Provide scientific oversight to clinical trials including protocol development, scientific support during study conduct and interpretation of results in addition to providing broad scientific input to strategic activities across the Company’s including: non-clinical development, clinical development, regulatory and business development. Represent non-clinical and clinical research at internal and external forums; key point of contact for scientifically-based initiatives. This role will work on cross-functional study teams for the design, execution, and monitoring of pre-clinical and clinical trials, as well as assist with data interpretation and communication. This role will also serve as a point of contact for CROs, central laboratories and investigators.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Provide scientific input to clinical research activities, including protocol development, study implementation, analysis and reporting of results.
- Responsible for developing the “mechanism of action story” for all BioLineRx molecules.
- Define and implement early clinical biomarker strategies.
- Direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
- Design, implement and oversee biomarker and diagnostic testing and data analysis.
- Contribute to the strategic planning, authoring, and review of regulatory submissions and scientific data disclosures.
- Provide scientific expertise and support to development team, regulatory affairs and business development BD.
- Present scientific information internally and externally.
- Support all scientific aspects of clinical trial(s) and program level activities as assigned, providing scientific expertise to study protocols, case report forms, laboratory selection, validation methodologies, biomarker assessments, statistical analysis plans, interpretation of results, clinical study reports, graphical displays.
- Scientific oversight and cleaning of key data for ongoing clinical trials throughout conduct.
- Scientific support of regulatory documents including annual reports, investigators’ brochures, briefing books, safety updates, IND/NDA submission documents, and responses to regulatory authority questions.
- Generate scientific slide decks based on pre-clinical and clinical trials; Generate data presentations for clinical study reports and regulatory submissions.
- Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
- General data compilation, interpretation, and communication; conduct literature searches in support of scientific topics.
- Provide quality control support as needed including clinical and regulatory documents, and slide decks.
- Support development of specific scientific topics of interest such as those for discussion at advisory boards (generate slide decks, conduct ad hoc data analyses, perform literature reviews).
- Scientific support of scientific data disclosures (manuscripts, abstracts, conference posters).
- Preparation and writing of scientific material for conference presentations or publications.
REQUIRED KNOWLEDGE AND ABILITIES:
- PhD in Immunology with at least 5 years of clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
- Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Excellent oral and written communication skills and solid computer/analytical skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously.
- General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Highly proficient in standard computer software (Word, Excel and Power Point).
- Ability to travel – in some cases, internationally (average travel expectation: <20%/year.)
- Hebrew and English at mother-tongue level
Please email CV to hr@BioLineRx.com