Clinical Scientist

vor 7 Monaten

Wien, Österreich Hookipa Pharma Vollzeit

**About HOOKIPA**:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.

**Position Summary**:
**Main Responsibilities**:

- 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.)

**Qualifications & Skills**:

- 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 an 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.
- 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
- Working in a multinational and multicultural environment

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 4.112, - based on fulltime (14 monthly salaries per annum/ 40 hours per week); depending on experience and qualification the salary can be negotiated. In addition, we offer a p

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