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 analysesregulatory reporting and individual will apply an in-depth understanding of HIV and drug pharmacology to the infectious disease therapeutic areas clinical development strategy and the implementation of short and long-term research 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 companys 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:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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