Gilead Sciences
Director, RWE Virology Safety Epidemiology
Gilead Sciences, San Francisco, California, United States, 94199
Director, RWE Virology Safety Epidemiology
Join the Director, RWE Virology Safety Epidemiology role at
Gilead Sciences .
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We are open to candidates at Foster City, Cambridge (UK), or Stockley Park (UK).
Duties & Responsibilities
Responsible for the development, execution, and communication of specified RWE safety/non‑experimental studies for individual products and their pipeline/lifecycle indications in Virology.
Provide functional perspective and subject‑matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of RWE safety and PAS protocols and analysis plans developed internally and externally.
Collaborate and coordinate safety, pediatrics, and PAS activities with RWE Virology Product teams.
Employ robust scientific methods for the timely execution of safety, pediatrics, and PAS strategy in alignment with pipeline/lifecycle management objectives.
Lead or contribute to a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, RWE safety/PAS including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post‑approval safety studies.
Communicate effectively about the utility of RWE across the product lifecycle and contribute to the use of study results to support internal and external decisions.
Communicate observational research results, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
Represent the RWE function in internal cross‑functional teams and initiatives.
Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, Medical Affairs and Global Value and Access, to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
Identify the need for and contribute directly to the development of processes and delivery of training documents aimed at increasing the efficiency, quality, and impact of functional activities.
Mentor junior epidemiologists to ensure competence in epidemiologic skills and knowledge.
Requirements
Doctoral degree (e.g. PhD, MD, ScD, PharmD) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8+ years of relevant, post‑graduation experience with doctoral training OR
Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with 10+ years of relevant experience with Master’s training
Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry.
Preference for understanding of the Virology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
Strong preference for expertise in state‑of‑the‑art methods, including AI/ML approaches, for leveraging RWD to assess safety and other questions.
Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
Solid working knowledge of global regulatory guidelines pertaining to RWD and RWE studies, especially PAS.
Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different applications of RWE, especially in support of PAS.
Experience managing vendor relationships, leading studies, projects and people in a matrix setting.
Demonstrated ability to function with autonomy and develop productive cross‑functional collaborations.
Ability to manage priorities, resources, and performance targets, in a changing environment.
Well‑developed cross‑cultural sensitivity.
People Leader Accountabilities
Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent – understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Compensation and Benefits The salary range for this position is: $226,185.00 – $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Equal Employment Opportunity Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr
Gilead Sciences .
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We are open to candidates at Foster City, Cambridge (UK), or Stockley Park (UK).
Duties & Responsibilities
Responsible for the development, execution, and communication of specified RWE safety/non‑experimental studies for individual products and their pipeline/lifecycle indications in Virology.
Provide functional perspective and subject‑matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of RWE safety and PAS protocols and analysis plans developed internally and externally.
Collaborate and coordinate safety, pediatrics, and PAS activities with RWE Virology Product teams.
Employ robust scientific methods for the timely execution of safety, pediatrics, and PAS strategy in alignment with pipeline/lifecycle management objectives.
Lead or contribute to a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, RWE safety/PAS including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post‑approval safety studies.
Communicate effectively about the utility of RWE across the product lifecycle and contribute to the use of study results to support internal and external decisions.
Communicate observational research results, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
Represent the RWE function in internal cross‑functional teams and initiatives.
Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, Medical Affairs and Global Value and Access, to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
Identify the need for and contribute directly to the development of processes and delivery of training documents aimed at increasing the efficiency, quality, and impact of functional activities.
Mentor junior epidemiologists to ensure competence in epidemiologic skills and knowledge.
Requirements
Doctoral degree (e.g. PhD, MD, ScD, PharmD) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8+ years of relevant, post‑graduation experience with doctoral training OR
Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with 10+ years of relevant experience with Master’s training
Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry.
Preference for understanding of the Virology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
Strong preference for expertise in state‑of‑the‑art methods, including AI/ML approaches, for leveraging RWD to assess safety and other questions.
Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
Solid working knowledge of global regulatory guidelines pertaining to RWD and RWE studies, especially PAS.
Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different applications of RWE, especially in support of PAS.
Experience managing vendor relationships, leading studies, projects and people in a matrix setting.
Demonstrated ability to function with autonomy and develop productive cross‑functional collaborations.
Ability to manage priorities, resources, and performance targets, in a changing environment.
Well‑developed cross‑cultural sensitivity.
People Leader Accountabilities
Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent – understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Compensation and Benefits The salary range for this position is: $226,185.00 – $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Equal Employment Opportunity Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr