Senior Scientist Clinical Pharmacokinetics

This job is with Johnson & Johnson, an inclusive employer. 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.

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.

Johnson & Johnson is currently seeking a Senior Scientist Clinical Pharmacokinetics (PK Scientist) to join our team. 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.
• Participate in the development and review of CP sections of the document for clinical trial protocols under the ownership of the therapeutic area where serial PK/PD sampling and non-compartmental analysis (NCA) is required.
• 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 and support the development of other PK/PD related sections.
• Establish and maintain excellent relationships with other departments to facilitate on-time deliverables.
• 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 as applicable to support clinical studies and/or programs.
• 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 a 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