The primary role of the Clinical Scientist, Infectious Disease, is to provide scientific expertise to clinical development programs including strategic input and development support for clinical plans and individual study protocols, with an initial focus on SARS-CoV-2 (coronavirus). This role will work on cross-functional study teams for the design and execution of global clinical studies, as well as analysis, interpretation, and communication of clinical study data. Essential duties and responsibilities include but are not limited to the following:
- Provide clinical research input for SARS-CoV-2 vaccine candidates and support Target Product Profile development
- Contribute to the clinical development strategy, clinical development plans, and prepare clinical protocols for trials of SARS-CoV-2 vaccines
- Prepare clinical development plans and protocols and the conduct of clinical research in accordance with Good Clinical Practices (GCP) and the standards of the International Conference on Harmonization (ICH)
- Close and productive communication with clinical sites to ensure patient eligibility, treatment, and appropriate reporting of clinical data
- Assist in the composition and review of clinical study reports, Investigational Drug Brochures, manuscripts, abstracts, General Investigational Plans, and other relevant documents
- Identify risks and recommend potential mitigation strategies that can impact the successful execution of a clinical study
- Analytical support of clinical trial data (safety and, efficacy, and biomarkers), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
- Composing internal and external presentations for scientific meetings (eg, investigator meetings, advisory boards, data presentations)
- Support and mentor Clinical Science/Medical staff on all projects assigned to company
- Provide review of clinical development plans and strategic initiative (e.g. task forces, protocol review committees)
- These efforts will facilitate the efficient development and execution of clinical studies to support the development of groundbreaking, innovative vaccines against SARS-CoV-2. Additional programs against other viruses may be launched in the future.
- Advanced degree in a scientific discipline; PhD, PharmD, MD, or equivalent degree preferred. Master’s degree may be considered if candidate has substantial industry experience.
- 5+ years of relevant experience in biotechnology/pharmaceutical industry
- 5+ years experience in clinical development or clinical research with practical knowledge of the drug development process; including conducting Phase 1 to 3 clinical studies and submission of Investigational New Drug Applications.
- Ability to work effectively in a fluid, fast-paced, team-based environment
- Self-motivated, self-disciplined and able to function independently as well as part of a team
- Contribute to the development and use of novel strategies to improve the efficiency of clinical studies
- Highly organized with attention to detail, clarity, accuracy, and conciseness
- Strategic agility, strong critical and logical thinking with ability to analyze problems
- Strong presentation and written/verbal communication skills
- Excellent computer proficiency (MS Word, Excel, PowerPoint)