Associate Director, Clinical Pharmacology and Pharmacometrics

Found in: beBee jobs US - 3 weeks ago


House Springs, Missouri, United States Johnson & Johnson Full time
Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:
  • Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.
  • Accountable for all CP trial design, analysis of data, reporting and interpretation of results.
  • Design and execution of appropriate modeling plans along with the Pharmacometric scientist assigned to the project.
  • Entertain strong interactions with opinion leaders beyond Janssen R&D, with a goal to represent CPP and influence the scientific and regulatory environment.
  • Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacodynamic analysis for drug development projects.
  • Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.
  • Will drive early alignment on key development questions where CP principles could be applied.
  • Conduct methodological research and effectively apply state-of-the-art scientific/technical knowledge to projects.
  • Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies.
  • Keep up-to-date knowledge of model-based drug development with a focus on Clinical pharmacology, biopharmaceutics, PKPD & other related analytical sciences including implementation of innovative methods to preclinical research, translational sciences and clinical development.
  • Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, and on time for efficient decision-making.
  • Provide and arrange training and presentations on innovative CP approaches across the R&D organization, ensuring awareness and adequate knowledge about CPP capabilities and expertise within the TA.
  • Plan, conduct, and/or provide oversight of PK and PK/PD analyses and reporting
  • Devise clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternative modeling approaches.
  • Manage and/or supervise operational elements of CPP studies.
  • Develop key product differentiation strategies based on a compound's key attributes and relevant therapeutic landscape
  • Apply appropriate regulatory (eg: FDA, EMA, PMDA, ICH etc) guidelines and define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND's, briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
  • Participate in the evaluation of potential business development opportunities.
  • Stay abreast of clinical pharmacology, MIDD, analysis methodology and overall drug development process, including regulatory guidance, and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.).
  • Assist in process improvement initiatives and SOP development where applicable.

  • Associate Director, Discovery, Product Development

    Found in: beBee jobs US - 1 week ago


    House Springs, Missouri, United States Johnson & Johnson Full time

    Johnson and Johnson is recruiting for an Associate Director, Discovery, Product Development & Supply (DPDS), Strategic Operations located in Spring House, PA; La Jolla, CA or Beerse, BE. 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,...

  • Pharmacokinetics Project Leader

    Found in: beBee jobs US - 1 week ago


    House Springs, Missouri, United States Johnson & Johnson Full time

    Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Pharmacokinetics Project Leader to be located in Spring House, PA or La Jolla, CA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...

  • Director, ATSC

    Found in: beBee jobs US - 3 weeks ago


    House Springs, Missouri, United States Johnson & Johnson Full time

    The Janssen Supply Group, LLC, a member of the Johnson & Johnson Family of Companies is recruiting for a Director, ATSC - MSAT to be based in Spring House PA, Malvern, PA, Horsham, PA or potentially at a NJ site.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are...


  • House Springs, Missouri, United States Johnson & Johnson Full time

    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...

  • Director, Product Communications

    Found in: beBee jobs US - 1 week ago


    House Springs, Missouri, United States Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a Director, Product Communications & Public Affairs, Immunology, located in Spring House, PA. 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,...

  • Registered Nurse

    Found in: beBee jobs US - 6 days ago


    Blue Springs, Missouri, United States Saint Luke's Health System Full time

    Job Description​Our Diabetes & Endocrinology clinic in Lee's Summit, MO is seeking a RN join their team You will be the triage nurse to support the patient population for one of our physicians. The primary responsibilities will be phone triage, prior auths, injections, and assisting the MA with rooming as needed. We are team-oriented, however, so we expect...

  • Registered Nurse

    Found in: beBee jobs US - 1 week ago


    Blue Springs, Missouri, United States Saint Luke's Health System Full time

    Job Description​Saint Luke's Medical Group in Blue springs, MO is seeking a Registered Nurse to join our team. This role will give you the opportunity to phone triage patients.Responsibilities:Utilizes the nursing process Performs patient care, delegating patient care tasks and for supervision of other patient care staff Coordinates the plan of care for a...


  • Spring House, United States Johnson & Johnson Full time

    Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to...


  • Spring House, United States Disability Solutions Full time

    Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to...


  • Spring House, United States Johnson & Johnson Full time

    Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to...


  • Berrien Springs, United States Andrews University Full time

    COUNSELING AND TESTING - Assistant/Associate Director for Clinical Services/Psychologist Job Classification Position summary The Associate Director provides leadership in the clinical services of the Center, including clinical supervision. Maintaining a caseload, the Associate Director provides mental health services for students including counseling,...

  • COUNSELING AND TESTING

    Found in: Talent US C2 - 1 week ago


    Berrien Springs, United States Andrews University Full time

    Job Classification Position summary The Associate Director provides leadership in the clinical services of the Center, including clinical supervision. Maintaining a caseload, the Associate Director provides mental health services for students including counseling, psychoeducation, group counseling, crisis intervention, as well as...


  • Coral Springs, United States Save A Life Recovery LLC Full time

    CLINICAL DIRECTOR-MENTAL HEALTH We are looking for a competent Clinical Director for Mental Health to organize and oversee clients and programs of our clinical department. You will be responsible for supervising and directing everything from employees and budgets to technology and operations. As clinical director you must possess excellent management and...


