Boston, MA, US.
The Director, R&D Quality, Real World Evidence (RWE) provides leadership in assuring appropriate quality/compliance oversight of Vertex’s medical affairs and RWE-related processes, initiatives, and systems. The role will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs in non-interventional evidence generation.
The Director, R&D Quality, RWE will actively partner across R&D Quality, Biometrics, RWE, HEOR and Medical Affairs and act as a catalyst for continuous improvement. This role will ensure processes, initiatives, and systems account for evolving R&D-related regulations, guidance and inspection trends and maintain currency with external best practices, as appropriate.
The Director, R&D Quality, RWE will ensure communication and visibility of meaningful indicators of process health to permit ongoing identification of operational risks in RWE and medical affairs processes that will require action. This individual will ensure delivery of both portfolio and program-level views of clinical process and quality system risk and performance to relevant stakeholders across R&D Quality and the business.
The Director, R&D Quality, RWE will report to the Senior Director, R&D Quality, and will work closely with other R&D Quality members to drive risk-informed, phase-appropriate processes for data quality and integrity and consistency in execution in RWE studies and other non-interventional data generation activities.
Broad responsibilities include:
Operations Management: Oversees and ensures effectiveness of processes related to RWE and other non-interventional studies and ongoing inspection readiness
Alignment: Engages the organization through direct line-of-sight of their work to Vertex’s vision 2030 and cross-QA operational performance in delivery of strategic and business goals/objectives
Execution: Actively champions and technically guides quality and relevant business areas to drive real-time inspection readiness in core study related processes and activities
Relationship Management: Fosters ongoing relationship dynamics cross-functionally while driving progressive improvements as Vertex continues to transform to the vision 2030 model
Role Modelling: Consistently demonstrates an ongoing commitment to achievement of Vertex and QA goals, as well as the success of all team members consistent with the Vertex phenotype
Specific responsibilities include.
- Partners closely with Biometrics, Real World Evidence Research, Global Medical Affairs, Health Economics and Outcomes Research (HEOR) and other internal stakeholders in Quality to ensure appropriate oversight and evolution of Vertex’s processes and systems related to RWE and non-interventional study design, conduct, execution, archiving, analysis, and reporting
- Provides expertise and consultative guidance on business initiatives involving processes, procedures, regulations, and tools intended for use in RWE/non-interventional activities.
- Identifies and anticipates potential compliance issues that may impact the ability to meet business goals; develops and implements methods of improvement and resolution in a pragmatic and effective manner.
- Maintains ongoing inspection readiness, including conducting periodic spot checks of process adherence and documentation.
- Serves in an advisory/ consultative role in development of audit strategy for RWE-related processes.
- Partners with internal business and quality stakeholder to define and establish risk-informed data quality control activities and quality metrics (e.g. KQIs) across non-interventional studies.
- Ensures timely and effective communication of summary trending and other insights on the quality of delivery in non-interventional/RWE studies to relevant business and quality partners and in relevant forums.
- Supports the delivery of operational governance meetings (e.g. QLT).
- Maintains current awareness of global regulatory requirements and monitors for changes in regulatory interpretation relevant to Vertex’s RWE activities.
- Leads or participates in strategic initiatives to improve compliance to regulatory requirements and standards related to clinical trial conduct.
- Actively participates in external initiatives and industry forums related to RWE/non-interventional studies and translates insights to R&D Quality and its business partners.
- Participates in Due Diligence and integration activities as appropriate.
- Proactively review and amend quality framework for RWE-R, RW-Operations and HEOR as deemed appropriate.
Required Knowledge, Skills, And Competencies
Key Leadership Skills:
- Learn, Teach, Develop
- Lead by example
- Foster exemptional collaboration
- Drive breakthrough results
- Promote enterprise thinking
Key Technical Knowledge, Skills and Competencies:
- Broad and deep global health regulatory agency knowledge and practical experience interpreting and applying regulations related to relevant research and development areas, including, but not limited to, GCP and GPP.
- Current knowledge of industry trends and best practices for efficiency, compliance and effectiveness related to real world/non-interventional/observational study design(s) and delivery, with a focus on best practices in study design, execution, data collection and curation, quality control, retention, and analysis.
- Demonstrated strategic planning, communication and execution skills required.
- Creative and innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness.
- Ability to integrate and apply in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality, Excellence and Partnership.
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
- Comfortability working and progressing strategic goals in an undefined/growing environment.
- Proven ability to influence varying levels of executive leadership to challenge the status quo for progressive improvements.
- Proven track of working collaboratively as a quality partner with study and phase specific teams
- Ability to work independently and apply critical decision-making skills in time sensitive situations.
Education And Experience:
- B.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background.
- Experience working in regulated and unregulated RWE and HEOR space
- Professional association membership and participation preferred, not required (for example: RAPS, DIA, SQA, RQA).
Salary Range $176,000 – $264,000 annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition.
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