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Alpine Immune Sciences
Seattle, Or Remote, United States
6 days ago

Description

Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

The (Assoc/Sr) Director, Clinical Pharmacology supports an expanding clinical portfolio of biologic therapeutics.  Responsible for dose regimen selection, including conduction and/or supervision of PK/PD analyses, as well as clinical pharmacology strategic and tactical aspects.



Requirements

Key Responsibilities
 
·         Represent Clinical Pharmacology and provide PKPD input to project teams.
·         Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
·         Conduct PK/PD analyses to guide development decisions on project teams
·         Develop model-based dose selection approach for pivotal clinical trials, while working in close partnership with (potentially external) pharmacometrics, clinicians and statisticians.
·         May partner with preclinical functions to understand and interpret preclinical findings and their translation to clinical development on individual development programs as well as broader technology platform research initiatives. 
·         Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
·         Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials) to generate high quality and relevant data.
·         Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues.
·         Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
·         Participates in the preparation of abstracts and manuscripts for publication
·         Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Program Management, and other R&D functions.
 
Qualifications
 
·         Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with extensive experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience with 5+ years of industry experience.
·         Strong working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
·         Proficient in using R, Phoenix WinNonlin, NONMEM, or other pharmacokinetic and modeling software.
·         Strong communication skills (verbal and written) and presentation skills are required.  Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.

Job Information

  • Job ID: 60098677
  • Location:
    Seattle, Or Remote, United States
  • Company Name: Alpine Immune Sciences
  • Position Title: (Assoc/Sr) Director, Clinical Pharmacology
  • Job Function: Pharmacologist
  • Setting: Biotechnology Company
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: 5-7 Years
  • Required Travel: 0-10%
Biotechnology
Seattle , WA , US

Please refer to the company's website or job descriptions to learn more about them.

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