Senior/Principal PCOR Scientist

Published
July 29, 2022
Location
South San Francisco, CA
Category
Job Type

Description

The Position

Today only a fraction of humanity receives the best healthcare. There are many reasons why effective and efficient healthcare may not be available to all, why the latest innovations are not widely adopted and integrated into care, why tailored care plans are not always accessible. But one thing is certain: humanity deserves better. The focus needs to broaden-from treating disease...to delivering patient-centered healthcare.

At Roche, personalised healthcare (PHC) means better health, at a lower cost, for people and society. It means shifting from a one-size-fits-all approach to the best care for each person. The convergence of pioneering science, data, analytics and technology-existing and new-is central to this vision. When data become insights, systems learn. The care experience and health outcomes improve. People benefit.

The Senior/Principal PCOR Scientist is a Data Scientist responsible for the development and/or strategic execution of patient-centered fit-for purpose measurement strategies throughout the drug development lifecycle. This includes assessing the need to develop, evaluate, and/or successfully deploy new measurement tools to best capture the patient experience. The Senior/Principal PCOR scientist is responsible for the complex and visible priority projects and accountability may extend to representation of all Data Science functions on global development teams and other cross-functional expert groups. The Senior/Principal PCOR Scientist may have responsibilities on product-level evaluations, however, this generally will extend to a portfolio within a disease area or across disease areas with similar etiology, assessments or outcomes. Additionally, this may span across therapeutic areas and/or functional tracks dependent on the individual development plan and business needs. The Senior/Principal PCOR Scientist may also have responsibility for vendor management, participation in SME teams, and serve as the PCOR Lead for internal and external transformative activities.

Accountabilities:

Clinical Development/Non-Clinical Development Senior/Principal PCOR Scientists are Members of the Genentech/Roche Data Scientist Family that are uniquely responsible for:

  • Expertise in evaluating patient-relevant evidence to support decision making: accountable to develop/communicate PCOR evidence/execution strategic plans, PCOR inputs into key strategic documents including (but not limited to) target product profiles and integrated evidence plans; serves as lead PCOR scientist on cross-functional study management teams or on early development project teams or a portfolio enabling project. May be the PCOR Scientist on priority products/portfolios that are complex and/or highly visible.
  • Provides or supervises PCOR strategy and content for required documentation for: portfolio/disease area /therapeutic area, may lead/consult on study development (e.g. endpoints), study execution (e.g. data collection/monitoring plan, SAPs, CSRs), regulatory activities (meetings, filings, label negotiation), and leads collaborations with teams responsible for market access and successful commercialization to ensure seamless links.
  • Study Conduct: ensures PCOR endpoints are adequately captured and accurate, serves as SME for developing solutions to complex scientific/technical problems related to measurement tools, clinical trial delivery, and technologies.
  • Is a subject matter expert in one or more areas of clinical trial delivery (measurement/digital strategy, linguistic validation, eCOA, site and patient engagement related to COA).
  • Leads dissemination of PCOR-related content and activities (e.g. manuscripts, conference abstract/presentations)
  • May supervise or conduct psychometric/ statistical analyses.
  • Leads in design and evaluation of emerging technology with potential use in research activities to ensure relevance as a patient-centered measurement tool.
  • Provides expert advice or participates in high visibility projects: experimental design, data capture and analysis for non-clinical projects (e.g. registries, observational studies, FAIR Data initiatives), is a leader in establishing best practices and innovation within the field.

Functional Area:

  • Understands and applies business requirements/objectives and when relevant, is able to identify solutions for transformation.
  • Leads/mentors/coordinates the development of functional training and/or cross-functional training workshops.
  • Advisor on one or more: COA selection, development, validation, clinically meaningful change, technology assessment, strategy execution including deployment of measure, data attainment and issue identification and resolution. Leads new developments in measurement science, outcomes measurement and drug development.
  • Contributes to the development of industry-wide guidelines (or similar documents) issued by external bodies.
  • Manages collaborations with external academics, biotech or industry-wide research organizations.
  • Is active and sought out mentor in both informal/formal programs.

Qualifications & Competencies:

  • Advanced Degree (MPH, MSc, PharmD or PhD in Outcomes Research, Public Health, Psychometrics, Epidemiology, Allied Health, Psychology) or similar areas OR substantial expertise in relevant/target areas.
  • Successful demonstration of qualitative or quantitative research conduct: surveys, endpoint development, instrument development and validation, COA execution, clinical trial design, early strategy development, psychometric/quantitative leadership or launch experience is desired.
  • Good knowledge of English in a business environment.
  • Understands and applies business requirements and processes.
  • Good understanding of regulatory guidelines in a pharmaceutical research setting.
  • Good project management skills: ability to manage scope, delegation, timelines, vendor performance.
  • Understands and respects cultural differences when interacting with colleagues globally.
  • Expertise in strategic agility that extends beyond PCOR aspects of drug development.
  • Results driven: interest and ability to learn new things, is solution oriented.
  • Effective mentoring of PCOR Scientists.

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

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