Clinical Pharmacology Senior Scientist (Remote)

Vertex

Boston Massachusetts

United States

Scientific Research
(No Timezone Provided)

Job Description

GENERAL POSITION SUMMARY:

Sr Clinical Pharmacologist manages scientific and operational aspects at a study level and assists development at a program level. He/she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans. The candidate will have expertise in clinical pharmacology concepts and applications. He/She will have the ability to effectively communicate, both in verbal and written form.

KEY RESPONSIBILITIES:

  • Representation for clinical pharmacology on at a program level and oversee all study-related activities 
  • Contribute to clinical pharmacology plans including drug-drug interaction, special population and safety studies
  • Generate hypothesis and provide strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations collaborating closely with cross functional colleagues
  • Create protocol concepts and guide protocol start-up including site initiations
  • Participate in study teams, oversee study progression including protocol conduct, data analyses, internal decision points and final reporting
  • Lead management of studies outsourced to contract research organization
  • Co-lead or serve on cross-functional committees and/or contribute to or lead departmental initiatives
  • Collaborate with other functions to guide program deliverables
  • Contribute to clinical pharmacology summary documents
  • Perform advanced/complex PK and PK/PD or exploratory analyses or guide such analyses as appropriate
  • Guide and/or assist with PK/PD modeling or simulations
  • Prepare technical reports including clinical study reports
  • Maintain a high standard for good clinical practice, compliance and ethics
  • Lead and contribute toward publications and abstracts
  • PREFERRED EDUCATION REQUIRED SKILLS:

  • Minimum education and experience requirements: Ph.D., MD/ PhD or PharmD in a related field, with minimum of 3 years of industry or regulatory agency experience; M.S. in a related field with minimum of 8 years of industry or regulatory agency experience
  • Critical thinking skills, with keen scientific judgment
  • Supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability
  • Provide support for other studies such as first-in-human, proof-of-concept or registrational studies
  • Supervise or conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses
  • Provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
  • Ensure close collaboration of Clinical Pharmacology with Modeling and Simulation
  • Clinical Pharmacology Senior Scientist (Remote)

    Vertex

    Boston Massachusetts

    United States

    Scientific Research

    (No Timezone Provided)

    Job Description

    GENERAL POSITION SUMMARY:

    Sr Clinical Pharmacologist manages scientific and operational aspects at a study level and assists development at a program level. He/she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans. The candidate will have expertise in clinical pharmacology concepts and applications. He/She will have the ability to effectively communicate, both in verbal and written form.

    KEY RESPONSIBILITIES:

  • Representation for clinical pharmacology on at a program level and oversee all study-related activities 
  • Contribute to clinical pharmacology plans including drug-drug interaction, special population and safety studies
  • Generate hypothesis and provide strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations collaborating closely with cross functional colleagues
  • Create protocol concepts and guide protocol start-up including site initiations
  • Participate in study teams, oversee study progression including protocol conduct, data analyses, internal decision points and final reporting
  • Lead management of studies outsourced to contract research organization
  • Co-lead or serve on cross-functional committees and/or contribute to or lead departmental initiatives
  • Collaborate with other functions to guide program deliverables
  • Contribute to clinical pharmacology summary documents
  • Perform advanced/complex PK and PK/PD or exploratory analyses or guide such analyses as appropriate
  • Guide and/or assist with PK/PD modeling or simulations
  • Prepare technical reports including clinical study reports
  • Maintain a high standard for good clinical practice, compliance and ethics
  • Lead and contribute toward publications and abstracts
  • PREFERRED EDUCATION REQUIRED SKILLS:

  • Minimum education and experience requirements: Ph.D., MD/ PhD or PharmD in a related field, with minimum of 3 years of industry or regulatory agency experience; M.S. in a related field with minimum of 8 years of industry or regulatory agency experience
  • Critical thinking skills, with keen scientific judgment
  • Supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability
  • Provide support for other studies such as first-in-human, proof-of-concept or registrational studies
  • Supervise or conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses
  • Provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
  • Ensure close collaboration of Clinical Pharmacology with Modeling and Simulation