Director, RWE Virology Safety Epidemiology

Gilead Sciences; Greater London; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced RWE Safety Research Lead in Greater London. The role involves executing safety studies and leading a team of scientists in Virology. Candidates should have a doctoral or master's degree in Epidemiology or a related discipline and significant experience in the biopharmaceutical industry. This is an opportunity to work within a dynamic and collaborative environment aimed at tackling major health challenges.

Qualifications

• Minimum of 8 years of relevant post-graduation experience with doctoral training.
• Minimum of 10 years of relevant experience with Masters training.
• Experience designing and conducting observational research.

Responsibilities

• Responsible for the development and execution of specified RWE safety studies.
• Lead a team of observational research scientists.
• Communicate observational research results effectively.

Skills

Strong preference for expertise in state-of-the-art methods including AI / ML approaches

Ability to communicate proactively

Well-developed cross-cultural sensitivity

Education

Doctoral degree in Epidemiology or related discipline

Masters degree in Epidemiology or related discipline

Job description

Job Description

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

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.
• Collaborates and coordinates 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.
• Communicates 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.
• Masters 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 Masters 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 receive 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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non‑discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.