Clinical Research Scientist

Job description

Specific Job Description Key Accountabilities As a subject matter expert, 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 as well as providing scientific input into pipeline programs. Medical Monitoring and Medical Data Review activities are conducted in close collaboration with the Medical Lead, including oversight of any Medical Monitoring activities performed by contracted vendors. The CRS interacts with multi-disciplinary, globa l and Japan team s ensuring that scientific, clinical and other topics are appropriately considered with respect to highly complex data findings and escalated to Medical Lead. FINANCIAL DIMENSION Responsible for a cost-effective approach to development plan activities. Strategic Impact Within the frame of the clinical development of new medicines, the CRS is responsible for Managing assigned activities within clinical study independently and in support of the Medical Lead Providing clinical/scientific input and gathering necessary information from other areas to clinical development plans Involved in Medical Monitoring and Medical Data Review in close collaboration with the Medical Lead Assisting closely with Contract Research Organizations and other vendors on medical monitoring activities, supporting to the operational excellence of project execution in partnership with Global Development Operations Working on the design of clinical trial concepts, study protocols, assessment schedules, patient information material as well as clinical study reports in support of the Medical Lead Preparing the relevant sections of the common technical document dossier while supporting clinical trial-related submission activities and marketing authorization submissions Assisting in the design and organization of the content for relevant Advisory Board Meetings Drafting sections for clinical trial protocols, including most recent literature citations Collaborating closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of additional information into the Investigator Brochure in coordination with various experts Cooperation Internally Externally All functions in R&D in particular Global Development Operations, Clinical Measurement Science, Global Regulatory Affairs, Medical Unit, Research Unit and Global Patient Safety, CMC Development, Global Project Management, and R&D Quality functions Commercial functions Legal, Patent, Communication functions Business Development/External Innovation and Alliance Management functions Medical experts and key opinion leaders Study-related committees External consultants for the respective projects Contract Research Organizations Site(s)/Monitor(s) Candidate’s Profile The CRS is an individual contributor with high analytical skills, strategic thinking, and a growth mindset. With direct oversight and guidance, able 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 to 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 with the capacity to monitor laboratory data and other clinical trial data Capability to perform literature searches and to utilize library services, digest the information, and synthesize the key take-away points Good communication and presentation skills Normally 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 level of organizational and project management skills Able to oversee Medical Data Reviewers with the support of Medical Lead. Adeptness to work in a matrix environment of cultural diversity and in a global setting Effectively drive projects even in uncertain and ambiguous situations Bachelor's Degree required, degree in life sciences preferred. Experience in product and clinical development (minimum of 2 year, with at least 3 years in a comparable setting in the pharmaceutical industry or biopharma/healthcare setting , preferred) . Advanced degree in life sciences (e.g., PharmD, PhD, MS, MPH) preferred.