Basic Function: The Principal RWD Scientist is responsible for providing RWD expertise, strategic input and leadership to Product Development, Global and Local Medical Affairs, Global Pricing and Market Access, and Mature Products. The Senior RWD Scientist is accountable for the scientific rigor of the RWD applications across the lifecycle of the programs.
The Principal RWD Scientist typically represents RWDS on global development teams and global medical affairs teams, partnering with scientists in clinical, safety, biostatistics, regulatory, medical affairs, payer strategy, and MORSE. The Principal RWD Scientist accountabilities typically extend to leading the RWDS Disease Area Team.
A member of global cross-functional teams and sub-teams (e.g. GDT, GMAT, Safety).
Typically the leader of one or more RWDS Disease Area Teams and leads RWD strategy for an indication across multiple programs
Provide strategic input and RWDS expertise into the CDP, TPP, AMP, and ABP.
Understands strategy and needs in development, medical affairs and patient access and provides RWD solutions to address evidence gaps.
Responsible for the scientific rigor of the RWD studies, regulatory submissions and HTA submissions within the disease areas.
Oversees the deliverables from RWD CROs.
May serve as the RWD Scientist on the cross-functional study team for RWD studies, with the incumbent responsibilities and accountabilities.
Recognized expertise in RWD science methods and their application. Provide consultation within and outside of own projects.
Engages in research and development of RWD science methodology in alignment with current project needs and future trends of RWDS
Maintain knowledge of RWD sources for therapeutic area
Leads RWDS and cross-functional initiatives
Mentors RWD Scientists and Analysts
Who You Are
Excellent understanding of private and public real-world data sources
Excellent knowledge and experience in design, implementation and reporting of real-world data studies in the pharmaceutical industry
Excellent knowledge of international regulatory and ICH GCP guidelines.
Understands and applies business requirements and processes
Understands and respects cultural differences when interacting with colleagues in the global work place
Largely autonomous to accomplish responsibilities
Excellent communication and collaborations skills (including interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)
Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors, and external vendors)
Excellent strategic ability (including problem-solving and critical thinking skills, ability to drive drug development and patient access strategies, agility that extends beyond RWD expertise)
Excellent drive for results (demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
Proficient mentoring of (Associate) RWD Scientists
Background/Experience and Education:
MSc or PhD in Epidemiology, Outcomes Research, Statistics, Biostatistics, Mathematics or similar areas of academic discipline. Background/experience in Genetics desirable.
Good knowledge of English in a business environment.
Programming experience with SAS or/and other statistical software packages desirable
Experience with digital health, or, biomarkers, or, scientific projects involving advanced analytics applications (eg machine learning tools) desirable.
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.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.