Talent.com
Johnson & Johnson
Senior Scientist Clinical PharmacokineticsJohnson & Johnson • High Wycombe, United Kingdom
Senior Scientist Clinical Pharmacokinetics

Senior Scientist Clinical Pharmacokinetics

Johnson & Johnson • High Wycombe, United Kingdom
30+ days ago
Job type
  • Full-time
  • Temporary
Job description
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.

Job Description
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 (in collaboration with the CPP Leader), the following activities of end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1-owned studies including: protocol development, pharmacokinetic/pharmacodynamic data analysis, and generating the in-text tables and figures and PK/PD attachments for clinical study reports and CP CSR section writing, as well as 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 (i.e., Translational Medicine, etc.) where there is serial PK/PD sampling and where non-compartmental analysis (NCA) is required, participate in the development and review of CP sections of the document.
  • If necessary, participate in protocol training of PK/PD-related procedures for clinical study center personnel (i.e., SIV).
  • Provide QC review of protocols written by other CPP PK Scientists.
  • Review non-comparatmental analysis (NCA) trial specific data transfer agreements (tsDTA) provided by the PK Office Vendor for the creation of PK/PD analysis datasets.
  • Creates the Clinical Pharmacology Analysis Plan based on the protocol.
  • Performs pre-DBL, interim, and final NCA for trials in all phases of drug development. Prepares the final NCA output including in-text tables and graphs (and PK/PD attachments) for the Clinical Study Report [CSR], and if necessary, internal and external departmental data communications (i.e., presentations).
  • Create a data review document with data handling rules for review by the CPP Leader prior to conducting the final analysis.
  • Performs QC for analysis performed 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 CSRs under the ownership of the therapeutic area (i.e., Translational Medicine, Experimental Medicine, etc.) where there is serial PK and/or PD sampling and where NCA is required, develop the CP sections of the document.
  • Performs CP section CSR review and QC for other CPP PK Scientists.
  • For regulatory submission documents (e.g., NDA, sNDA, etc.), provide tables and figures for study-specific summaries and if necessary, support the development of other PK/PD related sections.
  • Establish and maintain excellent/cooperative relationships with other departments (Data Management, BDDS, GCO, Regulatory, etc.) to facilitate the on-time (or expedited) deliverables.
  • Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
  • Ensures all study documentation generated by CPP are properly managed and maintained on the CPP Repository, and are ultimately submitted for long-term storage in archival per Johnson & Johnson Record Retention Schedules.
  • Mentor junior CPP PK Scientists on medical writing and NCA.

Other Accountabilities & Tasks
  • Perform literature searches and summarize 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 matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
  • Become familiar and apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies.
  • Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact.

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 (e.g. SDTM, ADaM)
  • Experience with Phoenix WinNonlin is a must and R is preferred.
  • Working knowledge of Microsoft suite of software products.
  • Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
  • Good oral and written communication skills.
  • General understanding of overall process of drug development and the overall pharmaceutical R&D process is preferred.
  • Estimated both domestic and international travel of about 5% of time.

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.
Create a job alert for this search

Senior Scientist Clinical Pharmacokinetics • High Wycombe, United Kingdom

Similar jobs

Senior Scientist

LonzaSlough, England, GB
Full-time

Join a cutting-edge R&D team at Lonza, where you will help advance next-generation purification technologies.This is an exciting laboratory-based role ( on site 5 days a week) focused on developing... Show more

 • Promoted

Associate Director, Biostatistics

CSLMaidenhead, England, United Kingdom
Temporary

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program.The AD provides statistical strategies for the clinical trials and reg... Show more

 • Promoted

Senior Pharmacometrician: PK Modeling & Regulatory Strategy

AllucentBracknell, England, GB
Full-time

Allucent is looking for an Associate Director/Director, Pharmacometrician in Bracknell, UK.You will lead high-impact modeling and simulation efforts while mentoring teams and guiding clients throug... Show more

 • Promoted

Research Associate - Executive Search

Fair RecruitmentNewport Pagnell, ENG, GB
Full-time

My client is a strategic talent consultancy specialising in the global consumer goods sector.They provide talent solutions to leading organisations through leadership search, talent mapping, talent... Show more

 • Promoted

Senior Inpatient Psychiatrist & Clinical Lead

Surrey and Borders Partnership NHS Foundation TrustChertsey, England, United Kingdom
Full-time

The Surrey and Borders Partnership NHS Foundation Trust is seeking a Consultant Psychiatrist for its adult inpatient service at the Orion Ward.This role involves providing psychiatric input to inpa... Show more

 • Promoted

Senior Metrology Engineer

SafranMilton Keynes, United Kingdom
Full-time

Bonus, Excellent Pension, 33 Days Holiday, Dental, BUPA, Workplace nursery scheme, Midday finish on Fridays, Enhanced family friendly policies, Wellbeing programme, Employee assistance programme in... Show more

 • Promoted • New!

