While at PharmSci360, you can reach out to Harpreet Sandhu at (631)456-2218.
If you would like to directly speak with our recruiter, Paul Beran, he can be reached at Paulb@kashivpharma.com or (908)895-1539.
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.
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.
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
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
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
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.
About Kashiv Pharma
The company’s mission is to develop the next generation drug delivery platforms, and apply these proprietary technologies to create a portfolio of improved versions of known medicines with meaningful clinical differentiation and a compelling value proposition for patients, physicians, and payers. Kashiv intends to utilize the accelerated regulatory approval process to bring these improved drugs to market faster and more efficiently.
Kashiv aspires to become a world-class premier drug delivery, development, and specialty pharmaceutical company with a portfolio of improved medicines through the use of cutting-edge innovation, proprietary platform technologies, and strategic partnerships throughout the industry.