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Head of Evidence Generation (m/w/d) Medical Affairs (DE)
[5993]
Our client is one of THE leading pharmaceutical companies on this planet. The organisation drives innovation by it's very own global set-up in research & development and brings life saving therapies to the market on a constant basis. Our client seeks to empower internal teams across Germany to deliver meaningful evidence through establishment and application of methodological solutions and standards our. This includes innovative / digital ways to data generation and analysis to build wholistic, meaningful and integrated evidence plans to thereby shape patient outcomes. If this is what you are aiming for in your next career step we are delighted to talk to you about the position of the Director Evidence Generation (m/f/d) Medical Affairs Your tasks ·Advise and oversee the medical affairs led evidence generation for the German organization including the design of real-world evidence (RWE) studies (e.g., non-interventional, observational, data base studies, systematic literature) to address research questions across the portfolio and in close collaboration with the respective Therapeutic Area Head/ Medical Affairs Lead ·Advise and oversee the preparation of study documents, including protocol, statistical analysis plan and report ·Oversee or lead the management and analysis of real-world datasets to derive clinically meaningful outputs ·Oversee or lead the development of novel methodological approaches in evidence generation ·Oversee and lead the “Medical Unmet Need” department while providing strategic sparring and methodological advice to data mining / analysis and vendor selection ·Ensure all research is executed and documented according to good clinical practice and highest industry standards as well as local governance requirements ·Be an active member of the German medical leadership team and drive clear accountabilities and execution in line with the company culture within and beyond dedicated areas of focus Your qualifications ·University degree of M.D/PhD or equivalent in epidemiology, biostatistics, or related field with 4+ years professional experience in a pharmaceutical/biotech, CRO, healthcare, academic or research setting. ·4+ years of demonstrated hands on experience in real world evidence study design and/or analysis (including statistical analysis) with deep understanding on how to work with real world data and assess quality and reliability ·Proven leadership track record (direct and indirect; 3+ years) ·Proven understanding of the German regulatory, data governance, HTA and payer environments ·Strong experience and track record of developing and delivering evidence plans and non-interventional study designs ·Self-initiated, self-motivated with strong communication skills and willing to take accountability, contribute own ideas and give decisive impulses to teams on national, regional, and global level. ·Ability to successfully collaborate within a matrix team, building consensus and encouraging diverse inputs ·Persistence, resilience, and creativity seeking to work collaboratively. ·Strong written and verbal communication, motivational and interpersonal skills, and high degree of fluency in English and German, both written and spoken. · Track record of successful project management (including budget management) ·Proven skills in driving a vision, setting ambitious objectives, and tracking progress of key outcomes If you feel attracted by this job feel free to get in touch with Tilman Grumbd at Optares Medical via tilman.grumbd@optares.de or by phone under +49 441 21879-34
- Advise and oversee the medical affairs led evidence generation for the German organization including the design of real-world evidence (RWE) studies (e.g., non-interventional, observational, data base studies, systematic literature) to address research questions across the portfolio and in close collaboration with the respective Therapeutic Area Head/ Medical Affairs Lead
- Advise and oversee the preparation of study documents, including protocol, statistical analysis plan and report
- Oversee or lead the management and analysis of real-world datasets to derive clinically meaningful outputs
- Oversee or lead the development of novel methodological approaches in evidence generation
- Oversee and lead the “Medical Unmet Need” department while providing strategic sparring and methodological advice to data mining / analysis and vendor selection
- Ensure all research is executed and documented according to good clinical practice and highest industry standards as well as local governance requirements
- Be an active member of the German medical leadership team and drive clear accountabilities and execution in line with the company culture within and beyond dedicated areas of focus
Your qualifications
- University degree of M.D/PhD or equivalent in epidemiology, biostatistics, or related field with 4+ years professional experience in a pharmaceutical/biotech, CRO, healthcare, academic or research setting.
- 4+ years of demonstrated hands on experience in real world evidence study design and/or analysis (including statistical analysis) with deep understanding on how to work with real world data and assess quality and reliability
- Proven leadership track record (direct and indirect; 3+ years)
- Proven understanding of the German regulatory, data governance, HTA and payer environments
- Strong experience and track record of developing and delivering evidence plans and non-interventional study designs
- Self-initiated, self-motivated with strong communication skills and willing to take accountability, contribute own ideas and give decisive impulses to teams on national, regional, and global level.
- Ability to successfully collaborate within a matrix team, building consensus and encouraging diverse inputs
- Persistence, resilience, and creativity seeking to work collaboratively.
- Strong written and verbal communication, motivational and interpersonal skills, and high degree of fluency in English and German, both written and spoken.
- Track record of successful project management (including budget management)
- Proven skills in driving a vision, setting ambitious objectives, and tracking progress of key outcomes
