- 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.
- 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.
- 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.
- Persistence, resilience, and creativity seeking to work collaboratively.
- Ability to successfully collaborate within a matrix team, building consensus and encouraging diverse inputs.
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Director Evidence Generation - Munich, Deutschland - 582 GlaxoSmithKline GmbH & Co. KG
Beschreibung
Director Evidence Generation (m/w/d)
Are you interested in a highly visible medical affairs role that allows you to shape patient outcomes by leading medical evidence generation within a key market such as Germany across various therapeutic areas? If so, this position of Director Evidence Generation is an exciting opportunity to explore.
As Director Evidence Generation you are accountable for all medical affairs led evidence generation across Germany empowering teams to deliver meaningful evidence through establishment and application of methodological solutions and standards. This includes innovative / digital ways to data generation and analysis to build wholistic, meaningful and integrated evidence plans to thereby shape patient outcomes.
Key Responsibilities include, but are not limited to:
Why you?
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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