Компания "Ventra"
Medical Team of our client, international pharmaceutical company, is in search of a team member, Data Generation and Scientific Communication Manager.
As a member of the Medical Team and contributor to the medical evidence generation community, the Data Generation & Scientific Communication Manager Eurasia builds on training and experience in health sciences and epidemiology research, public health, and regulations to ensure that relevant medical evidence is available and strategically used to contribute in the development, launch and commercialization of drugs throughout the entire product lifecycle, in the designated TA scope.
Main responsibilities:
Data generation:
- Be the local medical RWE expert and central connection with global RWE experts to ensure excellence in execution on brand RWE strategies, especially for pre-launch periods and launch brands, data strategies and RWE transformational initiatives.
- Develop and implement strategies for the identification, collection, evaluation, and analysis of real-world data (RWD) sources in the Eurasia /country, to contribute on various research initiatives and business objectives at Eurasia level, aligned with global brand and RWE strategies.
- Design and oversee observational studies, registries, and other real-world evidence-generating activities, including retrospective analysis of existing databases, ensuring compliance with regulatory requirements and ethical standards.
- Identify and evaluate local data gaps and opportunities in partnership with the global RW Data Strategy & Partnership Lead and Evidence Strategy Leads, that is fit-for-purpose to identified evidence gaps from brand IEGPs and the RWE data strategy.
- Manage relationships with external vendors, including contract research organizations (CROs), data providers, and academic institutions, to facilitate data acquisition, processing and analysis.
- Collaborate cross-functionally with internal stakeholders including clinical research units, medical affairs, market access, and commercial teams to identify research questions and generate evidence-based insights.
- Lead the analysis and interpretation of real-world data, employing advanced statistical methods and epidemiological techniques to derive meaningful insights, in collaboration with internal and external experts.
- Participating in external scientific engagement and maintaining at Eurasia level, to facilitate the collection of insights, challenges and best practices, as well as to deliver opportunities to shape the external acceptability of RWE.
- Prepare and present findings from real-world evidence studies to internal and external stakeholders, including scientific conferences, ministries of health, regulatory agencies, and healthcare providers.
- Lead the local upskilling of RWE with global initiatives, events and learning opportunities, coordinated with the global upskilling in RWE strategic initiative. Create and organize local activities to enhance learner motivation and deliver an effective learning experience.
- Stay abreast of developments in real-world evidence methodologies, advances in data science, regulatory guidance, and healthcare data trends, and integrate relevant insights into project planning and execution.
- Contribute to the development of real-world evidence strategies relevant to the Eurasia and integrated evidence generation plans to support product development, regulatory submissions, and market access efforts.
- Represent global RWE in country medical leadership team to facilitate seamless communication, coordinate, and alignment of RWE with medical strategies and changing business needs.
- Provide guidance and support to cross-functional teams on the use and interpretation of real-world evidence in decision-making processes.
- Drive the timely execution of the RWE operational plan
Scientific communication:
- Be the local scientific communication expert to ensure excellence in execution in Scientific communication strategy for related therapeutic areas and brands
Alignment/Leadership:
- Facilitate collaboration with internal and external stakeholders interacting with the country medical teams to achieve data generation and scientific communication goals.
Transversal projects
- Contribute or facilitate (as appropriate) the implementation at Eurasia /local level of the internal projects intended to simplify and optimize the medical transformation processes and resources.
About you:
Education:
- Advanced degree in life sciences, epidemiology, biostatistics, data science or equivalent discipline
- Post-graduate education in business or management is preferable
- Academic degree is preferable
- Minimum of 2 years in Real World Data (RWD) studies management
- Minimum of 2 years in coordination of cross-functional team(s)
- Expertise in data generation and scientific communication strategy building and execution
- Knowledge of development trends in pharmaceutical industry and principles of drug clinical study development; understanding of the goals and needs for Real World Evidence (RWE)
- Deep understanding of the regulatory/payer environment including legislation and reimbursement activities
- Proven experience in the field of clinical/epidemiology/public health with expertise in developing epidemiological studies
- Demonstrated experience in strategic evidence generation
- Significant peer reviewed publication track record in epidemiology, clinical and statistical and/or HEOR journals required
- Experience working in multiple therapeutic areas: transplant, type 1/2 diabetes or cardiovascular, Immunology, Rare Diseases and/or Hematology highly preferred.
- Fluent in English, written and oral communication