Sr. Clinical Scientist Raleigh, NC - hybrid, Tues.-Thurs. 6 mo. contract, possible permanent hire Must-Haves: Masters Degree in Life Sciences Understanding of clinical product development, clinical trials, and global regulatory submissions Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155 Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables Readily adaptable to changes in priorities Demonstration of excellent verbal and written English, including understanding of English language usage in clinical/technical environments and standardized-writing styles. Plusses: PhD, Dr. PH, or MD Job Description: Serves as a key role within the Merz Aesthetics Research and Development team, the (Senior ) Clinical Scientist is responsible for contributing scientific and strategic expertise to our global clinical programs. Liaising with cross-functional study teams, this position requires a highly motivated, scientifically driven leader to contribute to the development of clinical strategy study design and execution, and data analysis and interpretation, delivering clear, consistent, and comprehensive results toward the registration of new aesthetic products and/or novel aesthetic indications. This position is initially offered as a six month fixed term contract with the potential to be considered for permanent employment thereafter, subject to business needs and individual performance. Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications. a. Duties performed as a member of a cross-functional team of internal and external experts and in support of the clinical director. b. Projects are focused on medical devices, drugs, biologics, and/or other products for human use. c. Projects may span from in-development to post-marketing studies and products. Coordinate and integrate data and information from a variety of sources (e.g., internal and external studies, research documentation, and published literature) to support various clinical development initiatives. Consolidate input from internal and external contributors to develop appropriate key messaging. Support early-phase development activities, including curation, review, and interpretation of preclinical, exploratory data. Provide scientific guidance and technical expertise within teams, across departments, and across functions by providing strategic, actionable direction, creating a strong sense of team unity and identity, and providing positive, constructive feedback. Identify and troubleshoot study-specific issues, competing priorities, and clinical or scientific challenges. Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management. Support planning and preparation for internal and external stakeholder meetings (e.g., workshops/summits, investigator meetings, scientific advisory boards, and regulatory meetings) Write, review, edit, and approve high-quality and timely clinical documents, contributing scientific/technical expertise related to clinical development and document preparation. Demonstrate understanding and interpretation of data generated from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature and provide meaningful scientific interpretation and feedback to team members and other stakeholders. Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plans. Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures. Proactively identify risks and escalate current/active/future issues; propose and enact solutions, developing contingency plans as needed. Ensure the successful execution and presentation of critical documents to leadership. Support, as a member of a cross-functional team the selection of relevant COAs Support and provide scientific input for activities related to the development/validation of project specific COAs Provide scientific input for clinical parts of key regulatory and project documents (e.g., Clinical Evaluation Plan (CEP) and Report (CER), Instructions for Use, and Post-Market Clinical Follow-up Plan (PMCFP) and Report (PMCFR). Provide scientific input for appropriate disclosure of clinical trial data in public registries. Prepare and present trial data, to internal and external stakeholders, using clear, concise, and consistent result summaries. Provide scientific and written expertise for manuscripts, abstracts, and poster submissions in collaboration with R
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