Real World Evidence Director, Cardio (80-100*)

Real World Evidence Director, Cardio (80-100*)

Job Description

Decades of untapped unmet needs in the Cardio-Renal-Metabolic (CRM) space are waiting for your footprint and guidance! As part of the long-term CRM strategic and operational growth plan, this is an ideal opportunity to bring new innovative products to those in need. We seek to become the leading innovators in the CRM space by developing a transformative Precision Medicine specialty portfolio for areas of high-unmet medical need. Our new Real World Evidence Director role based in Novartis’ Headquarter, in collaboration with a very diverse team, will provide, assess and bring life-saving drugs to patients globally!

Your responsibilities will include:
• To ensure a broad understanding of the value of RWE to the product value demonstration both globally and locally. Lead and ensure innovative, best-in-class evidence planning and creation, to maximize value of key development projects, products, and businesses in key geographies. Drives awareness on impactful use of secondary data across the franchise
• In priority disease areas defined by Franchise Medical and Patient Access heads, and focused on gaps, lead a cross-functional Real World Evidence team, embedded within a franchise and being a liaison to team members of the RWE team. With the clear objective to deliver and communicate scientifically valid and relevant RWE to proactively address the varying evidence requirements of stakeholders e.g. Medical Societies, HCPs, Payers (HTA, Regional, Local), Regulators, Patient Groups
• Utilize a decision matrix to determine with Medical Affairs / Patient Access / Safety / Product teams the most suitable source of RWD and RWE generation approach that meets prioritized evidence needs. Where secondary data is not available to generate fit-for-purpose evidence recommend the most appropriate prospective data collection study design and analysis that achieves the objectives
• To implement and ensure uniform excellence standards across franchises for development and reporting of RWE studies. Member of the Integrated Scientific Review Committee (ISRC) with key oversight and advisory responsibility related to post-approval activities (including e.g. global/local phase IV, non-interventional studies, and safety commitments). Chair Virtual Concept Review Forum (VCRF), a subcommittee of the ISRC, and guide country organizations on development of study concepts that are aligned with the franchise RWE strategy
• Lead innovation pilots that can support to overcome key challenges in drug development using RWD or enable to provide meaningful RWE in support of regulatory decision making (e.g. label changes, new indications). Responsible for applying innovative RWE study design and statistical analysis to address the key research questions for the product and the Franchise

Minimum requirements

What you’ll bring to the role:
• Advanced degree or equivalent education/degree in life science/healthcare required. MBA or equivalent preferred
• 8+ years of relevant pharmaceutical industry experience, academia, healthcare provider, payer, HTA, or relevant consultancy companies
• Deep understanding of Medical Affairs, Market Access/ HEOR, Safety or related disciplines to generate value evidence from retrospective and prospective studies. Very strong understanding of drug development and commercial disciplines, proven ability to identify key evidence needs for Commercial, Market access, Medical, Safety, Regulatory stakeholders and lead a team towards building the required insights
• Considerable experience in planning, creation, and analysis of real-world data, from both prospective and retrospective studies with a proven success record in this field Aim for five bullet points
• Considerable experience in collaborating with quantitative scientists and analysts

Desirable requirements:
• Cardio, Renal, Metabolic therapeutic area experience
• In country experience

*Some restrictions on flexible working options may apply and will be discussed during interview if applicable
Novartis Pharma AG
Market Access
Full Time