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CSL · 2 weeks ago

Director, Epidemiology

Greater Philadelphia

Full-time

Hybrid

Director/Executive

10+ years exp

CSL Behring is a global biotechnology leader committed to saving and improving lives through innovative therapies. The Director of Epidemiology will lead epidemiology research strategies to support R&D and commercial objectives, manage research programs, and contribute to regulatory submissions and internal decision-making processes.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Hiring Manager

Jamie O'Malley

Responsibilities

As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives

Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports

Contribute epidemiological data 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)

Lead structured benefit-risk assessments, using qualitative and quantitative methods

Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company

Assist the head of department to facilitate ongoing development and growth of the department

Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc

Qualification

EpidemiologyQuantitative analysisCross-functional leadershipPharmaceutical industry experienceRegulatory submissionsChange managementProcess improvementTeam collaboration

Required

Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry

Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard

Sustained autonomous performance as epidemiology lead to 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

Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting

Demonstrated experience leading organizational process improvement or change management initiatives

Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities

Company

CSL

Glassdoor4.6

CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.

Founded in 1916

Melbourne, Victoria, AUS

10001+ employees

https://www.csl.com

Funding

Current Stage

Public Company

Total Funding

$111M

2013-12-20Acquired

2004-02-06Post Ipo Equity· $111M

1994-06-03IPO

Leadership Team

Jeffrey Ball

Chief Sustainability Officer

Joy Linton

Strategic Advisor

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