Director, Real World Evidence Center of Excellence

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

As Director Medical Affairs Real World Evidence Center of Excellence you will be responsible for leading Kites evidence generation strategy and execution in several key areas:

-marketing requirement (PMR) registries for the Australia/Canada/Europe (ACE) and Intercontinental (ICR) regions.

2. Epidemiological expertise to support pipeline planning as well as ACE and ICR safety and pharmacovigilance activities

3. Development of strategically aligned scientific publications using real-world evidence (RWE)

4. Leadership of specialized analyses of real-world data including registries claims and electronic health records to support RWE studies.

You will also manage epidemiologists and data analysts engaged in RWE studies. The role also entails collaboration with the cross-functional team including Clinical Medical Safety Commercial Research and Technical Operations to identify and lead strategically aligned projects where RWE can support organizational objectives including regulatory and technical initiatives pipeline acceleration and patient access.

You will also serve as a leader of RWE in scientific forums and collaborate with external physicians scientists and researchers as well as alliance partners on RWE activities.

Additional responsibilities

• Leading study concept development and execution of incidence/prevalence burden of illness and natural history of disease assessment for business and development and early development indications

• Strategic and tactical support for cross-functional RWE development including registries burden of illness/natural history of disease for regulators payers and clinicians

• Providing leadership and oversight of non-interventional study protocols regulatory documents and scientific publications

• Provide excellent people leadership to team members including fostering a candid constructive feedback culture cultivating the teams development and identifying and investing in succession planning

• Adapt performance metrics and dashboards for RWE projects to quantify and enhance impact

• Provide expertise on RWE and observational research to cross functional teams including brand strategy teams for assigned brand/pipeline newly launched and marketed product(s)

• Assess research gaps and objectives across key partners and disease areas to determine proactive RWE/observational research strategy

• Possess superb communication skills with adaptability to address technical and non-technical audiences and comprehensive understanding of strategies to translate observational research methods and results for patient benefit

• Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research

• Provide RWE expertise and input for regulatory filings (e.g. MAA BLA sBLA) as well as response to questions from regulatory authorities in the context of clinical trial applications clinical trial applications filing procedures or pharmacovigilance/safety inquiries.

• Develop execute and deploy integrated evidence generation plans develop contingency plans provide technical and strategic advice and meet milestones and budgets

• Provide RWE leadership in scientific forums and interact with clinical investigators and thought leaders external stakeholders (medical experts advisory boards patient advocacy groups) and internal stakeholders (Research Translational Sciences Clinical Operations Safety Regulatory Medical Affairs and Commercial)

Your profile

• Doctoral degree (e.g. PhD MD ScD PharmD) in Epidemiology or related discipline such as Outcomes Research Medicine Biostatistics from an accredited institution with a minimum of 8 years of relevant post-graduation experience with doctoral training OR

• Masters degree (e.g. MSc) in Epidemiology or related discipline such as Outcomes Research Medicine Biostatistics from an accredited institution with 10 years of relevant experience with Masters training

• Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry.

In addition experience with Post Marketing Requirement (PMR) registries is highly preferable.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.