West-Ward Pharmaceuticals Clinical Research Manager in Columbus, Ohio
Supports the Medical team by managing clinical endpoint, pharmacokinetic and in vitro studies required for filing new and on-going ANDA products. This includes development of strategic risk based approaches for FDA bioequivalence requirements, determination of appropriate study design, CRO/study budget management, and review/development of relevant modules/documents to ensure filings meet all current regulatory requirements. The CRM will provide medical input to the Research and Development Teams and other teams within the organization.
Determines appropriate strategic study designs based on pharmacokinetic and/or clinical knowledge of drug products and applicable regulatory requirements.
Obtains competitive bids from CROs with expertise in study requirements, selects CRO, develops or works with CRO/consultants to develop study protocol and other study related documents, ensures all elements are in place for study to run successfully.
Independently manages studies including pharmacokinetic studies (single and multiple-dose) in healthy subjects or patients, in vitro studies, clinical endpoint studies and post-marketing studies. These studies may be conducted both in the U.S. and internationally.
Manages day to day activities of CRO to ensure data meets quality standards and study timelines are met. Ensures studies comply with all requirements, such as WIs, SOPs, and GCP’s. Leads critical review of all study related documents.
Participates and serves as the medical team member in Research and Development Team meeting discussions. Provides input on study requirements to help ensure successful completion of bioequivalence requirements for filing.
Follows latest FDA guidance documents and seeks input from FDA when needed to determine most appropriate path forward for project. Attends relevant conferences/workshops. Communicate with FDA when needed regarding regulatory path for product.
Provides clinical input as needed to drug labeling, REMS programs, product development and other groups within the organization to support lifecycle and new filing activities.
Monitors CROs to ensure compliance with regulatory and ICH requirements and for competitiveness of study costs. Identify and evaluate new analytical and clinical CRO's that can support the business.
Responsible for reviewing and ensuring completeness of study data and final reports. Ensures appropriate completion of relevant medical sections of (A)NDAs and INDs (when applicable).
Responds to FDA deficiencies and questions as required.
Responsible for developing and submitting briefing packets with proposed clinical development plans, clinical study protocols, informed consent documents, etc. during development of products for FDA review/discussion.
Master’s degree in pharmaceutical or related sciences with a minimum of 4 years relevant experience in conducting clinical studies.
PharmD or PhD with a minimum of 1 year of relevant experience in conducting clinical studies is preferred.
Expert knowledge of conducting clinical studies in accordance with of applicable laws and regulations including GCP, ICH, DEA, FDA Guidances, ANDA Filing requirements, etc.
Experience in conducting studies for development of generic products is strongly preferred.
Previous Project Management experience managing and leading project and/or process improvement teams at a high level required.
Must be able to travel domestically and internationally as needed.
Ability to appropriately communicate with team members, internal customers, and suppliers to complete assigned duties as appropriate for the needs of the audience. Proficient ability to facilitate effective meetings and influence outcomes. Communication must be appropriate, timely, and accurate. Proficient ability to communicate effectively in writing, including technical documents. Proficient ability to generate and deliver formal technical presentations to team members and internal/external customers.
Possess the skills and knowledge to be able to work independently with no direct supervision.
Must demonstrate critical thinking skills. Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
External Company Name: West-Ward Pharmaceuticals
External Company URL: west-ward.com