AbbVie

Associate Director, Evidence Generation

Employer
AbbVie
Location
Sunnyvale, CA, United States
Posted
Oct 26, 2020
Ref
2004479
Required Education
Masters Degree/MBA
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Associate Director, Health Economics & Outcomes Research/Real World Evidence (HECOR/RWE), Medical Affairs provides operational and scientific leadership for the real-world CLL disease registry activities, inclusive of engagements with cross-functional teams, partnered alliance registry research initiatives, and collaboration with the external steering committee. Leadership entails: oversight of the Registry Annual Publication Plan consistent with the wider evidence generation strategy, ensuring appropriate cross-functional resource allocation for such plan, operational and scientific oversight of the plan with efficient and timely implementation, and adherence to compliance considerations wherever relevant. The position may scientifically lead personnel and the team responsible for the management of registry activities and is responsible for the complex cross functional integration necessary for a successful registry.

Key Responsibilities include:

  • Partner with the disease registry working group and study management team (SMT) in the development of the registry's overall Annual Research Plan as the operational contributor.
  • Work closely with internal stakeholders and across the alliance to understand overall medical strategies and build registry research plans that address evidence gaps.
  • Partner with the registry steering committee and effectively manage external stakeholder expectations regarding strategic objectives and execution of research.
  • Accountable to drive and deliver the operational execution activities (data input, review, querying, cleaning, completeness monitoring) related to publications and supervise internal and external personnel involved in the execution of these activities such as Clinical Operations, CRO, sites, data management team and Biometrics.
  • Co-lead the statistical methodology for all registry initiatives in partnership with the Biometrics team. Should possess excellent understanding of bioinformatics, statistical concepts, and analytical software(s). Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
  • Ensure a comprehensive and current view of all evidence generation activities for the real-world registry. Accountable for ensuring all ongoing research activities across alliance are in accordance with the Imbruvica Medical Affairs strategy.
  • Propose amendments, supervise and be knowledgeable of the registry budgets vis-à-vis Medical Affairs plans.
  • Ensure compliance with internal SOPs and processes, working across functional areas to approvals on contracts, protocol amendments, and study documents, as necessary.
  • Acts as real-world expert and contributes meaningfully to the design of pertinent research to better help understand CLL patients' journey, as well as to maximize stakeholder reception of insights across healthcare providers, payers, and patient advocacy groups.
  • Represent AbbVie externally through conference presentations/ communications/ publications in peer reviewed journals. Author studies with independent, critical thinking to ensure quality and completeness of output, oversee timeline for deliverables associated with analysis and reporting of publications.
  • Provide mentorship and guidance for staff and other junior employees within Medical Affairs.
  • Serve as a cross functional link with Clinical Operations, CRO, sites, data management team and Biometrics by participating in operational design on existing or developing registry studies and participates on cross-functional data generation related initiatives (interfacing with field medical team on insight gathering).
  • Serve as operational lead/facilitator of registry governance teams such as the InformCLL Joint Working Group, steering committee meetings, SMTs, field team touchpoints, and others as needed.


Qualifications

Qualifications

  • Master's or PhD in Pharmacy Outcomes Research, Economics, Health Services Research, Bio Statistics, Epidemiology, Health Policy, Public Health or a related discipline.
  • At least 5 years of experience in observational research study management and/or data analytics in the healthcare industry is required. Experience with other types of HECOR/RWE studies is preferred. Oncology/Hematology registry experience preferred.
  • Expertise in Statistical/analytical programming skills in SAS and/or R software highly preferred.
  • 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. Familiarity with the role and importance of outcomes research and real-world evidence in the biopharmaceutical industry
  • Deep understanding of US healthcare environment especially with respect to oncology class of medications is required. Knowledge of the payer and managed care landscape including value-based outcomes is preferred.
  • Strong interpersonal skills and ability to collaborate on cross-functional teams
  • Ability to navigate ambiguous, complex, and difficult situations.


Significant Work Activities
N/A
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.