Senior Director Clinical Research, Infectious Disease (Can be Remote)
Location: Rahway, New Jersey
Type: Full Time
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.
Anti-infective drug development has been our core mission for over 80 years. Our Clinical Research group is at the forefront of global healthcare through research and innovation to combat established and emerging pathogens. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.
The Senior Director reports to an Executive Director in the Infectious Disease Clinical Research Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the infectious diseases therapeutic area. The individual would participate in all phases of clinical trial process (mainly Phase 2-5) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual would apply an in-depth understanding of the disease under study and drug/vaccine pharmacology to the Infectious Disease therapeutic area’s clinical development strategy and the implementation of short and long-term research objectives. They would provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders. In addition, a Senior Director may lead a Product Development Team, the cross-functional team responsible for end-to-end development and lifecycle management of new or marketed drugs, and will serve as the Clinical representative to this team.
Specifically, the Senior Director may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed infectious disease drugs
Planning clinical trials (design, operational plans) based on these clinical development strategies
Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Infectious Disease 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.
Presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones
In executing these duties, the Senior Director may:
Supervise the activities of Clinical Scientists or other Clinical Directors 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 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 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, including new scientific findings and research methodologies
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility
To accomplish these goals, the Senior Director may:
Author detailed development documents and presentations for internal and external audiences
Author scientific publications
Facilitate collaborations with external researchers around the world
Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects
M.D or M.D./Ph.D from a recognized school of medicine required, preferably with demonstrated expertise in Infectious Diseases subspecialty
Eligibility for medical licensure and board certification
Post graduate program yielding a PharmD degree with demonstrated expertise in clinical practice or clinical research may also be considered for the position
At least three years industry experience in clinical research and drug development. Consideration will be given to candidates with relevant governmental/regulatory agency experience or faculty in academia with experience leading large-scale clinical research activities
Demonstrated record of scientific scholarship and achievement
Experience in clinical medicine and background in biomedical research
Excellent communication skills, both verbal and written
Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.