CSL Plasma Inc. | Director Clinical Pharmacology | chihuahua

hace 2 semanas

chihuahua, México CSL Plasma Inc. A tiempo completo

Director Clinical Pharmacology

Apply locations Americas, US-PA, King of Prussia, CSL Behring time type Full time posted on Posted 2 Days Ago job requisition id R-247446

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Director Clinical Pharmacology? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Executive Director, Clinical Pharmacology.

You are responsible for clinical pharmacology matters for a range of projects spanning the CSL R&D portfolio. You will be independent in a matrix team-aligned in the fulfillment of Clinical Pharmacology responsibilities. This includes leading a program's clinical pharmacology & pharmacometrics strategy, ensuring coverage and integrated delivery of all pharmacokinetic and modeling and simulation aspects, and the design of clinical pharmacology studies for multiple programs. Also, your role will involve important written/oral ClinPharm/ Pharmacometric interactions with regulatory authorities, writing of clinical pharmacology sections in the dossiers and answering questions in connection with submission procedures.

Main Responsibilities and Accountabilities

  • Lead, with a high degree of independence, the clinical pharmacology and PK-PD strategy for portfolio programs, working together with the Pharmacometrician, Clinical Program Director, Clinical scientists, Biostatisticians, and other CDT colleagues.
  • Lead the design of clinical pharmacology studies or protocol sections throughout all stages of drug development and provide oversight for implementation of such studies together with Clinical Development, Clinical Safety and Clinical Research Operations.
  • Plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and PK-PD analysis.
  • Lead the high-quality review and interpretation of clinical pharmacology study results and oversee the presentation and writing thereof in clinical study reports, publications and related study documentation.
  • Independently provide clinical pharmacology & pharmacometrics representation on clinical development matrix teams, ensuring agreement and integration of the clinical pharmacology strategy within the global development plan.
  • Independently implement the use of analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to support study designs, throughout an assigned clinical development program.
  • Provide clinical pharmacology contributions to protocols, regulatory documents including Investigator Brochures, Submissions, Labeling and those required for face-to-face attendance at regulatory meetings and regulatory filings. Provide resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in setting strategy to and writing responses.
  • Provide support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy and using Pharm-Tox data in the development of early clinical studies.

Position Qualifications and Experience Requirements

  • PhD or PharmD. Clinical pharmacology research fellowship favorable and experience in a clinical pharmacology discipline (e.g., PK-PD).
  • 10+ years experience specifically contributing to the clinical pharmacology aspects of clinical drug development.
  • Experience with general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK-PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development.
  • Technical ability in pharmacometrics methodology and application.

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off
#J-18808-Ljbffr

  • Senior Clinical Pharmacology Leader

    hace 2 semanas

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    About the RoleCsl Plasma Inc. is seeking a highly experienced Senior Clinical Pharmacology Leader to join our team in King of Prussia, PA. As a key member of our Clinical Development Team, you will be responsible for leading the clinical pharmacology strategy for multiple programs within our R&D portfolio.Key ResponsibilitiesLeverage your expertise in...

  • CSL Plasma Inc. | Center Medical Director

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Center Medical Director (CMD) Apply locations: Americas, US-TN, Jackson 257, CSL Plasma Time type: Part time Posted on: Posted 30+ Days Ago Job requisition id: R-194954 Responsibilities Plasma Operations:Provides operational initiatives with the goal of aligning center processes, improving operational efficiencies to ensure center development and ultimately...

  • CSL Plasma Inc. | Plasma Processing Technician | chihuahua

    hace 5 días

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Plasma Processing Technician Apply locations: Americas, US-AR, SpringdaleTime type: Full timePosted on: Posted 30+ Days AgoJob requisition id: R-205229 Responsibilities: Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations....

  • CSL Plasma Inc. | Plasma Processing Technician | chihuahua

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Plasma Processing Technician Apply locations: Americas, US-WV, Parkersburg 178, CSL Plasma Time type: Part time Posted on: Posted 2 Days Ago Time left to apply: End Date: February 28, 2025 (30+ days left to apply) Job requisition id: R-247392 The Opportunity Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected...

  • CSL Plasma Inc. | Contract Center Medical Director/Center Physician | chihuahua

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Contract Center Medical Director/Center Physician Apply locations Americas, US-OH, Akron 402, CSL Plasma time type Part time posted on Posted 30+ Days Ago job requisition id R-076769 Job Description Summary Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the...

  • Medical Director

    hace 24 horas

    Chihuahua, Chihuahua, México CSL Plasma Inc. A tiempo completo

    Job OverviewCSL Plasma Inc. is seeking a highly skilled Medical Director to lead our blood plasma operations in the Americas region. This is a full-time position that requires strong leadership and medical expertise.

  • CSL Plasma Inc. | Contract Center Medical Director/Center Physician

    hace 3 días

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Contract Center Medical Director/Center Physician Apply locations Americas, US-RI, East Providence 202, CSL Plasma time type Full time posted on Posted 30+ Days Ago job requisition id R-064118 Serves as the primary physician for reporting to the Food and Drug Administration and provides medical oversight in compliance with applicable Federal and State...

  • CSL Plasma Inc. | Posting title Contract Center Medical Director/Center Physician | chihuahua

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Posting title Contract Center Medical Director/Center Physician Apply locations Americas, US-AL, Birmingham 259, CSL Plasma time type Full time posted on Posted 30+ Days Ago job requisition id R-081018 Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with...

  • CSL Plasma Inc. | Center Medical Director

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Center Medical Director (CMD)/Center Physician (CP) - Contractor Apply locations Americas, US-MO, Springfield 620, CSL Plasma time type Full time posted on Posted 30+ Days Ago job requisition id R-063034 Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with...

  • CSL Plasma Inc. | Center Medical Director

    hace 5 días

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Center Medical Director (CMD) Apply locations Americas, US-AR, Little Rock234, CSL Plasma time type Part time posted on Posted 30+ Days Ago job requisition id R-089734 Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations...

  • Senior Medical Director

    hace 2 semanas

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    Job Summary">The Senior Medical Director - Plasma Center will serve as the primary physician for reporting to the Food and Drug Administration (FDA) and provide medical oversight in compliance with applicable Federal and State regulations. This individual will ensure that CSL Plasma Services policies and procedures are adhered to, maintain high medical...

  • Clinical Care Specialist

    hace 7 horas

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    Overview: At Csl Plasma Inc., we are dedicated to helping individuals with rare and serious diseases live normal, healthy lives by collecting human plasma. As a Clinical Care Specialist, you will play a vital role in ensuring the safety and well-being of our donors.About the Role: We offer an estimated annual salary of $104,000-$109,200 based on a 40-hour...

  • Highly Qualified Plasma Processing Specialist

    hace 8 horas

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    Company OverviewCsl Plasma Inc. is a leading collector of human plasma dedicated to helping people with rare and serious diseases live normal, healthy lives.SalaryWe offer an attractive compensation package, including an estimated $55,000 - $70,000 per year, depending on experience and qualifications.Job DescriptionAs a Plasma Processing Technician at Csl...

  • CSL Plasma Inc. | Director, US Price Strategy | chihuahua

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Director, US Price Strategy Apply locations Americas, US-PA, King of Prussia, CSL Behring time type Full time posted on Posted 3 Days Ago job requisition id R-246910 The Director, US Price Strategy will lead the development and execution of pricing strategies across the CSLB US portfolio of products to support value optimizing access to CSL Behring’s...

  • CSL Plasma Inc. | Director, Integration Platforms | chihuahua

    hace 3 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Director, Integration Platforms Apply locations Americas, US-PA, King of Prussia, CSL Behring EMEA, CH, Kanton Bern, Bern, CSL Behring time type Full time posted on Posted 26 Days Ago job requisition id R-245889 The Opportunity Reporting to the Global Head of Enterprise Systems & Processes, you will play a strategic leadership role to strategize and...

  • Senior Director of Plasma Operations

    hace 4 semanas

    Chihuahua, Chihuahua, México CSL Plasma Inc. A tiempo completo

    OverviewCSL Plasma Inc. is a leading global plasma collection company, dedicated to helping patients with rare and serious diseases live normal, healthy lives.About the RoleWe are seeking an experienced Senior Director of Plasma Operations to join our team in the Americas region. As a key member of our leadership team, you will be responsible for overseeing...

  • Medical Plasma Specialist

    hace 2 días

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    About UsCsl Plasma Inc. is a leading global plasma collection company dedicated to improving the lives of individuals with rare and serious diseases.

  • Customer Service Representative

    hace 4 semanas

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    Job OverviewWe are seeking a highly skilled and customer-focused Customer Service Representative - Plasma Collection Specialist to join our team at CSL Plasma Inc.

  • CSL Plasma Inc. | Head of Lab Execution Systems, Senior Director

    hace 2 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Head of Lab Execution Systems, Senior Director (LES) Apply locations Americas, US-PA, King of Prussia, CSL Behring Americas, US-IL, Kankakee, CSL Behring APAC, AU, Broadmeadows, Seqirus EMEA, CH, Kanton Bern, Bern, CSL Behring APAC, AU, Victoria, Parkville, CSL Limited Melbourne time type Full time posted on Posted 16 Days Ago job requisition id R-245124 The...

  • CSL Plasma Inc. | Senior Manager, Global Medical Publications | chihuahua

    hace 2 semanas

    chihuahua, México CSL Plasma Inc. A tiempo completo

    Senior Manager, Global Medical Publications Apply locations: Americas, US-PA, King of Prussia, CSL Behring; EMEA, GB, West Sussex, Haywards Heath, CSL Behring; EMEA, CH, Kanton Bern, Bern, CSL Behring; APAC, AU, Victoria, Parkville, CSL Limited MelbourneTime type: Full timePosted on: Posted 3 Days AgoJob requisition id: R-247584 The position is responsible...