CLINICAL TRIALS PHARMACY JOBS - PHARMACIST JOBS IN CLINICAL TRIAL/DRUG INVESTIGATIONAL TRIALS
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Clinical Trials Pharmacist or Clinical Trials Drug Investigator

  • To qualify for this position you will need to have a PharmD, PhD (Fellowship in Clinical Pharmacology is highly desired). You will need to have two to four years of postgraduate clinical research experience (preferably early phase studies) is required. A strong scientific background in the biomedical sciences, and experience in both academic and industry early phase clinical trial design and conduct are required. You should also have a record of peer reviewed publications. And this role requires a strong background in clinical drug development.

    Additional Requirements Include:

    A demonstrable track record in creative, early clinical protocol development, utilizing pk, pd, modeling in both volunteers and patients.
    Ability to lead a group of clinical scientists to achieve high quality study design while achieving rapid turnaround on study conduct and trial data delivery.
    Broad based background in experimental models, methodology development, new technological applications.
    Broad based background in clinical pharmacology, drug metabolism and analytical methods.
    Experience in achieving goals across organizational boundaries.
    Experience in application and utilization of metrics to sit and achieve rapid timelines.
    Extensive experience in clinical report preparation, integration, and summary document preparation.
    Experience in dealing with regulatory agencies, and knowledge of GCP and ICH guidelines.

    In this role you will:

    Apply unique therapeutic area knowledge to the translation of clinical research ideas into well designed and executed clinical trials.
    Leads multidisciplinary study team to design, conduct, analyze and report experimental medicine and registration studies (for a compound or group of compounds in a given therapeutic area) and related    regulatory documents.
    Have overall accountability for content and execution of assigned studies.
    Coach and develop more junior CRSs.
    Work closely with ECL to define strategy for pharmacodynamic model and candidate development.
    Design Clinical Science (CS) studies and high quality analysis strategies, with input from other study team member, to meet study/project objectives.
    Author Clinical Science protocols which apply appropriate technologies, models and biomarkers to improve conical characterization of drug candidates.
    Manage the project and protocols level budget including cost projections and performance against budget.
    Work with study CRA to identify and evaluate study sites/CROs. Review and approve proposed study sites/investigators and CROs.
    Leads process improvement initiatives.
    Review emerging data from ongoing and completed studies. Initiate protocol amendments, as necessary, to address safety, PK and PD issues.
    Author integrated scientific report of clinical safety, PK, PD and pharmacogenetic data. Manage study reporting process to assure accuracy, scientific excellence and congruence of message between studies within a given project.
    Contribute to preparation of IND updates, IBs, regulatory responses and submissions.
     
     

 

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