Senior / Principal Scientist, Pharmacokinetics

Job Title: Senior / Principal Scientist, Pharmacokinetics

Job Number: 32342

Location: Remote, 

Job Description

Our client is is seeking a highly motivated and experienced Senior Scientist /  Principal Scientist of Pharmacokinetics. The incumbent will work collaboratively across nonclinical and clinical multidisciplinary teams to design and interpret pharmacokinetic and pharmacodynamic studies. This individual will closely collaborate with cross-functional colleagues/teams to develop data and model driven pharmacokinetic strategies that aid decision making on key development questions such as dose selection and trial design. The right candidate will be confident, passionate, execution-focused, team-oriented and has a “can-do” attitude and the ability to work collaboratively with others.

Hybrid / Remote Flexibility

Responsibilities

Responsibilities

• Scientific oversight of nonclinical and clinical pharmacokinetic studies of therapeutic antibodies including study design, data collection, analysis, and modeling

• Contribute to writing and review of PK, TK, PD and associated translational study reports in support of regulatory submissions.

• Provide quantitative clinical pharmacology expertise, working closely with clinical development team to optimize doses, dosage regimens and study designs throughout clinical drug development

• Oversee CRO selections, operational activities, build external consultant networks and set the right balance of internal versus external capabilities

• Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy

• Provide leadership in maintaining scientific awareness and presence in quantitative pharmacology and pharmacokinetic science, preparation of abstracts and manuscripts for publication

• Develop and implement pharmacokinetic model development efforts across clinical and nonclinical projects to support the translation of therapeutic monoclonal antibodies

• Identify opportunities where modeling and simulation can advance candidate drug selection and contribute to the understanding of pharmacological activity, efficacy, and safety

• Stay abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics, including internal SOPs and regulations in order to be a team resource for pharmacokinetic knowledge and applications

• Contribute to the development or improvement of our tools, processes, and methodologies, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia, and academic relationships.

Required Skills

Requirements

• PhD with strong quantitative skills (e.g., pharmacokinetics, mechanistic modeling/systems pharmacology, literature meta-analyses, clinical trial simulations, statistics)

• 8+ years of experience in the pharmaceutical or biotechnology industry

• Deep and broad experience in clinical and non-clinical drug development with in-depth expertise in therapeutic antibody development

• Experience using a nonlinear mixed effects modeling software platform (NONMEM, Monolix, Phoenix NLME, etc.) highly desirable

• Experience using R software desirable

• Excellent written, verbal communication and problem-solving skills

• A desire to learn new things, the ability to remain flexible in a dynamic work environment and adjust priorities in a timely manner.