Whippany, NJ, US.
Evidence Generation, RWD/RWE & Behavioral Science has the objective to improve the health and consumer well-being through generating innovative and impactful evidence that is one of the foundations of our self-care business. The RWE Lead is responsible to deliver RWE strategies, initiatives and studies including leveraging complex, clinically rich, patient-level healthcare data to answer specific research questions supporting the Bayer Consumer Health (BCH) business by innovative, RWE strategies that will pioneer the use of RWE within self-care, and designing fit-for-purpose non-interventional/observational initiatives to directly address BCH specific research questions across all Bayer Consumer health (BCH) categories and brands. RWE Lead establishes and leads cross-functional RWE core team serving Medical category organization in their portfolio including post marketed as well as pipeline assets.
The RWE Lead will lead a cross functional team for the development of integrated evidence generation plans across the entire product life cycle with the mandate serving research, development, regulatory, medical, and commercial strategies and needs. The aim of the RWE plan is to enhance the preclinical evidence/relevance to human diseases, speed up indication finding, support innovative trial design, ensure the benefit / risk profile, support critical market access and a stronger competitive position/differentiation in the market. The RWE plan will be guided by the brand plans.
The RWE Lead serves as an expert with deep knowledge of non-interventional/observational research and RWE generation using advanced and innovative statistical methods and tools for advanced data visualization. The RWE lead serves as a point of contact for diverse stakeholders within Bayer CH with an interest in or need for evidence generation for the Megabrands / Multiregional brand as strategically need it.
Your Tasks And Responsibilities
The primary responsibilities of this role, Sr Associate Director Real World Evidence Lead, are to:
- Responsible and accountable for the RWE plans across all categories, brands, and products on a global, and local level by developing innovative and pioneering RWE strategies, approaches, and studies. In this role the incumbent leads creative approaches to problem solving and development of new RWE deliverables and is responsible as well as accountable for end-to-end manage from strategic planning through to conduct, reporting and data presentation;
- Collaborate with Evidence Generation Head, Medical Experts and Evidence Generation representatives to support and ensure the flexible coordination of activities and resources across the wider Medical Affairs and Evidence Generation team;
- RWE Lead is responsible to lead and develop Integrated RWE Generation Plan according to the strategic brand plan, addressing critical business and technical questions/challenges across the entire product life cycle and covering diverse needs of consumers/patients, physicians and regulators;
- Provide high quality expertise and guidance regarding data sources (e.g., identification, governance, and onboarding), standards, use of advanced and innovative methods and tools for RWE generation, analyzation, and visualization;
- Guide the prioritization of research questions (in collaboration with Medical experts where appropriate) and translation of needs of business stakeholders into portfolio of analytics projects and manage strategic initiatives incorporating the most innovative methodological approach and appropriate data sources, tools, and platforms.
- Responsibility and accountability for establishing a pool of data sources and RWE standards;
- Lead collaborations with internal, external stakeholders and vendors to identify, evaluate and develop innovations to meet internal medical/scientific/business needs. As part of this the incumbent is responsible and accountable for the vendor strategy establishing and overseeing a pool of RWE vendors which enable BCH to pioneer the use of RWE within self-care;
- Lead the development of RWE standards, tools, templates, as well as best practices, and engage with external academic and commercial analytics ecosystem stay abreast of latest technical developments in the RWE, epidemiological and data science fields;
- Oversee and ensure compliance with company standards and processes to ensure the initiatives are audit-ready, including keeping tracking systems up-to-date and accurate;
- Responsible and accountable for all study documents (e.g., Protocols, Statistical Analysis Plan, Reports, publications, presentations).
Who You Are
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
- Education: Advance degree in Medicine, pharmacy, Life science disciplines and/or postgraduate qualification e.g., PhD (min master’s degree) in Epidemiology, biostatistics, micro-econometrics, bioinformatics, data science, health economics or other related disciplines;
- Competencies: Strong leadership capabilities combined with a strong business insight, a strategic mindset and innovative thinking;
- Prior work experience of RWE execution in a pharmaceutical company or contract research organization. Being highly skilled in using data from big data sources and a proven ability to interpret, discuss and represent RWE;
- Excellent project management and organization skills within a global/matrix environment ensuring delivery to target and expectations;
- Good understanding in how to drive outcomes to meet customer needs, and how to overcome challenges to meet the high expectations;
- Track record of successfully evaluating strategic options with a clear sense of value-creation leveraging real world data or evidence;
- Extensive experience translating strategy into actionable projects and initiatives;
- Thorough understanding of heterogeneous customer needs including Medical scientific fora, Regulatory Authorities, Health Technology Assessment bodies and major national payers;
- Thorough understanding of a broad range of methodological approaches, data sources and analytical tools for designing, implementing, analyzing and reporting of projects;
- Strong strategic, envisioning and critical thinking skills, with the ability to think/act both strategically and tactically;
- Proven leadership and management skills in a matrix organization;
- Highly result-oriented while tackling complex strategic and analytical problems;
- Excellent knowledge in English combined with high ethical values and standards as well as strong verbal communication/presentation skills.
Preferred Qualifications:
- Experience: Substantial experience (at least 10+ years) in clinical research (either in pharmaceutical industry, CRO or academic institute) ideally in a global setting;
- At least 6 years’ experience in a leading role with an in-depth knowledge of RWE as well as a successful RWE publications (peer reviewed publications) record.
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
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