Associate Director Rwe
2 days ago
Associate Director RWE Oncology Join one of the fastest evolving biotech companies right now.
Your new company
My client is one of a market leading biopharmaceutical company that is focused on advancing medicines to prevent and treat diseases. The Company's portfolio of products and pipeline of investigational drugs includes treatments for HIV, COVID-19, hematologyoncology cell therapy and other. The Company operates across the globe and is highly recognised for how it's changed patients lives everyday.
Your new role
- Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development and post-authorization evidence requirements for one or more pipeline/lifecycle indicationsfor products in Franchise(s) in Oncology.
- Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.
- Generate, within time, budget, and quality standards, real-world evidence including, but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarkingof clinical outcomes, comparative safety and effectiveness research, and post-authorization studies.
- Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.
- Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
- Contribute to the communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers.
- Contribute to timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide
- Represent the RWE function in internal cross-functional teams and initiatives.
- Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators,payers, providers, and patients.
- Identify the need for and contribute directly to the development of processes and delivery of training aimed at increasing the efficiency, quality, and impact of functional activities.
- Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge.
What you'll need to succeed
- Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master's degree in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 2 years (PhD) or 8 years (MS) of relevant experience.
- Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
- Experience with secondary data analysis, including electronic medical record and/or medical claims databases, and with statistical analysis tools, such as SAS and R.
- A track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
- Knowledge of the Oncology therapeutic area.
- Experience leading studies and projects in a matrix setting.
- Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.
- Ability to manage priorities, resources, and performance targets.
What you'll get in return
This company is offering a competitive salary package and flexible working options as well as long term incentives.
What you need to do now
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
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