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Merck · 4 months ago

Senior Principal Scientist, Clinical Research, Neuroscience

USA - Pennsylvania - North Wales (Upper Gwynedd)

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$277K/yr - $435K/yr

3+ years exp

Merck is a leading global healthcare company, and they are seeking a Senior Principal Scientist in Clinical Research focused on Neuroscience. The role involves planning and directing clinical research activities, managing clinical trials, and providing scientific leadership across various projects.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

Responsibilities

Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications

Developing clinical development strategies for investigational or marketed Neuroscience drugs that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations

Planning clinical trials (design, operational plans, settings) based on these clinical development strategies

Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Neuroscience drugs

Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication

Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds; and

Support of business development assessments of external opportunities

Provide support for other therapeutic areas regarding clinical issues related to Neuroscience

Supervise the activities of Clinical Scientists in the execution of clinical studies

Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility

Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies

Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs

Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs

Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility

Author detailed development documents, presentations, budgets, and position papers for internal and external audiences

Facilitating collaborations with external researchers around the world

Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects

Qualification

Clinical ResearchClinical DevelopmentDrug DevelopmentNeuroscienceRegulatory Affairs ComplianceScientific LeadershipInterdisciplinary Problem SolvingEthical StandardsData AnalysisInterpersonal Skills