Clinical Scientist – Clinical Development (M/F/D) (Us)

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:

The Clinical Scientist will support the clinical development 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.

Main Responsibilities:

• Writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other document.
• Monitor clinical data for specific trends. Analyze, interpret and author reports of scientific data from clinical studies.
• 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).
• Develop site and CRA training materials of the protocol and present these at SIVs and Investigator meetings
• 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.)
• 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).
• Responsible developing a basket and/or umbrella clinical study design.

Qualifications & Skills:

• Proficient with Microsoft Word/Excel/PowerPoint and GraphPad Prism (preferred)
• Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
• 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.
• PhD, MD, PharmD, or MS in life sciences with some previous experience in clinical research or clinical development experience.
• Experience in working in an umbrella and/or basket clinical study design.
• Proficient experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative.
• Must have project management skills (develop short range plans that are realistic and effective)
• Scientific expertise or ability to learn in the domain of assigned study/project. Basic knowledge of disease area, compound, current clinical landscape is required.
• 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.

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).
• Excellent communication skills, oral and written, are required.
• Capability to challenge decision and status quo.
• The ability to work cross-functionally is essential.
• Ability to synthesize the information, good presentation skills.
• Quality focused and well organized.
• Excellent decision-making and problem-solving capabilities.
• Strong knowledge of clinical research and the drug development process required.
• Ability to anticipate and timely escalate issues and to define appropriate action plans.
• Proven ability to work independently and in a team setting is essential.
• High level of autonomy and motivation.
• Ability to handle multiple tasks and to prioritize.

What we offer:

• An excellent working atmosphere
• Strong team with dedicated and passionate employees
• Opportunities for personal development
• Working in a multinational and multicultural environment
• State of the art infrastructure
• Employee benefits

We offer a comprehensive package with a competitive annual salary in the range of 100k – 160k (depending on experience and qualification the salary can be negotiated), 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

Contact:

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 protected]

For more information on HOOKIPA please visit www.hookipapharma.com