Sr./Director, Clinical Scientist

Highly Competitive Salary
  1. Permanent
  2. Clinical Scientist
  3. United States
New York, USA
Posting date: 05 Sep 2019
CR.KD.25223_1567708655

Proclinical is currently recruiting for a Senior Clinical Scientist for a pharmaceutical company located in New York, NY. Successful candidate will support project team with design and implementation of clinical studies with emphasis on the protocol/therapeutic area specific activities (e.g., data management deliverables, protocol level plans, operational feasibility, database updates, preparation of meeting materials, preparation of regulatory agency documents, clinical supplies planning, communication plans, safety and medical monitoring, preparation of status update reports, study close-out activities).

Job Responsibilities:

  • Support scientific aspects of clinical trials and program level activities as assigned.
  • Contribute to authoring of clinical sections of protocols, clinical study reports, regulatory agency update reports, and other clinical and regulatory documents with focus on more routine/standard document elements. Interacts with internal and external stakeholders support of clinical trial objectives.
  • Support the Project Leader to interface with project team members including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Prepare or assist with preparation of key documents.
  • Actively monitors study execution to ensure highest level of scientific activities.
  • Protocol and Clinical study report preparation.
  • Participate in Development Planning for assigned compounds.
  • Participate and present at investigator meetings.

Skills and Requirements:

  • Doctorate degree in the life sciences or related field; for exceptional candidates, Masters-level degrees will be considered.
  • 5+ years in clinical drug development or in the Pharmaceutical/Biotech industry
  • CNS experience required. Gene therapy a real plus.
  • Understanding scientific process, as well as medical and statistical concepts.
  • Understanding of clinical research process from program planning to regulatory submission.
  • Ability to contribute and collaborate with a team including issue identification and resolution.
  • Interest in assessing business processes and developing improvements.
  • Must be able to make independent, timely and appropriate decisions.
  • Must have good communication and solid computer/analytical skills.
  • Excellent written and verbal communication skills and interpersonal skills. Must be able to interact effectively to people at all levels of the organization.
  • Knowledge of GCP and ICH Guidelines.
  • Detail-oriented, well-organized.
  • Ability to assimilate technical and scientific information quickly.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Demonstrated ability to work as part of a team.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#ClinicalDevelopement

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