- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Main Duties and Responsibilities
- The Medical Scientist will be a renowned expert in own field and may specialize in more than one area. This individual will work independently with guidance in only the most complex situations and serve as a close partner to the physician on the team. S/he may coordinate the activity of a research team and will hold full accountability for projects, often with Global impact.
- This position will have key relationships internally with clinical project teams, marketing and business development, and brand or therapy area team leaders, and externally with regulatory bodies and external service providers.
- Integrate the research and commercial aspects of drug development to ensure successful, value creating product development, either by overseeing a team of clinical research professionals, or by supporting such a team as an expert in one or more areas of clinical research.
- Ensure there is adequate input into the drug development process from experts in each of the various areas of drug development, or provide input into one or more of these areas as a technical expert.
- Develop and design studies to determine the scientific or commercial viability of a particular drug or portfolio of drugs and interpret the results of these studies, either as the head of a team, or by providing expert input.
- Participate in protocol writing and strategy. Ensure that all aspects of work being carried out by self or team is done with a focus on the commercial viability of the drug under development.
- Coordinate actions between research and development, manufacturing and marketing teams to ensure the success of product development at each stage of the product life cycle. Communicate information to multiple teams in various areas of the drug development process, ensuring all involved parties are aware of important developments in other areas of the product life cycle.
- Manage cross functional projects to ensure the successful passage of drugs through all phases of the drug development process, or contribute to one or more elements of such a project as a technical expert.
- May performance manage a team of clinical research professionals, setting goals and objectives and overseeing their professional development. Ensure own work, and work of team, is compliant with Safety, Health and Environment standards and all other relevant internal and external regulations.
- Review and interpret medical data and clinical trial data and come up with conclusions. Review patient consent forms and provide opinion on whether or not matches the data. Engage in literature search and author background section of the disease from the literature search.
- Provide initial screening for study proposals to ensure information’s accurate; provide first review of the ISS proposals. Have responsibility for delivery of pieces of the trials. May lead submissions from a process standpoint.
Qualifications
- PhD in a scientific field is required; considerable relevant experience in the pharmaceutical industry is preferred, however academic experience will be considered provided the candidate has current immune-therapy / oncology clinical trials experience.
- Good transferable project experience across phases I - III drug development.
- Experience managing and interpreting the results of clinical trials as well as exposure to writing protocols to some degree.
- Strong analytical skills.
- Experience of authoring scientific documents.
- Experience leading and managing a team and project management experience is desirable (evidence of leading cross functional teams focussing on good communication, passion for customers and working collaboratively).
- Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partners.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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