Clinical Pharmacology Manager DMPK

4 days ago

Waltham, Massachusetts, United States Intellyk Full time

Job Description:

We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA 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). 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 modelling experience is desirable.

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.

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

Job Type: Contract

Pay: $ $80.00 per hour

Work Location: Hybrid remote in Waltham, MA 02451

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