Senior Principal Scientist, Clinical Research, HIV

Job Description

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:

• 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.

The Senior Principal Scientist 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 Principal Scientist will:

• 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.

Qualifications

Education:

• MD or MD/PhD with demonstrated expertise in infectious diseases; eligibility for medical licensure and board certification desirable

Requirements:

• 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

Preferred:

• Background in antiviral clinical research and HIV drug development

• Prior experience with registrational trials and filing with major health authorities

Required Skills:

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, In