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location: Lexington, Massachusetts
job type: Contract
salary: $65.78 - 77.39 per hour
work hours: 9 to 5
- Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GCDL
- 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 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.
- Collaborates with Global Development Clinical Lead, and Global Product 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 GCDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.
- Assist the 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 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 leading the interpretation of trial data and development and review of clinical study documents, reports etc,
- 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.
- Availability to travel approximately 25% of time.
- Availability to participate in early or late meetings/teleconferences.
skills: IND, NDA, Clinical research, Maa, Clinical Study Design, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.