Research And Development Manager Jobs in Waterloo, ON

JOB PURPOSE

For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market position. Specifically, evidence must be maintained throughout the product lifecycle as standard of care changes, new competitors are introduced, and patents expire on existing competitors. The landscape is evolving quickly as trials demonstrating efficacy in an area of unmet need may receive expedited review, or orphan product status designation which affects both GSK and competitors launch timelines and approval requirements. More and more of our customers are developing sophisticated internal health outcomes capabilities and access to real world data that can be used to better understand unmet needs and real-world effectiveness of our medicines. We need to better understand how our customers define value and to effectively collaborate with them to ensure we are generating value evidence data that includes real world evidence and cost effectiveness analysis that is impactful for payers, health systems, providers, and patients.

The role of Director, Global Real-World Evidence & Health Outcomes Research Scientist is critical to achieving this ambition by supporting asset teams to ensure that each medicine GSK brings to market is supported by scientifically credible, high quality, evidence that drives competitiveness and strong evidence-based product positioning, value propositions and value-based pricing. The role is critical to support the alignment of evidence with evidentiary requirements of customers responsible for marketing authorization, recommendation and reimbursement leading to successful patient access, product use and commercial success.

The role will report directly into the Senior Director, Global Real-World Evidence & Health Outcomes Research for Hepatology therapeutic area and will have expertise in real-world evidence and other non-interventional study methods. The role will be a key member of asset team and other relevant matrix leadership teams. The Director, Global Real-World Evidence & Health Outcomes Research Lead Scientist for hepatology will be accountable for engaging closely with medical and matrix stakeholders and partner effectively in data generation plan (DGP) planning, design, execution, translation and dissemination at the study level for the asset.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Plan, design and execute multiple studies for a given asset and manage timelines, deliverables, and budget.

• Assure quality of deliverables, including review and sign off project specifications, protocols, data analysis plans, final study reports, abstracts, posters and manuscripts, adherence to SOPs.

• Identify resources, references and analyses to inform scientific design and advise internal experts (clinical, commercial/market access) and external experts as needed in support of the asset team.

• Translate identified needs for evidence into study concepts in alignment with strategic objectives and vision for the asset, e.g. development of study protocols and proposing innovative and cost-effective ways of developing and executing studies.

• Develop and maintain a good working knowledge of real-world data resources, existing partnerships and public initiatives and become the point person for select sources to advise on their suitability to address given research questions.

• Develop a deep understanding of customers' needs, including HTA requirements, as well as the of acceptance of RWE or economic evidence and impact to the decision making of different customers (reimbursement, medical societies, physicians).

• Collaborate with internal teams and participate in best practice sharing sessions across NIS organization.

• Build strong working relationships with stakeholder groups across medical, market access, R&D and commercial to ensure strategic alignment and optimal cross-functional collaboration and communication.

• Ensure key stakeholders including TA aligned business leaders are regularly updated on plans through periodic reporting.

• Develop excellent working relations with external thought leaders to ensure appropriate methods and research agendas are applied, in accordance with GSK policies.

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• MSc, or equivalent in health outcomes, health economics, epidemiology, pharmacy, health or life sciences.

• 3+ years' experience working in pharmaceutical industry, preferably in a multi-national company.

• Demonstrated ability to plan and deliver individual projects, manage budgets and work within matrix setting.

• A history of designing a variety of RWE studies including prospective observational studies, cross-sectional and retrospective cohort studies, chart reviews, and database analyses.

• Proficiency in utilizing evidence for the development of HTA submissions, reimbursement and/or medical engagements.

• A track record of delivering robust payer evidence and credibility to engage meaningfully with external experts and leaders in the field.

• Expertise with the diversity and complexity of healthcare markets, health technology assessment agencies, and reimbursement decision making globally, in region and local markets.

• Experience of how health economics, health outcomes, comparative effectiveness research and PRO research can be applied at local decision-making levels, including support of clinical practice.

• Experience in communicating technical and complex concepts and results effectively to various audiences to impact decision-making.

Preferred Qualifications
If you have the following characteristics, it would be a plus:

• Advanced scientific degree, e.g. PhD, PharmD or equivalent in Outcomes Research, Epidemiology or similar.

• Experience in above country and in country roles.

• Direct Payer experience.

• Launch experience.

What we value in you
You focus on patients and act with integrity. You explain technical findings in simple terms. You build trusted relationships and influence decisions respectfully. You are curious, pragmatic, and ready to learn. If this role excites you, we encourage you to apply and join us to create evidence that improves care for people with liver disease.

#LI-GSK

Skills

Cross-Functional Leadership, Digital Fluency, Enterprise Thinking, Evidence Based Decision Making, Flexible Mindset, High Impact Communication, Launch Excellence, Patient Journey If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $203,775 to $339,625. If you are based in another US location, the annual base salary range is $185,250 to $308,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Belgium Salary Range / Fourchette salariale - Belgique: EUR 122,250 to EUR 203,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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