At a Glance
- Tasks: Lead clinical pharmacokinetics studies and analyse data to develop life-saving treatments.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and patient-focused solutions.
- Benefits: Enjoy competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with mentorship opportunities and career advancement.
- Why this job: Make a real impact on global health by developing the medicines of tomorrow.
- Qualifications: Bachelor's degree in science and 4+ years of clinical experience required.
The predicted salary is between 61200 - 74800 £ per year.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
The Senior Scientist Clinical Pharmacokinetics (PK Scientist) role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for the following activities of end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies:
- Protocol development
- Pharmacokinetic/pharmacodynamic data analysis
- Generating in-text tables and figures and PK/PD attachments for clinical study reports
- CP CSR section writing
- Study summary contributions to CTD regulatory submission documents
Additional responsibilities include the support of all other studies in any phase of development which include noncompartmental clinical pharmacology analysis (and all associated activities). The PK Scientist role is also responsible for PK/PD NCA for all study phases (Phase I-IV).
Main Accountabilities:
- For clinical trial protocols under the ownership of CPP, author the CP sections of the protocol, coordinate the overall development of the protocol, and ensure timely approval and issuance of the document.
- For clinical trial protocols under the ownership of the therapeutic area, participate in the development and review of CP sections of the document.
- Provide QC review of protocols written by other CPP PK Scientists.
- Review non-comparatmental analysis (NCA) trial specific data transfer agreements provided by the PK Office Vendor for the creation of PK/PD analysis datasets.
- Create the Clinical Pharmacology Analysis Plan based on the protocol.
- Perform pre-DBL, interim, and final NCA for trials in all phases of drug development.
- Prepare the final NCA output including in-text tables and graphs for the Clinical Study Report [CSR].
- Create a data review document with data handling rules for review by the CPP Leader prior to conducting the final analysis.
- Perform QC for analysis performed by other CPP PK Scientists.
- For CSRs under the ownership of CPP, develop the CPP sections, and facilitate a timely review and approval of those sections.
- For regulatory submission documents, provide tables and figures for study-specific summaries.
- Establish and maintain excellent relationships with other departments to facilitate on-time deliverables.
- Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
- Ensure all study documentation generated by CPP are properly managed and maintained.
- Mentor junior CPP PK Scientists on medical writing and NCA.
Other Accountabilities & Tasks:
- Perform literature searches and summarise the findings.
- Contribute to preparation of IB, INDs, briefing books, submission package, and other regulatory documents.
- Work effectively in a matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Become familiar and apply appropriate regulatory guidelines in the design of clinical development plans and studies.
- Apply relevant technical trainings/learnings to daily responsibilities.
Requirements:
- Bachelor’s degree or higher and/or equivalent preferably with science background.
- Minimum of 4 years of clinical experience.
- Knowledge of PK, PD, and statistical principles.
- Excellent data handling skills and working knowledge of database structures.
- Experience with Phoenix WinNonlin is a must and R is preferred.
- Working knowledge of Microsoft suite of software products.
- Demonstrated organizational and leadership skills.
- Good oral and written communication skills.
- General understanding of overall process of drug development is preferred.
Required Skills:
- Analytical Reasoning
- Clinical Data Management
- Clinical Pharmacology
- Clinical Trials Operations
- Coaching
- Critical Thinking
- Drug Discovery Development
- Empowering People
- Pharmacokinetic Modeling
- Pharmacokinetics
- Pharmacology
- Pharmacometrics
- Program Management
- Report Writing
- Scientific Research
- Technologically Savvy
Location: High Wycombe, Buckinghamshire, United Kingdom
Type: Full time
Senior Scientist Clinical Pharmacokinetics in Milton Keynes employer: Johnson & Johnson
Johnson & Johnson in High Wycombe is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Employees benefit from comprehensive growth opportunities, competitive compensation, and a commitment to compliance excellence, making it a rewarding environment for those passionate about quality systems and regulatory standards.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Scientist Clinical Pharmacokinetics in Milton Keynes
✨Get Involved in Research Communities
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We think you need these skills to ace Senior Scientist Clinical Pharmacokinetics in Milton Keynes
Some tips for your application 🫡
Highlight Your Research Experience:When applying for a full-time role in scientific research, make sure to emphasise your research experience prominently in your CV. Share specific projects you’ve worked on, the methodologies you used, and any significant findings. If you’ve published papers or presented at conferences, definitely include that too – it shows you’re on it in the academic world!
Tailor Your Cover Letter to the Research Area:Your cover letter should reflect your passion for the specific area of research at Johnson & Johnson. Mention relevant experiences that align with the organisation’s goals or projects. This shows that you’ve done your homework and are genuinely interested in the position – plus, it helps us see how you’d fit into the team dynamics.
Showcase Your Data Analysis Skills:In scientific research, data analysis skills are a big deal! Make sure to detail any relevant analytical tools or software you’re familiar with, like R, Python, or statistical packages. Employers are keen to know you can handle the data-heavy elements of the role, so add specific examples where you’ve used these skills effectively.
Discuss Your Future Research Goals:In your motivation section, it’s a great idea to talk about your future research goals and how they align with the work being done at Johnson & Johnson. This shows that you’re not just looking for any job, but rather a chance to contribute meaningfully to the field. We love to see applicants who are forward-thinking and enthusiastic about their research journey!
How to prepare for a job interview at Johnson & Johnson
✨Showcase Your Research Skills
In scientific research, it’s crucial to demonstrate your ability to design and conduct experiments. Come armed with examples of past projects where you've developed hypotheses, collected data, and analysed results. Be ready to discuss any specific methodologies or tools you’ve used, like PCR techniques or statistical software.
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✨Know Your Publications
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✨Exhibit Your Team Spirit
In full-time roles, collaboration is often at the heart of scientific research. Prepare examples that show how you've successfully worked in teams, dealt with conflicts, or contributed to group projects. We want to know how you can work effectively with the team at Johnson & Johnson to drive research projects forward.
