Clinical Scientist – Clinical Trial Management
|Date posted:||03. June 2022|
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 / amendments in collaboration with cross-functional facilitation. Clinical Scientist will serve as the project manager of developing the protocol and collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs).
- Responsible developing a basket and/or umbrella clinical study design.
- Monitor clinical data for specific trends. Analyze, interpret and author reports of scientific data from clinical studies.
- Writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, 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 (eg., protocols, eCRFs, ICFs, CSRs).
- 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 (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- PhD, MD, PharmD, or MS in life sciences with some previous experience in clinical research or clinical development experience.
- Must have 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.
- Experience in working in a umbrella and/or basket clinical study design.
- 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.
- Must have project management skills (develop short range plans that are realistic and effective)
- Proficient with Microsoft Word/Excel/PowerPoint and GraphPad Prism (preferred)
Key Personal Attributes:
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
- The ability to work cross-functionally is essential.
- Excellent communication skills, oral and written, are required.
- Strong knowledge of clinical research and the drug development process required.
- Proven ability to work independently and in a team setting is essential.
- High level of autonomy and motivation.
- Quality focused and well organized.
- Ability to handle multiple tasks and to prioritize.
- Ability to synthesize the information, good presentation skills.
- Excellent decision-making and problem-solving capabilities.
- Capability to challenge decision and status quo.
- Ability to anticipate and timely escalate issues and to define appropriate action plans.
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Employee benefits such as health screening, public transportation card, Sodexo pass
- 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
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: email@example.com
For more information on HOOKIPA please visit www.hookipapharma.com