Manager-Clinical PK

Scientific Search
Oct 13, 2016
Nov 10, 2016
Executive Search
Employer Type
Direct Employer
Employment Type
Full Time
Job Description:

The Manager, Clinical PK is responsible for leading the set-up, implementation, conduct, analysis and reporting of clinical trials for US and Global (Canada, EMEA & Innovative) projects. Defines the clinical trial strategy and management of BA/BE clinical studies. Responsible for the designing, planning and outsourcing of phase I-IV studies in support of our client's applications to Global regulatory agencies. Ensures that bioequivalence (BE) studies/clinical studies are conducted and data is generated, documented and reported in compliance with the study protocol, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), the Declaration of Helsinki and the applicable regulatory requirements in the country where the study is to be conducted. Provides administrative and logistical support, as required. Follows up on current guidance and regulatory requirements related to conduct of BE studies/clinical studies RESPONSIBILITIESAssist Senior Director, Clinical Research on developing scientific strategies for US and Global projectsLead designing, planning and outsourcing of phase I PK, IS, and PD bioequivalence studies in support of applications to regulatory agenciesReview of scientific literature to develop the study design and project strategyPropose clinical development plan and clinical requirements for new products.Select CROs, negotiate contracts, and maintain budgets and timelines.Supervision of the set-up, implementation, conduct, analysis and reporting of clinical trialsReview of protocols for IND and ANDA studiesReview and analyze clinical trial data, prepare scientific conclusion for study resultsEnsure compliance with the requirements of GCP, GLP and other applicable guidelines.Communicate clinical information and coordinate timelines with multiple internal departments.Provide clinical and FDA/ICH support for other areas within the companyPrepare clinical documents for ANDA/NDA submissionsParticipate in the development or implementation of clinical trial documents.Support regulatory department in response to FDA deficiency lettersMaintain current knowledge of relevant regulations, including proposed and final rules.Interface with departments within and outside including R&D, Regulatory Affairs, Pharmacovigilance, Marketing and Sales.Set up and maintenance of Sponsor Trial Master Files, following the internal procedure for filing of essential documents EXPERIENCE:B.Sc. in pharmacy or life science or higher degree and at least 5 years of clinical research experience.Good understanding of the drug development process, GMP/GLP/GCP & ICH/FDA regulations and guidelinesExperience in conducting studies for Regulatory AgenciesKnowledge of applicable regulations, ICH guidelines and GCP directives.Experience in biopharmaceutical aspect of drug product development.7+ years of experience in pharmaceutical industry with at least three years of extensive experience in biopharmaceutical aspect of drug product development.Ability to multi-task and manage several projects in parallel, paying attention to detail.Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashionGood project planning, negotiation and presentation skills.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.