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Director, Global Real-World Evidence (RWE) Operations

Company: bluebird bio
Location: Cambridge
Posted on: February 20, 2021

Job Description:

Director, Global Real-World Evidence (RWE) Operations 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 About you: --
    • 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-- Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
      Point of Data Transfer - GDPR --*
      Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent --located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located--here .Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information. U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: bluebird bio, Cambridge , Director, Global Real-World Evidence (RWE) Operations, Executive , Cambridge, Massachusetts

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