VP Head of Real World Evidence at Gilead Sciences Foster City, CA
Job Description Reporting to the SVP of Data Sciences and Biometrics, the Head of Real World Evidence will lead the expansion of the Epidemiology organization from a focus on post-authorization safety studies to also encompass the use of real world evidence to support decision-making across Company's pipeline.
In this capacity, the individual will oversee an increase in the direct and in-direct resources dedicated to building out an industry-leading real world evidence capability.
Through this individual's leadership, the expanded Real World Evidence organization will collaborate with cross-functional and cross-therapeutic groups broadly and provide input into real world evidence generation strategies and observational study designs to support Company's pipeline and life cycle management strategy.
This role is an influential leader within the company, championing appropriate methodological approaches and study designs, driving the institution of best practices with regard to the planning, execution, and interpretation of observational studies.
In particular, the use of real world data to build comparator cohorts supporting single-arm trials has increased in the pharmaceutical industry.
In their role as Head of Real World Evidence, this individual will be jointly accountable with the VP of Biostatistics for the rigorous design of a combined clinical trial and observational study evidence generation plan that demonstrates the value of Company's medicines.
The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic approaches to observational research, as well as demonstrated motivation for and excellence in people management and development.
Core
Responsibilities:
Strategic Thinking:
Aligns with Clinical Development senior leadership to define and implement a technically advanced cross functional real world evidence strategy to support our development and life cycle management needs; Maintains a broad understanding of relevant external global trends, anticipating emerging issues relevant to the department, identifying strategic needs in technical knowledge and setting the strategic direction for the department to meet regulatory, scientific and business needs.
Innovation:
Keeps up to date on industry-leading RWE platforms, common data models (CDMs), distributed data networks and collaboration models (ex OHDSI) and RWE data sciences by actively participating in technical meetings and maintaining relationships with external innovators to constantly bring the best solutions to CompanyDelivery Excellence:
Builds and develops an expert team of epidemiologists and real world data researchers to support goals across therapeutic areas; Leads an assessment of Company's current real world evidence capabilities and strengths and develops a roadmap for building additional capabilities where needed; Ensures the execution and integrity of protocols, statistical analysis plans, study reports and presentations and publications of observational studies by applying your past experiences and providing leadershipAdditional
Responsibilities:
Influence and Partnership:
Enables data-driven decision making within Company Clinical Development to increase the impact of existing programs; Creates external relationships with academic and industry experts in order to stay abreast of emerging technologies; Identifies, selects and develops partners, including vendors and collaborators (both academic and industry), ensuring alignment with the overall vision of R&D and identifying cross functional benefitsPeople Development:
Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others.
Decision-making:
Maintains a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makersCommunication:
Champions the Biostatistics function across all areas of the business; Creates excitement and passion for the role of Real World Evidence to inform decisions across the organizationCapabilities and Requirements:
Responsibilities will include, but are not limited to, the followingBuild and manage an industry-leading real world evidence team and capability at CompanyAccountable for ongoing support of Company's post authorization safety studies, Risk Evaluation Management Systems (REMS), regulatory agency requests and related lifecycle management activitiesWorks closely with Medical Affairs to establish a partnership model on the design and execution of voluntary post authorization studiesAccountable for the ongoing evolution of Company's data governance policies and procedures for secondary use of observational dataIn collaboration with Clinical Development functions, works across and within therapeutic areas to develop and execute on a proactive real world data acquisition strategy to support the Company's portfolioJointly accountable with the VP of Biostatistics for the rigorous design of a combined clinical trial and observational study evidence generation plan for any clinical trials supported by real world evidence cohortsContributes to the IT and platform strategy for the support of real world data awareness,acquisition, integration and analysis across Company.
Advises and influences senior leadership/functional leads on real world evidence generation strategies as well as functional issues that have a business impact.
Provides leadership, guidance and management to real world evidence support across therapeutic areas to ensure high quality and timely deliverables.
