Ribosome Research Centre Private Limited is a leading, Gujarat-based Contract Research Organization providing a wide range of non clinical research services aimed to deliver to a spectrum of industries like Pharmaceuticals, Herbals, Bulk drugs, Chemicals, Agro-chemicals, Medical devices, Food and cosmetics manufacturers. The research facility has employed state-of-the-art facility across its landscape spread over 100,000 sq ft in an 8 acre campus.
Post : Scientist-Preclinical Research
Job Description
Reporting to the Chief Scientific Officer, the Scientist, Preclinical Research, is responsible for oversight of day-to-day non-clinical research activities across multiple biotherapeutic programs in immune oncology and orphan diseases. In addition, the Scientist, Preclinical Research, will contribute to the overall research plan for programs within the corporate portfolio.
The Scientist, Preclinical Research, will interface with functional groups across the organization to coordinate research activities, as well as manage external CRO and research collaboration partners. This position provides an opportunity to contribute to the building of a pipeline of promising biotherapeutics for treatment of life-threatening diseases though to launch of first-in-human trials.
- Coordinate regulatory preclinical development studies
- Defining strategies, together with the project team, for the early development of NCE's
- Manage the transition from drug discovery to preclinical development, and preclinical development to Phase I/Proof of Concept (POC) clinical trials
- Ensuring the effective selection of preclinical development compounds and defines backup strategies Together with the Drug Discovery Team
- Managing internal pre clinical trials
- Managing the selection and outsourcing of Preclinical studies to Contract Research Organizations (CROs)
- Managing development issues through close interaction with research and development groups (e.g.Technical Operations, Clinical Development, QA and Regulatory, etc)
- Review and validation of the studies documentation, analysis and discussion about the results, with Genfit’s Staffs or with the CROs and the experts
- Writing / updating of the preclinical part of the regulatory documents (IMPD, IND, IB)
- Writing of the SOPs
Responsibilities
• Contribute to protein engineering and design of novel biotherapeutics (antibodies, Fc- Fused traps).
• Contribute execution and interpretation of pharmacology studies, with particular emphasis on in-vivo studies, for the evaluation and characterization of new biotherapeutics.
• Write study protocols, craft and review final reports for internal and external use; organize data presentations and report as needed to CSO
• Identify and vet CROs, and in conjunction with the CSO, academic groups, or organizations to conduct preclinical and bioassay studies related to mechanism of action, preclinical compound testing and lead candidate selection and development.
• Coordinate day-to-day execution/oversight of internal/external Research studies for multiple programs, ensuring performance, timeliness and integrity of data.
• Manage and work closely with the scientific staff to ensure alignment with corporate/partnering and IP needs.
• Contribute to the development of research programs based on an understanding of the pathophysiology of disease and mechanism of action of biotherapeutics.
• Independently review and apply scientific literature, his/her own scientific knowledge, and the appropriate regulatory requirements to Research efforts.
• Identify risks, develop risk mitigation plans, and escalate risk mitigation strategies to the SVP Research as appropriate.
• Contribute to in-licensing program due diligence and regulatory submissions.
• Contribute to the generation of company public disclosures including scientific posters and publications, patent applications and IR documents.
• Other related duties as assigned.
Candidate Profile
- PhD or Master in pharmacology & Toxicology Or Life science.
- Minimum of 5 years’ experience in the pharmaceutical industry within Pre-Clinical sector.
Experience in regulatory preclinical development studies, including studies management in the fields of Toxicology or ADME.
- Good knowledge of the GLP
- Experience selecting and managing CRO relationships
- Project management experience
- Good team skills and ability to work in an interdisciplinary and international environment
- Excellent oral and written communication skills (English & French)
- Autonomous and rigorous.
Additional Information
Experience : Ph.D, or M.Pharm, M.Sc
Qualification : 5 years
Location : Kim,Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharma/Biotech/CRO
End Date : 15th June, 2021
Submit your CV and cover letter in PDF format. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.
E-Mail : hrd@sdparc.com
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