Senior Manager, Epidemiology

Initial Therapeutics, Inc.; Deutschland; Remote; EUR 122.000 - 183.000; Vollzeit

Benefits dieser Stelle

Remote work options

Zusammenfassung

Jazz Pharmaceuticals seeks a Senior Manager of Epidemiology to lead non-interventional pharmacoepidemiology studies and oversee PMR/PMC commitments. You will provide scientific leadership, identify epidemiology data for regulatory submissions, and collaborate with Regulatory, Medical Affairs and Biostatistics.

Responsibilities include coordinating external CROs, developing statistical analysis plans, and presenting findings at scientific meetings.

Qualifikationen

• Advanced degree in epidemiology or related field.
• Minimum 2 years in pharma, CRO, or academia.
• Experience with rare disease studies.
• Experience coordinating cross-functional processes.
• Strong English communication and biostatistics knowledge.

Aufgaben

• Lead non-interventional pharmacoepidemiology studies and PMR/PMC activities.
• Identify data for regulatory submissions and RMPs/PBRERs.
• Develop statistical analysis plans with biostatisticians.
• Manage external investigators and CROs to deliver timely results.
• Communicate timelines and study status to regulatory leads.

Kenntnisse

Epidemiology

Regulatory submissions

Cross-functional

Project management

Secondary data analysis

Biostatistics

English proficiency

RWE platform

Ausbildung

MS/MPH/MSPH/PhD in epidemiology

Tools

SAS

Stata

R

Jobbeschreibung

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate totransform the lives of patients and their families. We are dedicated to developinglife-changing medicines for people with serious diseases — often with limited or notherapeutic options. We have a diverse portfolio of marketed medicines, including leadingtherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.Our patient-focused and science-driven approach powers pioneering research and developmentadvancements across our robust pipeline of innovative therapeutics in oncology andneuroscience. Jazz is headquartered in Dublin, Ireland with research and developmentlaboratories, manufacturing facilities and employees in multiple countries committed toserving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Brief Description:

A Senior Manager (SM) of Epidemiology will support the epidemiological activities of Jazz’ Global Research & Development (R&D) organization. This role will be responsible for the scientific leadership and operational management of non-interventional pharmacoepidemiology studies, including studies designed to address Jazz’s post-marketing requirements/commitments (PMR/PMC) to regulatory authorities. This role will also be responsible for identifying relevant epidemiology data for regulatory submissions and documents developed to support clinical development of investigational medicines in Jazz’ R&D portfolio, including Risk Management Plans (RMPs), Periodic Benefit-Risk Reports (PBRERs), orphan designation applications and others. The SM will report to the Senior Director of Epidemiology.

Essential Functions/Responsibilities

• Conduct/outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, and cross-sectional studies describing the demographics, co-morbidities, treatment patterns and concomitant medications of the target patient populations in different geographies
• Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs (e.g., RMPs, safety query responses, orphan drug applications, pediatric waivers, and external control arms) and other processes requiring epidemiological data
• Provide top of the patient funnel data for forecasting/commercial purposes
• Identify appropriate US and EU secondary data sources for studying the target patient populations (e.g., administrative claims and electronic medical records (EMR) databases)
• Lead Requests for Proposal (RFP) and Statement of Work for soliciting proposals and budgets from CROs and Data Providers for outsourced epidemiology studies
• Support a multi-disciplinary non-interventional Phase IV study team to deliver study-related regulatory submissions (e.g., protocols, statistical analysis plans, progress reports, interim study results and final study reports) in accordance with applicable regulatory guidelines and the PMR/PMC timetable set by a Health Authority
• Develop statistical analysis plans in collaboration with the project biostatistician (including those for analyses of administrative claims and EMR databases)
• Manage external investigators, project managers and operational leads at Contract Research Organizations (CROs) and/or Data Providers for outsourced studies to deliver high-quality results on time
• Communicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMC
• Develop strong partnerships with internal stakeholders (e.g., Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs) to ensure that the appropriate epidemiological support is provided in their respective processes
• Communicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on time
• Present research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines

Required Knowledge, Skills, and Abilities

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)
• At least 2 years of experience in the pharmaceutical industry, CRO or in academia
• Experience with rare disease studies
• Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
• Experience successfully coordinating cross-functional processes
• Experience analyzing secondary data sources (administrative claims and EMR databases)
• Excellent oral and written communication skills in English
• Solid understanding of epidemiology and biostatistics
• Experience managing multiple projects and reprioritizing work when necessary
• Capable of working remotely with minimal supervision
• Proficiency with MS Word, Excel and PowerPoint
• Ability to travel approximately 10% time

Required/Preferred Education and Licenses

• Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
• Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
• Experience conducting post-marketing safety studies of marketed medicines
• Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company
• Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities
• Data analysis programming skills (SAS, Stata, R) or recent hands‑on experience using an RWE platform technology

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Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $141,600.00 - $212,400.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings https://careers.jazzpharma.com/benefits.html.