Senior Principal Scientist, Clinical Research, HIV

Merck & Co.•North Wales, PA

44d•Hybrid

About The Position

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. Since 1985, our company has been engaged in research and development efforts in the prevention and treatment of HIV. Over the years, our scientists have made significant discoveries that changed the way HIV is treated. 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 Principal Scientist has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the HIV section of the infectious diseases therapeutic area. The individual will participate in all phases of clinical trial process (mainly Phase 2-3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual will apply an in-depth understanding of HIV and drug pharmacology to the infectious disease therapeutic area's clinical development strategy and the implementation of short and long-term research objectives. They will provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders. Specifically, the Senior Principal Scientist is responsible for:

Requirements

MD or MD/PhD with demonstrated expertise in infectious diseases; eligibility for medical licensure and board certification desirable
Industry experience in clinical research and drug development (at least 5 years)
Demonstrated success in overseeing clinical studies and protocols
Demonstrated record of scientific scholarship and achievement
Excellent communication skills, both verbal and written
Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
Clinical Development
Clinical Judgment
Clinical Medicine
Clinical Research Management
Clinical Trial Development
Clinical Trials
Data Analysis
Drug Development
HIV Prevention
Infectious Disease
Infectious Disease Research
Intellectual Curiosity
Interdisciplinary Problem Solving
Medical Research
Pharmacovigilance
Regulatory Compliance
Regulatory Reporting
Scientific Leadership
Scientific Publications
Scientific Research
Strategic Planning
Vaccine Research
Vaccinology

Nice To Haves

Background in antiviral clinical research and HIV drug development
Prior experience with registrational trials and filing with major health authorities

Responsibilities

Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed HIV drugs
Monitoring and managing the conduct of ongoing or new clinical trials
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, and publications
Participating in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs.
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.
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.