Senior Scientist Clinical Pharmacokinetics
il y a 2 semaines
The Senior Scientist, Clinical Pharmacokinetics role within Clinical Pharmacology and Pharmacometrics (CPP) is responsible for (in collaboration with the Clinical Pharmacology Leader), the following activities of end-to-end Phase 1 study execution of Clinical Pharmacology Phase 1 studies including: protocol development, pharmacokinetic/pharmacodynamic data analyses, and generating the in-text tables, figures and PK/PD attachments for Clinical Study Reports (CSR) and CP CSR section writing, as well as study summary contributions to CTD documents.
Additional responsibilities include the support of all other studies in any phase of development which include noncompartmental analyses (and all associated activities).
Your principal responsibilities:
- For Phase 1 clinical pharmacology trial protocols, author the CP sections of the protocol, coordinate the overall development of the protocol, and ensure timely approval and issuance of the document.
- Provide QC review of protocols written by others, including other PK Scientists.
- Review noncompartmental analysis (NCA) trial specific data transfer agreements (tsDTA) for the creation of PK/PD analysis datasets.
- Create the Clinical Pharmacology Analysis Plan based on the protocol.
- Perform predatabase lock, interim, and final NCA for trials in all phases of drug development. Prepare the final NCA output including intext tables and graphs (and PK/PD attachments) for the CSR.
- Create a logbook with data handling rules for review by the Clinical Pharmacology Leader prior to conducting the final analysis.
- Perform QC for analyses performed others, including other PK Scientists.
- Develop the CP sections of CSR for Phase 1 Clinical Pharmacology trials, and facilitate a timely review and approval of those sections.
- Perform CP section CSR review and QC for other PK Scientists.
- For regulatory submission documents (e.g., NDA, sNDA, MAA, Type II variation etc.), provide tables and figures for studyspecific 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, Regulatory, etc.) to facilitate the ontime (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 longterm storage in archival per Johnson & Johnson Record Retention Schedules.
- 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.
Qualifications:
Education and Experience Requirements
- Bachelor's degree or higher and / or equivalent preferably with science background. Minimum of 6+ 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 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 in English.
- General understanding of overall process of drug development and the overall pharmaceutical R&D process is preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
-
Clinical Pharmacology and Pharmacometrics Intern
Il y a 2 mois
Beerse, Flandre, Belgique Randstad Temps pleinClinical Pharmacology and Pharmacometrics (CPP) is an integrated part of the Global Development organization within Johnson & Johnson Innovative Medicines. We work in cross-disciplinary compound development teams and apply clinical pharmacology principles and pharmacometrics methodologies across the R&D portfolio to enable optimal decision-making in drug...
-
Director, Clinical Project Scientist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinEssential Functions: Executes clinical research strategies and contributes to the development and execution of clinical research programs Directs end to end delivery of clinical studies Defines clinical study parameters, supports deliverables, policy compliance and resource needs Serves as a clinical point of contact for cross functional teams and program...
-
Senior Scientist, Nonclinical Submission Writer
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Nonclinical Submission Writer within Nonclinical Safety at our Beerse, Belgium, or Spring House, PA locations.Key Responsibilities: Accountable for planning, writing, reviewing, editing, and finalizing regulatory documents for...
-
Senior Scientist Computational Chemistry
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinCenter of Excellence for Predictive Analytics and Stability Sciences (CoE PASS) is part of the Global Analytical Development Synthetics organization within the Therapeutics Development & Supply (TDS) department of Janssen R&D. In the CoE PASS we are a team of experimental and computational scientists that focuses on using and developing accelerated studies...
-
Senior Scientist, Toxicology
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Toxicology located in Beerse, BE.This Senior Scientist in Global Toxicology, a department in the Preclinical Science and Translational Safety (PSTS) organization within Janssen Research & Development supports nonclinical safety...
-
Associate Scientist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinTemporary contract of 11 months.The Small Molecule Method Development (SMMD) group of J&J Innovative Medicine is recruiting for a (Senior) Associate Scientist **, located in Beerse, Belgium.As (Senior) Associate Scientist **, you will join the Small Molecule Method Development (SMMD) group within the Analytical Development department, which is part of the...
-
Senior Scientist, Molecular Pathology
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinSenior Scientist - Molecular Pathology - Location: Beerse, Belgium**Function: PSTS-Molecular pathologySenior Scientist, Molecular PathologyThriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. We are proud to be an equal opportunity employer.Primary Responsibilities: Accountability for the design,...
