Study Clinician (BBBH11448) La Jolla, California

The world's largest research-based pharmaceutical company is hiring! Our client discovers, develops, manufactures, and markets leading prescription medication.

For over 150 years, they have been making the world a healthier place to live.

The Non-MD/Study Clinician integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.

  • The Non-MD/Study Clinician is responsible for working collaboratively with the clinical leader, physician and members of the development team to establish the Clinical Development Plans for one or more compounds from lead development in Discovery to Phase I-II clinical trials and the BioSimilars compounds through registration.
  • The Non-MD/Study Clinician is responsible for developing methodologies to support proof of pharmacology, proof of mechanism, proof of concept and biosimilarity studies.
  • The Non-MD/Study Clinician provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations.
  • The Non-MD/Study Clinician actively participates in defining the key components of the clinical protocols.
  • Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation.
  • Responsible for clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, biosimilarity, medical device studies etc) from trial design (development of outline/core elements) through clinical review, oversight and reporting.
  • Responsible for final recommendations to clinical development plans for one or more compounds, including the review of pre-clinical package after seeking appropriate input, review and endorsement from key stakeholders for go no-go development decision criteria.
  • In collaboration with the clinical leader, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.
  • Lead efforts to author clinical sections of regulatory documents including the Investigator Brochure, Annual Reports, IND sections.
  • Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide – for Clinicians and SAF09 SOP.
  • Lead efforts with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s) at the study or compound level.
  • Acts as a liaison with internal groups including internal governance, commercial and external experts and potential regulators
  • Responds and contributes to novel study designs
  • Maintains a high degree of awareness of the external environment and ensures external innovations in scientific aspects and operational delivery are applied to the Research portfolio
  • Analyze emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality
  • Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in The Company’s success
  • Analyze emerging safety profile of the drug, keeping the physician clinician informed of changes in the safety profile as they occur in the assigned study(ies). Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
  • Involve in the transfer of novel techniques in partnership with other lines such as Development Operations so that they can be exported from specialized sites to in-house facilities or other investigators / vendors
    Skills: MS Excel: 7+ Years MS Outlook: 7+ Years MS Word: 7+ Years

    Approx. Duration: 2 years

    About Hired By Matrix

    For more than 25 years, Hired by Matrix has been providing temporary and long-term contract staffing solutions to Fortune 1,000 as well as mid-market companies nationwide. Our clients include major pharmaceutical, delivery & logistic, business information, financial and entertainment companies. The technology that we support is as diverse as our clients. We provide consultants with experience in mainframe legacy technology all the way to cutting edge technologies, like web and mobile application development. Our consultants are in roles that include Project Managers, Architects, Business analysts, QA, developers and infrastructure & network specialists. At the request of our clients we have broadened our capabilities across a variety of different areas, including: finance and accounting, R&D, clinical sciences and administrative. And as a woman-owned, WBENC-certified business we’ve helped companies grow their Supplier Diversity spend which is certainly a nice added benefit as well.

    Our extended network of qualified contract professionals offers nationwide contracting capabilities.

    Our dedicated team of account managers and recruiters collaborates closely with each of our clients to understand their staffing needs, corporate requirements and company cultures before building robust, fully customized pipelines of highly-qualified contract professionals in response.