
• Leads and drives global registry governance activities (steering committee, publications committee).
• Oversee relationships with internal and external key stakeholders in support of e.g. design of key observational studies activities.
• Maintains awareness of external real world data landscape and company strategy to leverage, partner and optimize.
• Supervises and directs high-impact RWE initiatives (incl. observational studies, analyses of electronic health records (EHRs) and claims databases).
• Drives real-time evidence development to generate innovative treatment approaches.
• Provides strategic input to select appropriate digital health tools for patient-generated data in trials and real world studies.
• Supervises the development of internal and external publications.
• Promotes outstanding Thought Leadership and high visibility in the international biopharma community across all stakeholders for Real-world Evidence.
• Drives as a change agent that can not only understand patient access needs but can translate those needs into new delivery models for longer-term RWE growth.
• Attends 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.
• Provides guidance, mentorship, and training to all parts of the business involved in development and delivery of the Real-world Evidence services.
• Recruits, coaches and builds an inspired, curious high performing team.
• Drives the development of an active, agile and ambitious culture within GPA.
• Provide RWD input for due diligence of potential gene therapy targets for acquisition by Novartis Gene Therapies.
• Other related duties as assigned.

Qualifications

• Doctorate MD (preferred) degree with 8 years' relevant experience in observational/epidemiological (i.e., registries). Masters with 10 years relevant experience or bachelor of science (or similar degree) with 12 years observational/epidemiological (i.e., registries) or similar experience within access evidence generation function.
• Successfully held a role of similar capacity at another company.
• Demonstrated experience in real world data generation for highly specialized products.
• Strong commercial acumen and experience of working within integrated market access and HEOR; pricing functions.
• Ability to work across multiple functions, geographies and cultures and in a company with global functions in the U.S.
• Prior experience in rare diseases, in high-value products, and in a small, rapidly growing company are preferred.
• Strong written and verbal communication skills in English is required and proficiency in one of the major languages spoken in the region is preferred.

The level of this position will be based on the final candidate's qualifications.

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.

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