Duration: 6 months to start
Description:
The client has an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join their team supporting CNS therapeutic area as a key member of their department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
This position will have a core scientific responsibility of selecting optimal doses and dosage regimens inpatients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable.
Essential Areas of Responsibility:
- Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
- Conducting and overseeing pharmacokinetic (NCA)analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions
- Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
- Ability to function in a highly matrixed team environment
- A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills are essential in this dynamic role.
- Clinical pharmacology experience with small molecule in a variety of clinical investigation paradigms is desired.
- Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes. Knowledge of, and immediate experience in CNS therapeutics is desired.
- The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members.
- Upon completion of on-boarding, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.
Requirements:
- Education: Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
- PK Experience: The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
- Knowledge: Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
- Programming experience (Phoenix) is must; other programming experience (e.g., , Monolix, R, WinNonlin, SAS, Splus) is desirable.
- Regulatory: Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Writing: Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (e.g.: INDs, NDAs, CTDs) is required.
- Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
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