-
Senior Scientist, in Vitro Models Electrophysiology
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinSenior Scientist, in vitro electrophysiology - Neuroscience:Janssen Research and Development is recruiting for a Senior Scientist to join the Neuroscience Discovery team located in Belgium, working in the field of Neurodegenerative and Neuropsychiatric Diseases with a focus on Alzheimer's disease, Parkinson's disease, Psychosis, and Depression.Your key...
-
Senior Associate Scientist, Biosignature
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinWe are looking for a Senior Associate Scientist to join our Biosignature team at Janssen located in the Antwerpen region, Belgium.In this role you will be responsible for screening and profiling of compounds and other modalities in High Dimensional Biology assays using High Content Imaging to support drug discovery and biosignature method development. You...
-
Director, E2e Clinical Supply Planning
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinOur ValuesAt Janssen Pharmaceutics, everyone is committed to make a difference in people's lives and to push the boundaries of what science and innovation can achieve. The values that guide our decision-making are spelled out in Our Credo. Put simply, Our Credo challenges us to put the needs and well-being of the people we serve first, our patients, doctors...
-
Scientist, Oral Solids Development
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt Janssen we strive to improve life and outcomes of millions of patients worldwide. Do you want to be a true pioneer and join us in our journey towards the development of innovative therapeutics delivered orally? If so, this Scientist role could be an exciting opportunity to exploreAbout the Department:The Global Pharmaceutical Product Development and...
-
Associate Scientist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinWe at the Janssen Pharmaceutical Companies of Johnson & Johnson are recruiting for a motivated In Vitro Associate Scientist, located in Beerse.Janssen conducts research and development in a variety of therapeutic areas to discover novel therapeutic approaches to address unmet medical conditions. Janssen has a rich portfolio of small and large molecules, as...
-
Scientist Crs
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinWorking with Johnson & Johnson can change everything. Including YOU.Janssen R&D, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist for the Department of Analytical Development - Clinical Release and Stability, located in Beerse, Belgium.The Clinical Release and Stability (CRS) team is a critical part of the Global Analytical...
-
Scientist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist , Global Discovery Bioanalysis located in Beerse, Belgium.The scope of this role will include:Responsible for all technical aspects of bioanalytical method development activities to characterize in vivo PK and biodistribution for early...
-
Senior Associate Scientist
Il y a 2 mois
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinPharmaceutical and Material Sciences is a department of Chemical & Pharmaceutical Development & Supply (CPDS) of Janssen Research & Development. Within the department resides the High-Throughput and Preformulation Sciences (HTPS) team, leading activities to understand the physicochemical and biopharmaceutical properties of potential drug candidates and their...
-
Scientist Analytical Project Lead
il y a 2 semaines
Beerse, Flandre, Belgique Randstad Temps pleinIn the Clinical Release and Stability (CRS) team, we are looking for a Stability Project Owner (scientist).The Clinical Release and Stability (CRS) team is a critical part of the Analytical Development department in the Discovery, Product Development & Supply (DPDS) organization within Janssen R&D and strives for a fully scientific understanding of the...
-
Scientist Analytical Project Lead
il y a 4 semaines
Beerse, Flandre, Belgique Randstad Temps pleinIn the Clinical Release and Stability (CRS) team, we are looking for a Stability Project Owner (scientist).The Clinical Release and Stability (CRS) team is a critical part of the Analytical Development department in the Discovery, Product Development & Supply (DPDS) organization within Janssen R&D and strives for a fully scientific understanding of the...
-
Scientist Liquid Chromatography
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAbout Johnson & Johnson:Small Molecule Method Development is a department within the Global Analytical Development department in the Therapeutics Development and Supply (TDS) organization within Johnson & Johnson Innovative Medicine R&D. The department is responsible for Small Molecule Method Development, Method Validation, Method Transfer and support. This...
-
Senior Site Manager
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinJob Description - Senior Site Manager W) Senior Site Manager W Description 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...
-
Senior Associate Scientist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinWithin the HTPS team, there is a full-time opening for aScientist High-Throughput & Preformulation SciencesJob description: Design, plan, execute, interpret and report experiments to understand the physicochemical and biopharmaceutics properties of drug substances and their formulations including solubility, dissolution/precipitation rate, solid state, pKa,...