Champions the creation/maintenance of training on observational research topics and departmental SOPs, Policies and Business Enablement Documents.
Represents the company in interfaces with regulatory agencies globally.
Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses.
Represents Company at professional societies, and in industry-wide technical discussions.
Identifies external experts for consultation.
Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities.
Interacts and manages KOLs/CROs and represents the company in external scientific forums.
Provides guidance to employees' development plans and carries out performance review and feedback.
Provides active coaching to Real World Data team members when developing solutions to problems.
Builds a professional and effective real world evidence community that is seen as a business asset, strategic partner and attracts, develops and retains top talentEducation and
Qualifications:
PhD in Epidemiology, Health Economics, Biostatistics, Statistics or related field15
years of experience working in a Biotech/Pharma R&D business functionLeadership and build experience across a global Epidemiology or Real World Evidence function in a pharmaceutical environmentDirect experience engaging with regulatory agencies on the use of real world evidence in support of pharmaceutical development and lifecycle managementDemonstrated skill in the planning, analysis and reporting of prospective and retrospective observational studies in a pharmaceutical environmentDetailed knowledge of observational methodologies and regulatory requirements around its use to support regulatory filings and post-authorization activitiesIn-depth knowledge of all clinical phases of the global drug development processDemonstrated ability to work in a team environment with clinical team membersDemonstrated skill in resource planning and managementDemonstrated ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functionsExcellent oral and written communication skills, including the ability to translate between business leaders, scientists and technologistsPersonal ProfileYou are a natural leader and specialist in Epidemiology and/or observational research who can bring teams closer together and architect the common use of epidemiological methodology in a variety of therapeutics areasYou can create excitement and passion for the role of Biostatistics across the organizationYou are a reputable expert in building real world evidence functions who enjoys debating in novel methodologies, is persuasive and trusted by senior leadership teamsYou have strong interpersonal skills who is able to create collaborative relationships companywide and support individuals with their specific needsYou are a champion of the long-term vision for Real World Evidence and its partnership with Biostatistics, Data Sciences, Bioinformatics and other analytics disciplines within Company.
Estimated Salary: $20 to $28 per hour based on qualifications.
In this capacity, the individual will oversee an increase in the direct and in-direct resources dedicated to building out an industry-leading real world evidence capability.
Through this individual's leadership, the expanded Real World Evidence organization will collaborate with cross-functional and cross-therapeutic groups broadly and provide input into real world evidence generation strategies and observational study designs to support Company's pipeline and life cycle management strategy.
This role is an influential leader within the company, championing appropriate methodological approaches and study designs, driving the institution of best practices with regard to the planning, execution, and interpretation of observational studies.
In particular, the use of real world data to build comparator cohorts supporting single-arm trials has increased in the pharmaceutical industry.
In their role as Head of Real World Evidence, this individual will be jointly accountable with the VP of Biostatistics for the rigorous design of a combined clinical trial and observational study evidence generation plan that demonstrates the value of Company's medicines.
The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic approaches to observational research, as well as demonstrated motivation for and excellence in people management and development.
Core
Responsibilities:
Strategic Thinking:
Aligns with Clinical Development senior leadership to define and implement a technically advanced cross functional real world evidence strategy to support our development and life cycle management needs; Maintains a broad understanding of relevant external global trends, anticipating emerging issues relevant to the department, identifying strategic needs in technical knowledge and setting the strategic direction for the department to meet regulatory, scientific and business needs.
Innovation:
Keeps up to date on industry-leading RWE platforms, common data models (CDMs), distributed data networks and collaboration models (ex OHDSI) and RWE data sciences by actively participating in technical meetings and maintaining relationships with external innovators to constantly bring the best solutions to CompanyDelivery Excellence:
Builds and develops an expert team of epidemiologists and real world data researchers to support goals across therapeutic areas; Leads an assessment of Company's current real world evidence capabilities and strengths and develops a roadmap for building additional capabilities where needed; Ensures the execution and integrity of protocols, statistical analysis plans, study reports and presentations and publications of observational studies by applying your past experiences and providing leadershipAdditional
Responsibilities:
Influence and Partnership:
Enables data-driven decision making within Company Clinical Development to increase the impact of existing programs; Creates external relationships with academic and industry experts in order to stay abreast of emerging technologies; Identifies, selects and develops partners, including vendors and collaborators (both academic and industry), ensuring alignment with the overall vision of R&D and identifying cross functional benefitsPeople Development:
Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others.
