At a Glance
- Tasks: Lead innovative pharmacometrics strategies for drug development and analysis.
- Company: Join Jazz Pharmaceuticals, a global biopharma innovating life-changing medicines.
- Benefits: Competitive salary, bonuses, flexible vacation, and comprehensive health benefits.
- Other info: Collaborative environment with opportunities for career growth and development.
- Why this job: Make a real impact on patients' lives through pioneering research and development.
- Qualifications: PhD in relevant fields with 5+ years of experience in pharmacokinetics.
The predicted salary is between 63000 - 77000 £ per year.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
This position is responsible for leading efficient, innovative population PK, PK/PD, exposure-response plan, analysis, interpretation, and reporting to support international drug development programs. Working through cross-functional teams, this individual will lead the overall pharmacometrics strategy for multiple Jazz portfolio products, from research to registration and beyond.
Essential Job Functions:
- Development of the pharmacometrics strategy of multiple programs
- Design, perform, interpret and report population PK, PK/PD and exposure-response analyses
- Provide hands-on population PK and PK/PD modeling and simulation support for development projects, e.g., dose selection and optimization
- Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA’s, IB’s, etc.). This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
- Plan, prepare and review drug development plans and regulatory filings
- Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents
- Address queries from regulatory agencies during reviews and inspections
- Identify and manage consultants and vendors supporting pharmacometrics analyses
- Effective participation on cross functional teams to ensure effective integration of Model Informed Drug Development (MIDD) principles
Required Knowledge, Skills, and Abilities:
- PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis
- Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
- Prior working experiences in performing modeling and simulation tasks using software for PK/PD analysis (eg, NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK Sim, etc.)
- Experience in regulatory agency interactions is a plus
- Ability to work both independently and collaboratively in a multidisciplinary team environment
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment
- Excellent written and oral communication skills including good presentation skills
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.
Associate Director, Pharmacometrics employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharma industry. With a strong commitment to employee growth, we provide numerous opportunities for professional development and a competitive benefits package, including flexible paid vacation and comprehensive health insurance. Located in vibrant cities like London and Cambridge, our employees enjoy a stimulating environment that fosters creativity and teamwork while making a meaningful impact on patients' lives worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Pharmacometrics
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We think you need these skills to ace Associate Director, Pharmacometrics
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Jazz Pharmaceuticals!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Jazz Pharmaceuticals that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Jazz Pharmaceuticals!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Jazz Pharmaceuticals, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Jazz Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Jazz Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
