Associate Director, Epidemiology

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

JOB PURPOSE

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 Science 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.

RESPONSIBILITIES AND ACCOUNTABILITIES

1. 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.

2. 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.

3. Lead the execution of structured benefit-risk assessments, using qualitative and quantitative methods as appropriate.

4. 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).

5. Plan, coordinate and execute all aspects of contracting and oversight of work conducted by external parties (e.g., CROs, academic investigators).

6. 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.

7. 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.

8. Actively contributes to CSLB organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.

9. 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).

REPORTING RELATIONSHIP

Reports To: Head, Clinical Epidemiology

Direct Reports: None

JOB REQUIREMENTS

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.

Experience ( Minimum years of experience and knowledge required to perform the job.)

• 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.

Competencies ( Measurable or observable skills, abilities, and behaviors critical to successful job performance .)

• 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)

Travel Requirements (Domestic, International, frequency)

Some domestic or international travel necessary.