Director, Global Real-World Evidence (RWE) Operations
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
Director, Global Real-World Evidence (RWE) Operations
Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. bluebird bio’s growing Real-World Evidence (RWE) team is on the front line of evidence generation to support the development of gene therapies across multiple therapeutic areas. This is not a typical real-world evidence operations role – come make your mark with us!
Reporting to our Global Head of RWE you will be responsible for all aspects of global operations for bluebird’s RWE team. You’ll ensure the ongoing availability of best in class real-world data to support health authority approvals and global patient access to gene therapies to demonstrate the ongoing value proposition of bluebird’s portfolio of transformative therapies in severe genetic diseases and cancer.
One of your primary areas of work will be to ensure the operational integrity of bluebird sponsored global registries for beta thalassemia, sickle cell disease and adrenoleukodystrophy. You’ll oversee the development and implementation of solutions used for real-world data collection and all contract research organizations with whom we partner for data generation and management services. You will lead an awesome team of RWE operations experts and provide guidance, mentorship, and training on RWE operations to all parts of the bluebird bio organization involved in development and delivery of RWE.
You will be an active participant on our cross-functional project teams and in data collaborations with research partners and be responsible for the generation of complete, accurate, high quality, regulatory-compliant data collected in support of publications and regulatory and HTA organization submissions.
You must be familiar with all applicable external regulatory requirements, bluebird bio’s internal standard operating procedures (SOPs), and accepted industry best practices, yet able to go beyond the traditional to find innovative and creative solutions to operate real-world data collection activities at a class-leading level.
About the role:
- Lead all aspects of global operations of bluebird bio’s growing portfolio of real-world evidence studies
- Oversee building a capability that becomes a source of sustained competitive advantage for bluebird bio in identifying, acquiring, integrating and mining diverse real-world data from multiple geographic and healthcare system sources to support evidence generation and real-world studies
- Provide operational leadership to high-impact RWE initiatives (incl. observational studies, IIS, and Ph-IV studies)
- Lead a team of RWE operations birds with responsibility for RWE study operations and data management
- Participate in cross-functional forums to ensure that RWE operations align with trial designs, commercial plans, and post-marketing commitments
- Evaluate and assess strengths and weaknesses of external real-world data sources, and potential partners for advancing the data strategy across bluebird bio’s therapeutic areas of interest
- Provide support for strategic decisions on bluebird bio evidence and observational research external collaborations in the US and other markets
- Ensure compliance with internal SOPs and processes, working across functional areas to approvals on contracts, protocol amendments, and study documents, as necessary
- Provide strategic input to select appropriate digital health tools for patient-generated data in trials and real-world studies
- Participate in global registry governance activities (steering committee, publications committee)
- Actively lead and participate in cross-functional RWE teams that include project management, biostatistics, programming, medical, regulatory, market access and marketing
- Select and provide oversight of third-party vendors and data management contract research organizations (CROs) as needed; establish strong relationships with CROs to enable optimal outcomes
- Drive relationships with internal and external stakeholders in support of the design of key non-interventional study activities
- Ensure compliance with global RWE regulatory requirements and quality standards
- Some domestic and international travel required
- An advanced degree (masters or similar) in a health professional or scientific discipline. A doctorate or similar degree (MD, PharmD, PhD) is preferred
- A minimum of 10 years’ experience in healthcare sector, preferably in RWE, epidemiology, HEOR, digital solutions, population health or related functions/fields is required with increasing levels of responsibility and leadership
- Registration (BLA/NDA/MAA) submission experience highly desired
- Must be process and detail oriented while demonstrating the ability to handle multiple projects simultaneously and execute with a sense of urgency to achieve business results
- Experience managing multiple complex global studies; experience with RWE and data integration is preferred
- Prior experience in rare diseases, in high-value products, and in a rapidly growing company are preferred
- Ability to work across multiple functions, geographies and cultures and in a company with global functions in the U.S.
- A genuine care for patients and a desire to make a meaningful difference in their lives
- Be collaborative, flexible, creative, and able to work in a fast-paced environment
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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