Director, US Real World Evidence Center of Excellence

Kite Pharma • Santa Monica, CA

1d

About The Position

We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director, Medical Affairs, US Real World Evidence Center of Excellence is responsible for leading Kite’s evidence generation strategy and execution in several key areas: (1) post-marketing requirement (PMR) registries for the US and countries with similar registry systems, (2) epidemiological expertise to support pipeline planning as well as US safety and pharmacovigilance activities, (3) development of strategically aligned scientific publications using real-world evidence (RWE), and (4) leadership of specialized analyses of real-world data, including registries, claims, and electronic health records, to support RWE studies. The Director manages a team of 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. The Director 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.

Requirements

• Advanced scientific degree (i.e., MD, PharmD, PhD) and 8+ years of biotech/pharmaceutical industry experience OR Master’s Degree and 10+ years of biotech/pharmaceutical industry experience OR Bachelor’s Degree and 12+ years of biotech/pharmaceutical industry experience

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 team’s 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. BLA, sBLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, 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)

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees