• Director of Clinical Development

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(11/29/2018 8:19 AM)
    ID
    2018-2186
    Company
    Kashiv Pharma LLC
  • Overview

    Kashiv Pharma, LLC is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

     

    Summary:

     

    Provides Strategic and Operational Leadership of clinical research studies to ensure delivery on time, within Budget and high quality in compliance with ICH-GCP, Regulatory Authorities, guidelines and applicable SOPs. Responsibilities include Clinical study monitoring, Preparation of SOPs, Providing inputs on study designs, operational directions of one or more cross functional study teams, and quality oversight of one or more Clinical sites/SMOs/Specialty CROs. Responsibilities involve combination of execution and oversight to ensure deliverables. Develop and Maintain collaborative relationship with internal teams including Clinical Operational teams, Project Management teams and affiliates external partners including specialty CROs, SMOs, Clinical Sites, Principal Investigators, Academic Research Organizations and other clinical service providers.

    Responsibilities

    • Set strategy for effective operational management of clinical studies
    • Preparation of SOPs pertaining to Clinical Operations and facility to function in compliance to regulatory requirements
    • Identify Networking Clinical sites to execute Clinical studies in various therapeutic categories
    • Conducting feasibilities for the study enquiries and prepare budgets for bidding
    • Oversee Site selection, Site initiation, Site monitoring, Site closeout activities
    • Develop and allocate resource for monitoring of Clinical Phase and Managing the entire study according to Clinical Operation and monitoring plan
    • Review Study Designs, Protocol, Informed Consent Forms, Case Report Forms, Study related SOPs and Clinical Study reports as needed to provide inputs
    • Provide inputs for Clinical Study Reports and relevant sections of pre-IND briefing documents, INDs, NDAs and other documents intended for regulatory submission
    • Conduct selection and/or audit ongoing vendors viz. specialty CROs, SMOs, clinical central laboratories, shipment agencies, Bioanalytical Laboratories etc
    • Manage Cross functional teams and coordinate with various investigators, Investigator site personnel, Bioanalytical research personnel/site and Biostatistician to execute clinical studies, query management and finalize project reports
    • Scheduling the entire study logistics, Staffing and defining the activities for each study personnel in line with organizational policy
    • Provide Training and Monitor Patient enrolment, Patient eligibility and clinical conduct ensuring their compliance to approved protocol, ICH-GCP, in house SOP and applicable regulatory authorities
    • Ensure effective Clinical Management and Clinical Trial supplies management (IMPs, Diagnostic kits as applicable, vials, labels, documents etc)
    • Supervision of Clinical Research Associates, Clinical Coordinators, Project Managers Medical writing team on site and off site
    • Serve as an operational resource for internal team members for expedited problem identification and resolution, provision of project-specific updates, and team interactions and deadlines
    • Coordinate or manage multiple projects across the Health System
    • Problem solving at a strategic level, working with others to reach a resolution and manage pressure ensuring tasks are prioritized to meet the goals
    • Develop operational budget and tracking
    • Update Management periodically on the progress of studies and report on performance against plan
    • Forecasting monthly revenues based on the progress of studies and their milestones
    • Development of relationships including interactions with corporate partners, Investigators etc
    • Partner with the Management by understanding and interpreting business requirements, mapping process models, designing technical solutions to satisfy requirements, and completing formal system piloting
    • Negotiate and manage the budget and payments for the Investigational sites
    • Ensure Patient enrolment rate is maintained throughout the sites with possible backup plans
    • Automation of Clinical activities ensuring CFR part 11 compliance
    • Allocate appropriate resource within the department and track their progress thereby meeting the department targets
    • Ensure provision of timely, efficient, high quality clinical trial deliverables for clinical project or study
    • Provide strategic and managerial oversight of all functions during execution of Clinical studies
    • Assist Business Development team during technical discussion with client and provide Clinical feasibility
    • Performs other functions as required or assigned
    • Complies with all company policies and standards

     

    Qualifications

    • Clinical Trial Project Management Skills
    • Financial Budgeting and Forecasting skills
    • Leadership skills and Effective communication
    • In depth knowledge of ICH-GCP, regulatory guidelines, clinical research processes
    • Ability to effectively lead and direct global cross function team
    • Computer skills- Requirement of MS applications
    • Study Tools including electronic system skills- CTMS, EDC etc

     Education/experience/Licensing:

    • Minimum bachelor degree in science, preferably advance degree in Biologic/Scientific discipline.
    • 10 plus years of CRO/Pharmaceutical/Biotech experience overseeing clinical study execution

     Communication and other Skills:

    • Excellent oral and written communication skills to influence, inform, or guide others
    • Excellent team building, conflict resolution, sense of urgency, and a strong work ethic
    • Results and goal oriented with willingness to roll up sleeves to achieve goals
    • Creative, strategic, flexible, and able to think out of the box
    • Demonstrated ability to plan projects and follow through to completion is required.

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