Principal Outcomes Research Scientist

Job description

  Job facts

Roche Canada is advertising a unique opportunity to join the Patient Oriented Outcomes research team. In this new role to our Mississauga site offers an opportunity to be part of a true global team.

The Principal Outcomes Research Scientist (PORS) is responsible for providing expertise and strategic leadership in the development of patient-centered and fit-for-purpose measurement strategies, and the execution of pre-approval and post-approval drug development programs across Roche.

The impact you will make in this role:

·  Provide strategic input across multiple pipeline and marketed medicines
·  Collaborate with clinical development teams, lifecycle teams and access teams
·  Generate data and strategies to unlock the value and demonstrate the benefit of Roche products.
·  Develop conceptual models, validate clinical outcome assessments (COAs).
·  May also influence the external environment by contributing to and leading initiatives such as C-Path, ISOQOL, ISPOR, DIA Duke Margolis, etc.
·  You will impact the PCOR/Biometrics function and therapeutic area beyond an individual project and will be seen as thought leader within the company.
·  You will lead high-impact and broad initiatives and partner with relevant managers to help determine and develop the technical/strategic capabilities needed to ensure functional excellence.

For a detailed description of tasks and accountabilities, please see below:

Clinical Development & Patient Access:

·  Act as PCOR functional lead on various teams including Global Development Teams, Lifecycle Teams and Clinical Teams.
·  Study Planning: Provide strategic leadership on endpoints and strategies for evidence generation. Reviews study protocols, inputs on COA-related sections of statistical analysis plans. Act as cross-functional reviewer on strategies and deliverables.
·  Analysis and Reporting: Strategic input/review of clinical study reports and target product profiles.
·  Strategic oversight and input of PCOR-related content and activities e.g. manuscripts, conference abstracts/presentations.

Functional Area:

·  Understand and apply business requirements and processes. Leads functional training.
·  Keep abreast of new developments in patient-centered outcomes research, drug development, and regulatory guidance.
·  Leads PCOR and cross-functional initiatives. Leads the development of functional processes.
·  Recognized expertise in COA selection, development, validation and demonstration of clinically meaningful change.
·  Builds and maintains excellent collaborative relationships and partnerships with key TA colleagues to effectively consider strategic approaches to drug development, clinical trials, and to meet operational requirements of development plans within the TA (this includes but is not limited to PD functions, as well as GPS, GPMA, key affiliates (US/Genentech, UK and Germany).
·  Acts as functional lead on development and revision of guidances and other similar documents when issued by external bodies (e.g. FDA, EMA, Other Global Regulatory bodies, Health Technology Assessment bodies, etc.).
·  Leadership of key external initiatives that increase the success of our molecule programs (e.g. C-Path, Duke Margolis, ISOQOL, ISPOR, FoCR).
·  Deliver and shape the PCOR vision to generate patient-relevant information through collaboration across the organization spanning early development through post-approval phases.

People Development and Management:

·  Mentor and support other scientists.

For a detailed list of ideal background, please see below:

Qualifications and Knowledge:

·  Advanced degree in Outcomes Research, Public Health, Psychometrics, Psychology or similar areas of academic discipline, or significant expertise in target area.
·  Significant experience conducting qualitative or quantitative research, survey research, and endpoint development.
·  Develops solutions to problems of unusual complexity which require a high level of ingenuity, creativity, and innovativeness.
·  Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors).
·  Excellent strategic agility (including problem-solving and critical thinking skills, ability to drive novel measurement strategies, agility that extends beyond PCOR elements of drug development).
·  Demonstrated interest and ability to learn new things; takes initiative, welcomes problems as challenges, finds solutions to technical problems, interpersonal challenges, and drives change.
·  Ability to build and foster strong collaborative networks of internal and external partners across sites, functional areas, and business units, and outside Roche.
·  Ability to shape and champion processes and practices to ensure functional norms and best practices are being uniformly applied.
·  Understanding and respect of cultural differences when interacting with colleagues in the global work place.
·  Ability to mentor and coach others.
·  Demonstrated ability to lead complex teams and projects with high impact
·  Strong knowledge of English in a business environment.
·  Pharmaceutical or biotechnology background is highly desired.

Qualified candidates are encouraged to apply by: October 10, 2018

This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.

NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Roche is an equal opportunity employer.
Access, Access > Health Technology Assessment

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.