Associate Director of Clinical Pharmacology
Company: AnaptysBio Inc
Location: San Diego
Posted on: April 26, 2024
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Job Description:
AnaptysBio IncAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.Description:Position
SummaryThis position is a key member of the development team,
executing clinical drug development activities by evaluating the
clinical pharmacology of antibody therapeutics in an excellent
organization that focused primarily, but not exclusively, on
immune-inflammatory diseases. This position reports to the head of
clinical pharmacology and toxicology and liaises with clinical
development, clinical operations, non-clinical pharmacology and
toxicology, and drug discovery to execute activities for advancing
the development pipeline. Essential FunctionsParticipate in the
design of clinical pharmacology strategy and studies to support
clinical development programs Contribute clinical pharmacology
sections of clinical study protocols and reports and regulatory
documents including Investigator Brochures, and
NDA/BLA/IMPDsConduct hands-on non-clinical and clinical data
analysis, including non-compartmental, PK/PD and modeling analyses
where applicableOversees the development and validation of
quantitative in vivo assays to enable PK/PD characterization of
therapeutic antibodiesWork with nonclinical Pharmacology and
Toxicology to design, analyze and interpret toxicokinetic and
immnunogenicity dataCollaborate with the clinical operations,
clinical development, biostatistics/data sciences, and
cross-functional project teamsWork closely with bioanalysis CROs to
ensure that all studies are performed in high quality and timely
manner to meet program milestones and goalsWork with Clinical
Operations to ensure clinical PK/ADA/Biomarker samples are well
managedReview clinical study protocols to ensure PK, ADA and
Biomarker sampling time points are consistent with study design
Manage CRO activities and ensure Good Laboratory Practice (GLP) and
Good Clinical Practice (GCP) compliance Identify, scope out and
select new clinical pharmacology/bioanalysis vendors as neededWork
with internal legal and finance to execute service contracts with
CRO labsPossesses excellent communication skills to work
efficiently with all stakeholdersRequirements:QualificationsPhD,
PharmD or equivalent in Pharmacokinetics, Pharmacology,
Bioanalytical or related field with at least 5+ years of experience
in Clinical Pharmacology, DMPK or related disciplines required.
Knowledge and Competencies: Knowledge of pharmacokinetics and
pharmacodynamics (PK/PD) and DMPK principlesFamiliarity with
regulatory guidelines such as ICH, GLP and GCPsWorking knowledge of
clinical pharmacology related software tools such as WinNonlin,
NONMEM, SympCyp and/or RKnowledge of large-molecule bioanalytical
assays used to support PK studiesExperience and knowledge in
translational methodologies to advance molecules from preclinical
to first-in-human studiesKnowledge of quantitative pharmacology,
modeling and simulation or advanced data analysisExcellent team
skills and proven ability to work within multi-disciplinary teams
to influence the overall direction of projectsStrong ability to
prioritize daily work based on changing business
requirementsExcellent ability to multi-task in a high-energy,
dynamic environmentSelf-motivated, independent, and
results-oriented Ability to work productively in a matrix
environment, as a team contributor taking ownership of multiple
projectsPhysical DemandsThe physical demands described here are
representative of those that must be met by an employee to
successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.While performing
the duties of this job, the employee is regularly required to sit
and talk or hear. The employee frequently is required to use hands
to finger, handle, or feel. The employee is occasionally required
to stand, walk, and reach with hands and arms. The employee must
occasionally lift and/or move up to 10 pounds. Specific vision
abilities required by this job include close vision and ability to
adjust focus in order to read.Work EnvironmentThe work environment
characteristics are representative of those an employee encounters
while performing the essential functions of this job, typically in
an open office environment. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions.The noise level in the work environment is usually
moderate.May be required to travel by plane or carThis position
requires working with biological and/or chemical hazards All
qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.Compensation details: 150000-190000 Yearly
SalaryPI495c569b0795-25660-33514589
Keywords: AnaptysBio Inc, San Diego , Associate Director of Clinical Pharmacology, Executive , San Diego, California
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