Sumitomo Dainippon Pharma Oncology is seeking a versatile and experienced Associate Director/Director level scientist with strengths clinical pharmacology, pharmacometrics, a working knowledge of drug metabolism and bioanalytic chemistry, and developing clinical plans.
- Represent the Clinical Pharmacology and Drug Metabolism (CPDM) department providing clinical pharmacology, pharmacometrics, PK, PK/PD, and drug-metabolism expertise to project teams.
- Analyze and interpret clinical pharmacology/pharmacokinetic (PK) data using noncompartmental, modeling, and/or nonlinear mixed effects modeling (pharmacometrics) approaches as appropriate.
- Analyze and interpret drug metabolism and ADME data.
- Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data.
- Conduct bottom-up (ie; PBPK) modeling as appropriate.
- Direct activities of contract research laboratories (CROs), including metabolism and bioanalytic activities and assuring GxP compliance.
- Create clinical pharmacology drug-development plans.
- Author reports/chapters of reports including those intended for regulatory submission. For example, clinical study reports (CSRs), investigator brochures (IB), new drug application (NDA) common technical document (CTD), bioanalytic, and clinical pharmacology chapters, and alike.
- Support clinical protocols and protocol execution, including lab manual authoring, pharmacokinetic (PK) sample logistics, and site initiation activities.
- Collaborate with other line functions and all members of the Clinical Pharmacology department, sharing expertise with others in support of individual and departmental objectives and goals, and individual needs.
- Exhibit versatility in accordance with the ebbs and flow of shifting needs in accordance with the various stages of the drug development efforts.
- Other duties as assigned.
- Demonstrated expertise in clinical pharmacology, PK, pharmacometrics, data interpretation, and implications.
- Knowledgeable in bioanalytic chemistry.
- Knowledgeable in pre-clinical assessment methods and resultant data interpretation (ex: microsomes, hepatocytes, CACO2 systems) as applicable to PK.
- Ability to work in a cross-functional environment.
- Skilled in the use of pharmacokinetic analysis software, a modeling platform, and a programing language enabling data manipulation, statistical analyses, and graphics is desirable. Examples include Phoenix WinNonlin, Phoenix NLME, Simcyp, JMP, R, SAS, Stella, Berkeley Madonna, Prism GraphPad, Excel, NONMEM.
- Excellent verbal and written communication skills in English.
- PhD in clinical pharmacology, biology, biochemistry, drug metabolism or a related discipline with 10-plus years’ experience in drug development.
- Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others.
- Experience in oncology drug development is a strong plus, but not required.
Job Location: Cambridge, MA
Equal Opportunity Employer
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