Location: Malvern, PA
Reports to: Head of Clinical Development, Infectious Disease & Immunology
The Clinical Scientist, Infectious Diseases & Immunology is responsible for the design and implementation of clinical projects for the infectious diseases & immunology-based business unit of the Company. This individual will develop statistical plans and perform preliminary and exploratory data analysis of completed clinical trials.
Duties and Responsibilities
- Contribute to the development of multiple Phase I-IV clinical research trials specific to the drug development process for Ocugen’ s infectious diseases and immunology pipeline.
- Provide scientific input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
- Engage and influence a diverse scientific community of internal and external experts, including collaborations.
- Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study.
- Lead and contribute to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions.
- Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.
- Integrate data from internal, and external academic, conference and competitor sources.
- Interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.
- Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP).
- Ensure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
- Accountable, in collaboration with Medical Director, for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP.
- Author the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings.
- Provide input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM).
- Contribute to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.) and ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.
- Contribute for ensuring the Go/No-Go criteria have been set for the study.
- Presents, when warranted, the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conduct.
- Additional tasks and projects as requested.
- Current or prior license to practice in Medicine and/or Ph.D. in infectious diseases or immunology.
- 3+ years of relevant industry experience in drug development and clinical research.
- 3+ years’ experience within CRO or pharma/biotech industry; experience with clinical trials pertaining to vaccines preferred.
- Comprehensive understanding of applicable clinical research regulations.
- Demonstrated cross-functional collaboration skills with proven experience to drive productivity, efficiency, and quality.
- Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment.
- Understand and experience in data management, statistics, and project management necessary for successful study execution.
- Excellent scientific writing and oral communication skills.
- Ability to set priorities, direct multiple projects, and implement complex strategies.
- Excellent analytical and problem-solving skills.
- Proven negotiating experience with internal and external stakeholders.
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of normal hours to handle priority business needs.
This is a largely sedentary role.
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