Senior Pharmacokinetics Expert

3 weeks ago

Boston, Massachusetts, United States KP Recruiting Group Full time
Senior Pharmacokinetics Expert - Drug Development and Regulation

At KP Recruiting Group, we are seeking a highly skilled Senior Pharmacokinetics Expert to join our team. This is a confidential role that we are excited to present to a qualified candidate.

Our client offers a hybrid work schedule with 23 days a week in-office, providing a great work-life balance. As a Senior Pharmacokinetics Expert, you will be responsible for generating, integrating, and leveraging clinical and nonclinical PK/PD and metabolism knowledge to support critical decision-making and risk management for projects from first-in-human dosing through life cycle management.

The Pharmacokinetics Dynamics and Metabolism (PKDM) department at our client contributes to the safe and effective treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process where possible. As such, you will aid in dose selection/study design, derisking of drug-drug interactions, benefit/risk assessment, and formulation development with the use of Population PK/PD and PBPK approaches as appropriate, and contribute to regulatory submissions/interactions.

You will serve as a PKDM representative on project teams and work in close collaboration with multidisciplinary teams to progress drug candidates from IND through early phase/late phase to successful approval. Your responsibilities will include the design, planning, and oversight of relevant studies, as well as PK/PD analysis interpretation and reporting of results from molecules/compounds in clinical stage.

You will apply quantitative methods via modeling and simulation to provide dose selection and complex issue resolution at various stages of drug development. Additionally, you will be responsible for clinical pharmacology contributions to regulatory documents and inquiries. You will interface with Research and work closely with discovery research during the pre-IND stages of drug development to ensure sufficient PK/PD knowledge exists for translation to the clinic.

Key Requirements
  • An earned Ph.D. degree in clinical pharmacology, pharmacokinetics, pharmacometrics, mathematics, engineering, computational biology, or a related field is required, with or without postdoctoral experience plus 5 years of relevant experience, OR an MS/MA degree in fields listed above plus at least 12 years of relevant experience, OR a BS/BA degree in fields listed above plus at least 14 years of relevant experience.
  • A minimum of 5 years of experience in clinical PK/PD, pharmacometrics, and/or clinical pharmacology is required.
  • Proficiency in PK modeling software/platforms is required.
  • Effective communication and interpersonal skills are required.
  • Strong presentation skills are required.
Benefits
  • 401(k) matching
  • Family and individual insurance packages (health, life, dental, and vision)
  • Paid time off and paid holidays
  • Long and short-term disability
  • Identity theft plans
  • Retirement and pension plans
  • Employee assistance program
  • Employee referral program
  • Tuition reimbursement programs
  • Advancement and professional growth opportunities
  • Parental leave
  • More

The estimated salary for this role is $110,000 - $140,000 per year, based on the title, job description, and location. If you are a motivated and experienced Senior Pharmacokinetics Expert looking for a new challenge, please submit your application for consideration.

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