Assoc. Dir. Clinical Epidemiology
The Associate Director, Clinical Epidemiology is responsible for leading epidemiological activities for assigned products across therapeutic areas within Clinical Research & Development to facilitate robust, evidence-based decision making. The role proactively identifies the need for epidemiology evidence, and develops and executes research strategies that optimize the contribution of epidemiological data across the span of product lifecycle. In collaboration with cross-functional teams, the Associate Director, Clinical Epidemiology also leads structured benefit-risk assessments of assigned products using qualitative and quantitative methods.
At CSLB the position is located within the Clinical Epidemiology function of the Quantitative Clinical Sciences and Reporting (QCSR) department. The role works closely with other groups across the company including Clinical Research and Development and Commercial Development. The role has potential for matrix management, participation in global teams, interactions with regulatory agencies in multiple countries, and presentation and publication of research outcomes.
Main Responsibilities and Accountabilities:
As the lead epidemiologist, actively participate in internal teams and committees and proactively define appropriate strategies to execute epidemiological research. Goal of the strategy is to ensure high quality epidemiology deliverables across the product lifecycle.
Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.
Lead the execution of structured benefit-risk assessments, using qualitative and quantitative methods as appropriate.
Contribute to reporting of epidemiological data and study results in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).
Plan, coordinate and execute all aspects of contracting and oversight of work conducted by external parties (e.g., CROs, academic investigators).
Participate in discussions with internal and external stakeholders, including regulatory agencies and clinical investigators. Explain epidemiologic concepts and present results of epidemiological programs and studies to internal and external stakeholders with varying levels of epidemiologic research knowledge.
Take responsibility and initiative to advance own technical skills by critical review of emerging methodological literature and attending relevant scientific/professional society meetings. Present and publish at scientific conferences and peer-reviewed journals.
Actively contributes to CSLB organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.
Build and maintain professional relationships and work collaboratively with internal colleagues in other functional lines, consultants, external experts, external partner(s) (e.g., CRO, vendor, alliance partner).
Doctoral degree in Epidemiology, or related quantitative discipline with at least 7 years of relevant experience (preferably in the pharmaceutical industry); or Master’s degree in Epidemiology with at least 8 years of relevant experience in the pharmaceutical industry.
Sustained autonomous performance as Epidemiology lead of multiple projects with regulatory/methodologic complexity. Demonstrated experience in the design, implementation and analysis of epidemiologic studies using primary and secondary data to fulfil Regulatory Agency requirement.
Experience with structured benefit-risk assessment methods (both qualitative frameworks and quantitative analysis) is required.
Experience leading cross-functional teams in a matrix organizational structure at a pharmaceutical industry setting.
Superior understanding of and expertise in advanced epidemiologic methods, observational and experimental study designs and analysis.
Demonstrated experience in the application of qualitative and quantitative structured benefit-risk assessment methods.
Ability to conduct high-quality comprehensive literature reviews and critically interpret epidemiologic data and publications.
Fluency in writing epidemiological sections of scientific and regulatory agency documents (e.g., study protocol, study reports, Risk Management Plan).
Demonstrated consistent ability to strategically plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity. Ability to proactively advise and lead teams in this regard.
Established superior negotiation and influencing skills with cross-functional teams, external collaborators and regulatory agencies related to scientific and operational decisions.
In depth knowledge of drug or vaccine development process and Regulatory pathways including relevant regulations. Demonstrated knowledge (and application of that knowledge) of the big picture of the business (i.e., not only the role of Epidemiology) including Clinical and Commercial development activities.
Sustained demonstration of independently conducting high quality complex research projects.
Knowledge of the major epidemiologic data sources in the USA and Europe including electronic health records, insurance claims databases.
Facility in use of computer systems and data processing software.
Strong interpersonal and organizational skills and ability to prioritize individual workload.
Strong verbal, written and presentation skills and excellent written and spoken English.
Established leader of internal and external strategic initiatives; Represents CSL Behring in external workgroups or initiatives (e.g., Industry-wide, Academic, Professional Societies)
This role reports to: Head, Clinical Epidemiology
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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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