We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.
About the role:
This role presents an exciting opportunity to lead the pharmacoepidemiology strategy to support our clinical, medical, and regulatory programs and thereby unlock the potential of cannabinoid science to transform the lives of patients and their families. The Director, Pharmacoepidemiology, Benefit-Risk Lead will represent pharmacoepidemiology in integrated evidence teams, medical safety teams, and other cross-functional teams across R&D.
Responsibilities:
Craft and execute effective and efficient pharmacoepidemiology strategies. Contribute to integrated evidence generation strategies/plans.
Lead structured benefit-risk assessments and contribute to benefit-risk process development, including quantitative benefit-risk methods.
Drive epidemiology strategy for risk management activities with the risk management lead.
Develop and drive real world evidence strategies across products in collaboration with R&D partners, including comparative safety and comparative effectiveness studies.
Conduct PASS, PMRs and other health authority mandated studies.
Serve as the pharmacoepidemiology subject matter expert on cross-functional teams including safety teams and integrated evidence teams.
Apply novel and innovative epidemiology methods to support clinical development, regulatory affairs, and pharmacovigilance throughout the development lifecycle, from discovery to lifecycle management.
Serve as an internal consultant on epidemiology methods, observational study design and novel analytic approaches to real world evidence generation.
Contribute to publication and dissemination of pharmacoepidemiology studies.
Represent pharmacoepidemiology strategy during engagement with GW stakeholders.
Embody GW values in all professional settings and interactions, with a focus on integrity and excellence.
Responsible for oversight of any PV input regarding the design, analysis, and interpretation of pharmacoepidemiology studies and observational data.
Establish pharmacoepidemiology standards, processes & policies by defining principles and methods for conducting epidemiological evaluation of safety issues, in close collaboration with relevant GW stakeholders.
Promote use of state-of-the-art pharmacoepidemiology strategy, standards, processes, and methodologies (standard and advanced).
Provide critical appraisal of observational studies and study protocols across the company.
Manage and mentor junior epidemiology colleagues.
Required Experience:
Doctoral degree, epidemiology or related discipline.
6+ years biopharmaceutical industry experience with direct exposure to clinical, regulatory or pharmacovigilance functions.
Strong academic experience and publication record.
Significant and demonstrable working knowledge of PE and pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
Superlative verbal and written communication.
Able to lead meetings, present orally and interact with external bodies.
Able to work effectively and influence across cultures and functions.
Proven strategic thinking and problem-solving skills and able to work independently.
Able to manage multiple projects simultaneously and has excellent time management skills.
Able to maintain composure in stressful/adverse situations.
