Chief Scientific Officer (m/f)
Heartbeat Labs – Venture Development
N1 is a new venture aiming to reinvent drug development through novel, tech-enabled clinical trial designs. We are driven by our mission to accelerate the clinical development of novel drugs and to facilitate patient access to urgently needed new treatments. Joining the N1 journey is a once-in-a-lifetime opportunity to make a global impact in clinical drug development.
The Chief Scientific Officer (m/f) will have a central role in the design, execution, analysis, and reporting phases of innovative clinical trial designs of our customers, and partner with our customers’ clinical development and study teams to accelerate their clinical development programs.
The right candidate is expected to work collaboratively with the N1 product, engineering, business, sales and project delivery colleagues to pioneer novel trial designs in the (bio)pharmaceutical industry. Furthermore, the Chief Scientific Officer (m/f) will contribute key insights on scientific challenges in drug development and so be a major force in shaping N1 and its offerings in order to accelerate drug development for leading (bio)pharmaceutical companies.
The Chief Scientific Officer (m/f) will analyze our customers’ key drug development challenges and promote novel study designs to help them reduce the time and cost of drug development:
- Bring innovative statistical thinking, methods and trial designs to be utilized in our customers’ clinical programs to drive enhanced drug development.
- Central to this approach is the systematic review of customers’ prior information, utilization of novel trials designs and statistical methods as appropriate, and statistical model building and simulation.
- Evangelize novel trial designs at stakeholders across the (bio)pharmaceutical industry, academia and political environments
- Collaborate with N1 project teams as well as with customers’ study teams in the design, analysis and reporting of innovative clinical trials
- Support external study teams that are performing statistical analysis of clinical data
- Perform statistical analyses of clinical data as necessary
- Support external study and/or project teams in the review and discussion of statistical analyses
- Frequently interact with regulatory bodies regarding accelerated clinical development options based on innovative trial designs.
- Use scientific expertise to shape both internal and external reports and presentations
- The qualified candidate has a Ph.D. in Statistics, Biostatistics, or related field, as well as a minimum of 8+ years experience in applying statistics in the (bio)pharmaceutical industry. Ideally, this experience would include exposure to the design and analysis of innovative clinical trial designs (e.g. real-world data approaches, adaptive trials or n-of-1 studies).
- ..has experience within a cross-disciplinary team environment, and have good leadership and managerial skills (5+ years of management experience)
- ..is experienced in computational simulation, analysis of (digital) biomarkers, SAS programming, and other relevant software applications, statistical methodologies and theories.
- ..has excellent statistical knowledge and the ability to apply it to scientific and clinical problems
- ..has excellent written and oral communication skills with the ability to influence widely and work collaboratively with customers and project teams.
- ..has a proven ability to manage multiple complex projects has collaborative and negotiation skills and demonstrate self-motivation.
- ..has a track record of influencing external environments through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated productivity in advancing novel scientific approaches and paradigms.
- ..has a record of professional service and familiarity with relevant emerging trends in the pharmaceutical industry has prior experience interacting with health authorities in the United States and/or the EU and with IND/BLA/NDA/MAA submissions
Expect an exciting, professional environment with responsibility and personal development. You get the chance to have a direct impact on several new business models. We are looking for great personalities with an entrepreneurial drive. Sounds interesting? We look forward to hearing from you!
Submit your CV along with your relevant working documents online.