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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