Clinical Research Scientist_BioPharma
The businesses of Merck KGaA, Darmstadt, Germany · JP
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About the Role
The Clinical Research Scientist (CRS) partners with the Medical Lead to provide scientific, clinical, strategic, and operational input to an early or late-stage clinical development program. The CRS contributes to data interpretation, study designs, regulatory and study documents, and publication efforts, while also providing scientific input into pipeline programs. Medical Monitoring and Medical Data Review activities are conducted in close collaboration with the Medical Lead.
Responsibilities
- Manage assigned activities within clinical study independently and in support of the Medical Lead.
- Provide clinical/scientific input and gather necessary information from other areas to clinical development plans.
- Perform Medical Monitoring and Medical Data Review in close collaboration with the Medical Lead.
- Assist Contract Research Organizations and other vendors on medical monitoring activities, supporting project execution in partnership with Global Development Operations.
- Work on the design of clinical trial concepts, study protocols, assessment schedules, patient information material, and clinical study reports in support of the Medical Lead.
- Prepare relevant sections of the common technical document dossier while supporting clinical trial-related submission activities and marketing authorization submissions.
- Assist in the design and organization of content for relevant Advisory Board Meetings.
- Draft sections for clinical trial protocols, including most recent literature citations.
- Collaborate with Medical Communications to ensure all relevant documentation is updated with new medical information.
- Assume responsibility for the incorporation of additional information into the Investigator Brochure in coordination with various experts.
- Provide scientific, clinical, strategic, and operational input to clinical development programs.
- Contribute to data interpretation, study designs, regulatory and study documents, and publication efforts.
- Provide scientific input into pipeline programs.
- Conduct Medical Monitoring and Medical Data Review activities.
- Interact with multi-disciplinary, global and Japan teams ensuring scientific, clinical and other topics are appropriately considered.
- Escalate complex data findings to the Medical Lead.
- Manage assigned activities within clinical study independently.
- Gather necessary information from other areas to clinical development plans.
- Support operational excellence of project execution.
- Oversee Medical Data Reviewers with the support of the Medical Lead.
Requirements
- High analytical skills, strategic thinking, and a growth mindset.
- Ability to work on assigned tasks or projects with scientific rigor and utilizing up-to-date information technology.
- Expert knowledge of scientific principles and concepts.
- Knowledge of regulatory requirements, including ICH-GCP strongly preferred.
- Aptitude to interpret and integrate complex data, including clinical safety and efficacy data, pharmacokinetics, biomarker and next generation sequencing data.
- Good medical or clinical knowledge and experience in clinical development/operations.
- Capacity to monitor laboratory data and other clinical trial data.
- Capability to perform literature searches and utilize library services, digest information, and synthesize key take-away points.
- Good communication and presentation skills.
- Receives general instruction on routine work and more detailed instruction on new assignments.
- Educational and/or work experience in the respective therapeutic area is desirable.
- Proficient organizational and project management skills.
- Ability to work in a matrix environment of cultural diversity and in a global setting.
- Effectively drive projects even in uncertain and ambiguous situations.
- Minimum of 2 years of experience in product and clinical development.
- At least 3 years of experience in a comparable setting in the pharmaceutical industry or biopharma/healthcare setting, preferred.
Skills
- Scientific principles and concepts
- Regulatory requirements
- ICH-GCP
- Clinical safety data interpretation
- Efficacy data interpretation
- Pharmacokinetics interpretation
- Biomarker data interpretation
- Next generation sequencing data interpretation
- Medical knowledge
- Clinical development
- Clinical operations
- Laboratory data monitoring
- Clinical trial data monitoring
- Literature searches
- Library services utilization
- Information synthesis
- Communication skills
- Presentation skills
- Organizational skills
- Project management skills
- Matrix environment adaptability
- Global setting adaptability
- Driving projects in uncertainty
- Driving projects in ambiguity
Experience Level
- Minimum of 2 years in product and clinical development
- At least 3 years in a comparable setting in the pharmaceutical industry or biopharma/healthcare setting
Education Level
- Bachelor's Degree required
- Degree in life sciences preferred
- Advanced degree in life sciences (e.g., PharmD, PhD, MS, MPH) preferred