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Merck · 1 day ago

Clinical Director (Principal Scientist), Clinical Research - Lymphoma

USA - Massachusetts - Boston (MA Parcel B Laboratory)

Full-time

Hybrid

Lead/Staff, Director/Executive

$256K/yr - $403K/yr

4+ years exp

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The Clinical Director (Principal Scientist) will oversee clinical research activities for oncology medicines, managing the entire cycle of clinical development including study design, monitoring, and regulatory reporting.

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 of clinical development strategies for investigational or marketed Oncology drugs

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 Oncology 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; and

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

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 Senior/Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's 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

Facilitate 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 DevelopmentOncologyClinical ResearchClinical Trial DesignsDrug DevelopmentHematologic MalignanciesScientific ResearchClinical Trials MonitoringClinical JudgmentResearch MethodologiesAcademic PresentationsClinical InvestigationsClinical Trial PlanningClinical TrialsClinical Trial SupportEthical StandardsMedical OncologyLymphomaHematologyCross-Functional Teamwork