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DATE ADDED: Tue 05/11/2019

AD/Sr. Manager - Clinical Scientist

Watertown, MA, US
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COMPANY: APEX SYSTEMS, INC

JOB TYPE: Permanent, FullTime

Job Description
Job #: 1014524
Associate Director/Senior Manager, Clinical Scientist, 1014524
Job Scope & Purpose:
Our client is seeking an experienced, motivated AD/Sr. Manager of Clinical Research Scientist to join a growing team! The research and development activities use a robust, chemistry-driven approach in the development of small molecule drugs for the treatment of viral infections and liver diseases. This experienced Clinical Research Scientist will lead and support the conduct of the company's clinical trials.
Primary Job Responsibilities:
  • Design innovative and feasible clinical trials in collaboration with clinical development team members.
  • Regularly monitor, clean, analyze and review safety and efficacy data to identify and summarize findings and, as appropriate, may drive follow-up activities.
  • (Co-)Author clinical study-related documents including, but not limited to, protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
  • Interface with discovery, safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, and other members of the extended project teams
  • Interact frequently with investigators, site staff, CROs, and site monitors to optimize study engagement, maintain enthusiasm, and support further enrollment for ongoing clinical studies.
  • Maintain and analyze literature and competitive information for trial designs and results for the assigned therapeutic area.
  • Review and provide input on the statistical analysis plan.
  • Under medical supervision participate in tracking/analysis of any potential safety events within an individual clinical trial and across trials for assigned programs.
  • Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan.
  • Maintain current knowledge of the environment to ensure awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan by attending major scientific conferences, participating in competitive intelligence activities, and engaging in

Primary Job Requirements:
  • RN, MS, Ph.D. or PharmD, or equivalent. Advanced degree candidates preferred.
  • 3+ years of industry clinical development experience, with experience in clinical trials is required.
  • Extensive knowledge of clinical research, and experience across Phase I-III drug development projects.
  • Familiarity with clinical trial design and experience authoring clinical trial protocols (Phase I or II) is required.
  • Experience in analysis, interpretation, and presentation of clinical data to inform decision making and clinical strategy are required.
  • Must be well-versed in medical aspects of GCP, ICH, FDA, EMEA, and other relevant guidelines.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
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Code:ClinOps

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178. - provided by Dice
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