  • Coral Springs, United States Save A Life Recovery LLC Full time

    CLINICAL DIRECTOR-MENTAL HEALTH We are looking for a competent Clinical Director for Mental Health to organize and oversee clients and programs of our clinical department. You will be responsible for supervising and directing everything from employees and budgets to technology and operations. As clinical director you must possess excellent management and...

  • Clinical Director-Mental Health

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago


    Coral Springs, United States Save A Life Recovery LLC Full time

    CLINICAL DIRECTOR-MENTAL HEALTH We are looking for a competent Clinical Director for Mental Health to organize and oversee clients and programs of our clinical department. You will be responsible for supervising and directing everything from employees and budgets to technology and operations. As clinical director you must possess excellent management and...


  • Coral Springs, United States Save A Life Recovery LLC Full time

    CLINICAL DIRECTOR-MENTAL HEALTH We are looking for a competent Clinical Director for Mental Health to organize and oversee clients and programs of our clinical department. You will be responsible for supervising and directing everything from employees and budgets to technology and operations. As clinical director you must possess excellent management and...

  • Pharmacokinetics Project Leader

    Found in: beBee S US - 3 weeks ago


    Spring House, United States Johnson & Johnson Full time

    Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Pharmacokinetics Project Leader to be located in Spring House, PA or La Jolla, CA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...


  • Clifton Springs, United States FLACRA Full time

    Job DescriptionJob DescriptionJob Summary:In accordance with the organization’s mission, vision and values, the Senior Director of Clinical Operations is responsible for supporting the implementation of agency strategic goals. This includes a strong emphasis on strengthening integrated care and care collaboration across the system. Helping develop new...


  • Defuniak Springs, United States Lake Erie College of Osteopathic Medicine Full time

    Description JOB SUMMARY: We are recruiting a Director of Patient Care Services for LECOM's Dental Outreach Clinic in DeFuniak Springs, Florida. This delightful little community is located in the Florida Panhandle between Pensacola and Panama City, just 30 minutes north of the beautiful beaches of the Emerald Coast. The Director of Patient Care Services...


  • Saratoga Springs, United States Saratoga Hospital Full time

    The Clinical Coordinator collaborates with the Director on the governance and leadership of the Department providing high quality care in a patient focused environment. Responsibilities include ensuring appropriate staffing plans 24/7, staff developm Clinical, Coordinator, Director, Staffing, Relationship, Monitoring, Healthcare


  • Defuniak Springs, United States Lake Erie College of Osteopathic Medicine Full time

    Description JOB SUMMARY: We are recruiting an Assistant Director of Patient Care Services for LECOM's Dental Outreach Clinic in DeFuniak Springs, Florida. This delightful little community is located in the Florida Panhandle between Pensacola and Panama City, just 30 minutes north of the beautiful beaches of the Emerald Coast. The Assistant Director of...


  • Colorado Springs, United States CareerPhysician Full time

    The University of Colorado School of Medicine (CU Medicine) is pleased to announce a national search for a Medical Director to join the Department of Pediatrics, Section of Child Neurology. The clinical practice associated with this position will be based at the Children's Hospital Colorado – Colorado Springs (CHCO-COS) campus. The incoming Medical...


  • Ocean Springs, United States Singing River Health System Full time

    The Clinical Research Coordinator (CRC) is under the direct supervision of the Grants Program Director and supports the clinical research process according to federal regulations and standard operating procedures approved by the Regional Cancer Cente Clinical Research, Research Coordinator, Clinical, Program Director, Coordinator, Research, Banking,...

  • Supervisory Physician

    10 hours ago


    Warm Springs, United States Indian Health Service Full time

    Locations: Warm Springs, OR Type:Federal Salary Range:Per Year Open Period:4/26/2024 to 12/31/2024 Summary:To qualify for this position, your resume must state sufficient experience and/or education, to perform the duties of the specific position for which you are applying. Experience refers to paid and unpaid experience, including volunteer work done...

  • Director of Nursing

    1 week ago


    Palm Springs, United States SimiTree Talent Solutions Full time

    Director of Nursing - Home Health If you are an experienced Director of Patient Care Services / DOPCS, Director of Clinical Services / DOCS or Clinical Supervisor, or Clinical Manager with Home Care experience, then you need to read on... Director of Nursing Opportunity Description   Our client is a well-established Home Health organization. They have...

  • Director of Nursing

    13 hours ago


    Palm Springs, United States SimiTree Talent Solutions Full time

    Director of Nursing - Home Health If you are an experienced Director of Patient Care Services / DOPCS, Director of Clinical Services / DOCS or Clinical Supervisor, or Clinical Manager with Home Care experience, then you need to read on... Director of Nursing Opportunity Description   Our client is a well-established Home Health organization. They have...

  • Medical Director, Child Neurology

    Found in: Jooble US O C2 - 2 weeks ago


    Colorado Springs, CO, United States CareerPhysician Full time

    The University of Colorado School of Medicine (CU Medicine) is pleased to announce a national search for a Medical Director to join the Department of Pediatrics, Section of Child Neurology. The clinical practice associated with this position will be based at the Children's Hospital Colorado – Colorado Springs (CHCO-COS) campus. The incoming Medical...