Clinical Scientist or Senior Clinical Scientist - Merz North America, Inc

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 including development of clinical outcome assessment (COA) tools, 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.

Essential Duties and Responsibilities

• Accountable for contributing scientific expertise to the trial design phase of clinical projects under development: 
  • Provide scientific and strategic input across various stages of clinical development to achieve market approval for new products and/or novel indications:
    
    • Duties performed as a member of a cross-functional team of internal and external experts and in support of the medical director
    • Projects are focused on devices, drugs, biologics, and/or other products for human use
    • 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)
• Accountable for authorship of various clinical documents, including clinical study outlines, clinical investigation plans and amendments, clinical investigation reports and investigators brochures, if applicable:
  
  • 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
• Accountable Accountable for contributing scientific expertise to the trial set-up and execution phases of clinical projects, including results interpretation and reporting:
  
  • Support, as a member of a cross-functional team, the preparation of additional trial related documents (e.g., Informed Consent Form, Case Report Form, site-training materials) and other operational aspects of assigned studies
  • Support and provide scientific input for activities related to data collection, cleaning, validation, and analysis, spanning from development / user-acceptance testing (UAT) of CRFs to review of data tables and listings
  • Perform and/or support ongoing review of in-progress trial data and provide guidance for site-related questions
  • Work with assigned biostatistician to anticipate necessary analyses and data tables to best present resultant data
  • Evaluate and interpret trial data and results (tables, figures and listings) and align with key messaging with support from the project team
  • Prepare/review data or other information for internal and/or external investigators (e.g., topline result presentations)
• Accountable for contributing scientific expertise to study teams to develop clinical outcome assessment (COA) tools:
  • 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
• Accountable for contributing scientific expertise to regulatory activities: 
  • Provide scientific expertise for regulatory submission documents (e.g., meeting packages, investigational device exemption (IDE) investigational new drug (IND) applications, and sections of marketing applications (PMA/NDA/MAA/CTD) or other submissions depending on host country)
  • Support in-person, virtual, and written interactions with and submissions to regulatory bodies
• Accountable for contributing scientific expertise to product maintenance activities: 
  • 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
• Accountable for contributing scientific expertise to the presentation and publication of clinical trials results:
  • 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&D, Medical Affairs, and Commercial colleagues
  • Demonstrate knowledge of Good Publication Practices and editorial policies and apply expertise to publishing projects
• Accountable for providing oversight of external medical writing vendors:
  • Effectively manager assigned writing projects, including projects outsourced to vendors
  • Oversee and review work of external writers to ensure Merz SOPs are followed, correct templates are used, and quality is maintained
• Accountable for supporting organizational development, compliance, and training:
  • Participate in the development, improvement, and optimization of internal processes (e.g., workshops, taskforces, SOPs, work instructions, etc.), working toward efficiency and consistency
• Additional accountabilities:
  • Establish general proficiency of applicable therapeutic area, gathering relevant product knowledge for application in assigned projects
  • Contribute scientific expertise in support of business-development activities, including assisting in the identification and assessment of new opportunities
  • Contribute scientific expertise in support of due diligence / in-licensing of products, including consultation with external experts
  • Provide scientific input for aesthetic scale development and validation activities

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Clinical Scientist at least 3 years of clinical (development) research experience, including design and conduct of clinical trials, in the pharmaceutical and/or medical device, health science, or biotech industry or equivalent combination of education, training, and experience
  • Senior Clinical Scientist at least 5 years of clinical (development) research experience, including design and conduct of clinical trials, in the pharmaceutical and/or medical device, health science, or biotech industry or equivalent combination of education, training, and experience
  • Demonstrated competency in methodological development and review of clinical, regulatory, and scientific documents
  • Demonstration of strong medical-writing skills (e.g., peer-reviewed publications; scientific presentations; IDEs/PMAs, IND/NDA modules, investigator brochures, study protocols, CSRs)
• Preferred:
  • Experienced in the development and use of clinical outcome assessment (COA) tools including patient reported outcome tools, clinician reported outcome tools and/or photo scales

Knowledge, Skills and Abilities

• Required:
  • Demonstration of excellent verbal and written English, including understanding of English language usage in clinical/technical environments and standardized-writing styles
  • Demonstrated ability to develop and lead effective project teams, capitalizing on individual and team strengths, to achieve objectives
  • Demonstrated ability to foster constructive interactions, including conflict resolution, with various stakeholders
  • Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155
  • Understanding of clinical product development, clinical trials, and global regulatory submissions
  • Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables
  • Readily adaptable to changes in priorities
  • Able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Able to engage in an open, constructive, and continuous dialogue
  • Able to develop solutions to complex problems that are consistent with company objectives
  • Experienced user of Microsoft applications (e.g., Word, PowerPoint, Excel, SharePoint)
• Preferred:
  • Experience in working with templates, style guides, medical-database searches (e.g., Medline, PubMed) and reference manager software (e.g., EndNote)

Education

• Required: 
  • Master's Degree in Life Sciences
  • PhD, DrPH, PharmD, etc (Senior Clinical Scientist)
• Preferred:
  • PhD, DrPH, PharmD, etc (Clinical Scientist)

Personal Skills

• Required:
  • Highly motivated, self-driven and dependable
  • Strong ability to work collaboratively and to respect others working cultures
  • Able to work independently and proactively
  • Possess a sense of urgency, accuracy and attention to detail

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development