Director, US Real World Evidence Center of Excellence

仕事内容

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.

Specific duties include:

• 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)

Basic Qualifications

• 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

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.