Califesciences
Senior Principal Scientist, Clinical Research, HIV
Califesciences, South San Francisco, California, us, 94083
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.
Senior Principal Scientist 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 Scientific Knowledge
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
Accomplishing Goals
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, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Scientific Leadership, Scientific Publications, Scientific Research, Strategic Planning, Vaccine Research, Vaccinology
Preferred Skills Salary $276,600.00 – $435,400.00
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. We are proud to be a company that embraces value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.
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Senior Principal Scientist 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 Scientific Knowledge
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
Accomplishing Goals
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, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Scientific Leadership, Scientific Publications, Scientific Research, Strategic Planning, Vaccine Research, Vaccinology
Preferred Skills Salary $276,600.00 – $435,400.00
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. We are proud to be a company that embraces value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.
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