Senior Principal Scientist, Clinical Research, Lymphoma

Merck • North Wales, PA

2d • Hybrid

About The Position

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company, one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Senior Director (Senior Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.
Specifically, the Senior Director may be responsible for:
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.
In executing these duties, the Senior Director may:
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 competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within their 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 companies investigational and marketed drugs;
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our drugs; and
Attend appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.

Requirements

• M.D or M.D./Ph.D
• Must have experience in industry or academia
• Demonstrated record of scientific scholarship and achievement
• A proven track record in clinical medicine and background in biomedical research is essential
• Strong interpersonal skills, as well as the ability to function in a team environment are essential
• Clinical Development
• Clinical Judgment
• Clinical Medicine
• Clinical Research
• Clinical Trial Designs
• Clinical Trial Development
• Clinical Trials
• Clinical Trials Monitoring
• Data Analysis
• Hematologic Malignancies
• Intellectual Curiosity
• Oncology
• Regulatory Compliance
• Research Methodologies
• Safety Management
• Strategic Planning

Nice To Haves

• Board Certified or Eligible in Oncology (and/or Hematology)
• Prior specific experience in clinical research and prior publication is desirable but not necessary

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
• 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
• Assist the Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of our competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
• Maintaining awareness of scientific developments within their 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 companies investigational and marketed drugs
• Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our drugs
• Attend appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree