Clinical Scientist - Clinical Trial Management
|Main focus:||Clinical Operation|
The Clinical Scientist will support the clinical operations team with all aspects of the translation of preclinical research into protocol development. The incumbent will serve as the project manager of developing the protocols and collaborate with internal stakeholders (e.g clinical operations, data management, statistics, safety, commercial, and regulatory affairs). Basic knowledge of disease areas, compound and current clinical landscape is required. The Clinical Scientist has to be willing and able to adjust to multiple demands and shifting priorities. The chosen candidate has to have ability to meet day-to-day challenges with confidence and professionalism.
- Lead the translation of preclinical research into protocol development, including starting dose and dose escalation, and generally provide justification of clinical plans through preclinical data
- Develop Protocol and Informed Consent Form documents in collaboration with cross-functional facilitation
- Monitor clinical data for specific trends as well as analyze, interpret and author reports of scientific data from clinical studies.
- Writing or reviewing results in study reports, regulatory submissions, abstracts, presentations, peer reviewed manuscripts, and other document.
- Develop site and CRA training materials of the protocol and present these at SIVs and Investigator meetings
- Contribute to the scientific development of individual clinical studies in alignment with the approved clinical development plan, including authoring and reviewing clinical documents
- Review clinical narratives (e.g., SAE reports, SUSAR reports)
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Provide clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory documents
- PhD, MD, PharmD, or MS in life sciences with some previous experience in clinical research or clinical development experience.
- At least 2-years of direct experience in Immuno-oncology and solid tumor oncology. Experience with virology and/or cell & gene therapy experience is strongly preferred.
- Scientific expertise or ability to learn in the domain of assigned study/project. Basic knowledge of disease area, compound, current clinical landscape is required.
- Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work.
- Proficient experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative.
- Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
- Project management skills
- Proficient with Microsoft Word/Excel/PowerPoint and GraphPad Prism (preferred)
- Ability to work cross-functionally is essential.
- Excellent communication skills, oral and written
- Ability to anticipate and timely escalate issues and to define appropriate action plans.
- Excellent decision-making and problem-solving capabilities
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible