Overview
AbbVie is committed to being an industry leader in accelerating the transformation of molecules to medicines to maximize the value for patients and AbbVie. To do so, we must have a clear strategy Ensure clinical trial populations reflect the global and varied real-world populations living with the disease. The Patient Access Associate Director sits within Patient Inclusion in the Clinical Development Operations (CDO) organization and is responsible for supporting the strategic and tactical implementation of AbbVie's enterprise-wide plan to improve clinical trial inclusion. With this role, you will be an important member of the team that will be driving change in the internal culture, behaviors, and ways of working to strengthen our understanding of disease disparities and the effects on global clinical trial populations. You will directly work collaboratively to ensure a consistent way of working across the portfolio with internal and external stakeholders.
Responsibilities
* Align with the Director to enhance the roadmap and develop the action plan to implement AbbVie's Patient Inclusion strategy across the portfolio
* Collaborate with cross-functional partners to identify process improvements to disease area strategies and clinical trial lifecycle to increase representative patient participation
* Partner with regionally aligned counterparts in Patient Inclusion to develop a strategy to scale current patient inclusion framework to indication level plans that incorporate global considerations
* Identify relevant data sources that synthesize clinical, epidemiological, and real-world evidence on disease prevalence, incidence, burden, and health disparities and extract meaningful data to support global patient access strategies.
* Work in-region to support global expansion of Patient Inclusion capabilities and processes
* Influence leaders to champion internal behaviors to strengthen our understanding of disease disparities and the effects of representative populations
* Work with key stakeholders to develop TA/indication level strategies to increase representation in clinical trials
* Maximize external engagement by leveraging existing relationships and exploring new opportunities to collaborate with community partners, patient advocate organizations, institutions, and key Health Care Practitioners to broaden knowledge about clinical research in underrepresented communities and support the patient care journey.
* Reinforce alignment between the Patient Inclusion principles and AbbVie's business strategy
* Monitor impact of Patient Inclusion strategies based on analytics to demonstrate improvement in trial representation
Qualifications
* Bachelor's Degree in a scientific field required, Advanced degree is desirable.
* Minimum of 8 years + of pharma-related/clinical research experience or equivalent
* 6+ years of patient recruitment, project management and people management (preferred)
* Advanced working knowledge of ICH and GCP guidelines required.
* Operational understanding of the global regulatory environment is desirable.
* Strong proficiency in authoring and reviewing scientific, medical, and regulatory documents to ensure consistency and strategic alignment with global submissions
* Skilled in managing the end-to-end development of regulatory-ready submission documents
* Excellent collaborator and articulate communicator – easily builds relationships across geographic locations and gains cross functional alignment.
* Strategic thinker with understanding of clinical development process and uses data to drive the business and continuous improvements.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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