Senior Medical Manager, Medical Affairs Uk & I (3 days/week onsite in Maidenhead)

CSL Behring (Cielo)Maidenhead, ENG, GB
Full-time

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.Wi... Show more

 • Promoted

Analytical Associate Scientist — HPLC/GC for Pharma R&D

MedPharmGuildford, England, GB
Full-time

MedPharm in Guildford seeks an Associate Scientist (Analytical) to perform analytical testing of pharmaceutical compounds, drug substance and drug product, supporting early and late development.You... Show more

 • Promoted

Senior Scientist, Pharmacometrics

LifelancerHigh Wycombe, England, GB
Full-time +1

Senior Scientist, Pharmacometrics.At Johnson & Johnson we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treat... Show more

 • Promoted

Principal Scientist PK/PD

UCBSlough, England, GB
Full-time

Principal Scientist, Non-Clinical PKPD.We are looking for a Principal Scientist, Non-Clinical PKPD, who is innovative and agile to join us in our Clinical Development Sciences Group, based at the R... Show more

 • Promoted

Senior PKPD Scientist - Nonclinical & Regulatory PKPD

SRGSlough, England, GB
Full-time

A global biopharmaceutical leader is seeking a Principal Scientist (PKPD) to lead non-clinical PKPD strategy and oversee GLP toxicokinetics studies.The role involves delivering regulatory data pack... Show more

 • Promoted

Neurodegeneration Clinical Lead for RNAi Therapeutics

Alnylam PharmaceuticalsMaidenhead, England, United Kingdom
Full-time

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer to provide clinical leadership in RNAi therapeutics across diverse disease areas.Director, Clinical Research will lead cli... Show more

 • Promoted

Associate Director, Biostatistics (2)

CSL Plasma Inc.Maidenhead, England, United Kingdom
Temporary

Associate Director, Biostatistics (2)Bewerbenlocations: EMEA, GB, Berkshire, Maidenhead, CSL Behring: Americas, US-MA, Waltham, CSL Behring: Americas, US-PA, King of Prussia, CSL Behring: E... Show more

 • Promoted

Senior Scientist Clinical Pharmacokinetics

6010-Biosense Webster Inc. Legal EntityHigh Wycombe, England, GB
Temporary

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 Clinica... Show more

 • Promoted

Field Service Engineer, Medical X-Ray Systems

TRS ConsultingMillbrook, ENG, GB
Full-time

Field Service Engineer, Medical X-Ray Systems.On Target Earnings £70,000.Opportunity to use train and underground (full expensed) when applicable.Excellent opportunities for experienced X-ray... Show more

 • Promoted

Senior Biostatistics Lead, Clinical Development

CSL Plasma Inc.Maidenhead, England, United Kingdom

CSL Behring sucht einen Associate Director Biostatistics, der die statistische Gesamtführung in einem klinischen Entwicklungsprogramm übernimmt.Sie definieren Strategien, leiten Designs und Analyse... Show more

 • Promoted

Senior Biostatistics Lead, Clinical Development

CSLMaidenhead, England, United Kingdom
Full-time

CSL in Maidenhead, UK, seeks an Associate Director, Biostatistics to lead the statistical contribution across a clinical development program.You will define strategies for trials and regulatory sub... Show more

 • Promoted

Senior Medical Director, Clinical Research - Neurodegeneration

Alnylam PharmaceuticalsMaidenhead, England, United Kingdom
Full-time

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer.This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portf... Show more

 • Promoted

Senior PK Scientist - Clinical Pharmacology & PK/PD

6010-Biosense Webster Inc. Legal EntityHigh Wycombe, England, GB
Full-time

Johnson & Johnson is looking for a Senior Scientist Clinical Pharmacokinetics based in High Wycombe, UK.This role involves overseeing Phase 1 study execution, including protocol development, data a... Show more

 • Promoted

Senior Scientist – Synthesis Research Chemistry

Syngenta GroupBracknell, England, GB
Full-time

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.At Syngenta Crop Protection, we're pioneering solutions that safeguard global food security while ch... Show more