High Priority Position : Director Clinical Pharmacology at Cambridge, MA (REMOTE Until COVID)
Babu S
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Director Clinical Pharmacology
Location: Cambridge, MA (REMOTE Until COVID)
Start: 04/04/2022
End: 03/31/2023
Description:
Department: Clinical Development(Cam)
Job Category: Clinical
Duties: Client seeking a versatile and experienced Director level scientist with strengths in clinical pharmacology, and a working knowledge of drug metabolism and bioanalytic chemistry.
Represent the clinical pharmacology and drug metabolism department, provide PK, PK/PD, clinical pharmacology and drug-metabolism expertise to project teams.
o Design clinical pharmacology components of clinical studies.
o Create clinical pharmacology drug-development plans as required.
o Analyze and interpret clinical pharmacology data.
o Interact with pre-clinical scientists in analyzing and interpreting drug metabolism and pharmacologic data.
o Analyze and interpret drug metabolism and ADME data.
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 based on information received from bioanalytic laboratories, pharmacokinetic (PK) sample logistics, and site initiation activities (in synchrony with Clinical Operations).
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.
Other duties as needed.
Skills:
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.
Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others.
This is a remote role and all candidates must be vaccinated against Covid-19
Keywords:
Education:
PhD in pharmacokinetics, clinical pharmacology, biology, biochemistry, or a related discipline with 9-plus years' experience in drug development.
Experience in oncology drug development is a strong plus, but not required.
Required Skills:
CLINICAL ASSESSMENT
CLINICAL OPERATIONS
CLINICAL PHARMACOLOGY
CLINICAL STUDIES
CHEMISTRY
Additional Skills:
EXCELLENT VERBAL AND WRITTEN COMMUNICATION SKILLS
FDA
GXP
JMP
LOGISTICS
METABOLISM
NDA
OPERATIONS
PHARMACOKINETIC
PHARMACOKINETICS
PHARMACOLOGY
PRE-CLINICAL
SAS
ADME
BIOCHEMISTRY
DIRECTOR LEVEL
MICROSOFT EXCEL
ONCOLOGY
SERIAL ATTACHED SCSI
TOXICOLOGY
CLINICAL STUDY
DATA MANIPULATION
DRUG DEVELOPMENT
DRUG METABOLISM
EXCEL
Please Note:
If for any reason this does not interest you or you felt uncomfortable by any part of this email, I sincerely apologize. Please consider this E-mail as a request for referrals and feel free in forward this email to anyone whom you might find a fit.