New PT Clinical Development Scientist Job in Lexington, MA!
Position Title: PT Clinical Development Scientist

Position Number: 340478

Location: Lexington, MA 02421

Position Type: Long Term Contract

Required Skill Set:

Clinical, Pharmaceutical, Scientist

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Clinical Development Scientist IV (PART TIME)

Start Date: ASAP
Duration: 05/21/2021

Location: Lexington, MA 02421

Part time hours: 20 hrs/week


Primary Role:
• Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of GCDL/GDTL
• Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
• Provides clinical scientist input into all regulatory questions, runs ad hoc searches
• Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
• Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,
• Support GDTL/GCDL to provide scientific leadership in execution of clinical trials
• Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
• Serve as a resource to address medical questions or clarify issues arising during conduct of the study
• Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
• Assist in the review, analysis and reporting of clinical trial data
• Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
• Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution (Director)
• This position may be combined with the GCDL position when the program is limited in its scope and complexity (Director)

Responsibilities:
100%:
• Collaborates with Global Development Team Lead, and Global Clinical Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent;
• Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
• Supports the GDTL or GCDL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
• Assist the GDTL/GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Supports the GDTL/GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.
• Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
• Participates in drug safety surveillance for Development projects.
• Act on behalf of GCDL/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc,

Education & Experience Requirements:
• Bachelor''s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
• Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
• Demonstrated ability to collaborate in a matrixed environment
• Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
• Experience in designing and conducting Phase II-III clinical trials; and/or
• Significant late-stage development research.

Other Job Requirements:
• Availability to travel approximately 25% of time.
• Availability to participate in early or late meetings/teleconferences.
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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About Rose
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