Decision-making:
Maintains a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makersCommunication:
Champions the Biostatistics function across all areas of the business; Creates excitement and passion for the role of Real World Evidence to inform decisions across the organizationCapabilities and Requirements:
Responsibilities will include, but are not limited to, the followingBuild and manage an industry-leading real world evidence team and capability at CompanyAccountable for ongoing support of Company's post authorization safety studies, Risk Evaluation Management Systems (REMS), regulatory agency requests and related lifecycle management activitiesWorks closely with Medical Affairs to establish a partnership model on the design and execution of voluntary post authorization studiesAccountable for the ongoing evolution of Company's data governance policies and procedures for secondary use of observational dataIn collaboration with Clinical Development functions, works across and within therapeutic areas to develop and execute on a proactive real world data acquisition strategy to support the Company's portfolioJointly accountable with the VP of Biostatistics for the rigorous design of a combined clinical trial and observational study evidence generation plan for any clinical trials supported by real world evidence cohortsContributes to the IT and platform strategy for the support of real world data awareness,acquisition, integration and analysis across Company.
Advises and influences senior leadership/functional leads on real world evidence generation strategies as well as functional issues that have a business impact.
Provides leadership, guidance and management to real world evidence support across therapeutic areas to ensure high quality and timely deliverables.
Champions the creation/maintenance of training on observational research topics and departmental SOPs, Policies and Business Enablement Documents.
Represents the company in interfaces with regulatory agencies globally.
Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses.
Represents Company at professional societies, and in industry-wide technical discussions.
Identifies external experts for consultation.
Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities.
Interacts and manages KOLs/CROs and represents the company in external scientific forums.
Provides guidance to employees' development plans and carries out performance review and feedback.
Provides active coaching to Real World Data team members when developing solutions to problems.
Builds a professional and effective real world evidence community that is seen as a business asset, strategic partner and attracts, develops and retains top talentEducation and
Qualifications:
PhD in Epidemiology, Health Economics, Biostatistics, Statistics or related field15
years of experience working in a Biotech/Pharma R&D business functionLeadership and build experience across a global Epidemiology or Real World Evidence function in a pharmaceutical environmentDirect experience engaging with regulatory agencies on the use of real world evidence in support of pharmaceutical development and lifecycle managementDemonstrated skill in the planning, analysis and reporting of prospective and retrospective observational studies in a pharmaceutical environmentDetailed knowledge of observational methodologies and regulatory requirements around its use to support regulatory filings and post-authorization activitiesIn-depth knowledge of all clinical phases of the global drug development processDemonstrated ability to work in a team environment with clinical team membersDemonstrated skill in resource planning and managementDemonstrated ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functionsExcellent oral and written communication skills, including the ability to translate between business leaders, scientists and technologistsPersonal ProfileYou are a natural leader and specialist in Epidemiology and/or observational research who can bring teams closer together and architect the common use of epidemiological methodology in a variety of therapeutics areasYou can create excitement and passion for the role of Biostatistics across the organizationYou are a reputable expert in building real world evidence functions who enjoys debating in novel methodologies, is persuasive and trusted by senior leadership teamsYou have strong interpersonal skills who is able to create collaborative relationships companywide and support individuals with their specific needsYou are a champion of the long-term vision for Real World Evidence and its partnership with Biostatistics, Data Sciences, Bioinformatics and other analytics disciplines within Company.
Estimated Salary: $20 to $28 per hour based on qualifications.
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