Boston Biomedical, Inc. is seeking a versatile and experienced Director level scientist with strengths in clinical pharmacology, and a working knowledge of drug metabolism and bioanalytic chemistry.
Executive Director and Head, Clinical Pharmacology and Drug Metabolism
- Represent the clinical pharmacology and drug metabolism department, provide PK, PK/PD, clinical pharmacology and drug-metabolism expertise to project teams.
- Design clinical pharmacology components of clinical studies.
- Create clinical pharmacology drug-development plans.
- Analyze and interpret clinical pharmacology data.
- Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data.
- Analyze and interpret drug metabolism and ADME data.
- Conduct bottom-up (ie; PBPK) and top-down (ie; nonlinear mixed effects) modeling.
- Direct activities of contract research laboratories (CROs), including metabolism and bioanalytic activities and assuring GxP compliance.
- 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) non-clinical drug metabolism, 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 and Drug Metabolism department.
- Exhibit versatility in accordance with the ebbs and flow of shifting needs in accordance with the various stages of the drug development efforts.
Professional Experience / Qualifications
- Demonstrated expertise in clinical pharmacology; clinical pharmacology program plan, study design, methods, data interpretation, implications, and reporting.
- Knowledgeable in pre-clinical assessment methods and resultant data interpretation (ex: microsomes, hepatocytes, CACO2 systems).
- Ability to work in a cross-functional environment.
- Skilled in the use of pharmacokinetics software, a modeling platform, and a programing language enabling data manipulation, statistical analyses, and graphics is desirable. Examples include; Phoenix WinNonlin, Simcyp, GastroPlus, PK-Sim, PhysioDesigner, JMP, R (or S-plus), SAS, Stella, Berkeley Madonna, Prism GraphPad, Excel, NONMEM.
- Demonstrated knowledgeability of bioanalytic chemistry.
- Excellent verbal and written communication skills in English.
PhDin pharmacokinetics, clinical pharmacology, biology, biochemistry, or a related discipline with 9-plus yearsexperience 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
Domestic and international travel for face-to-face interaction with regulatory authorities, vendors, CROs, study sites, other Sumitomo Dainippon sites, and conferences may be required.
Please send resumes to email@example.com