Senior Director, Real World Evidence

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 20, 2019
Ref
R0009913
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Senior Director Real World Evidence

This role will be responsible for the overall Real-World Evidence strategy for Kite and will be tasked with building relevant organizational capabilities and infrastructure to enable the organizational vision of becoming a leader in real world evidence generation and utilization. This role will report to the Global Head of Medical Affairs for Oncology and Cell Therapy and will be a member of the Oncology and Cell Therapy Medical Affairs Leadership Team. The role will be based in Kite's Headquarters in Santa Monica, CA

Responsibilities (include but are not limited to):

Assess research gaps and develop the real-world evidence (RWE) strategy for Kite's portfolio of cellular therapy.

Work closely with the cross-functional teams from research, development, medical affairs, regulatory, safety and market access to ensure that the RWE strategy optimally addresses current and future needs and positions Kite as a leader in RWE generation.

Build consensus across regulatory, biostatistics, global medical affairs, development, translational, global HEOR, Market Access, and patient access to ensure timely delivery of scientifically valid epidemiologic and observational research in indications relevant to Kite's portfolio.

Cross-functional collaboration to develop RWE historical controls, incidence/prevalence, burden of illness, and natural history of disease studies to fulfill multiple business needs

Utilize RWE data to inform medical affairs strategy, support differentiation of Kite portfolio, address clinical and scientific data gaps.

Inform clinical trials program and medical education efforts.

Support appropriate patients access to our innovative therapeutics via generation of robust scientific evidence.

Define appropriate data sources and study designs in support of overall RWE strategy.

Work collaboratively with different regions to guide and inform regional and local RWE plans in alignment with global strategy.

Assess real world data assets available for procurement and establish real world data plan, including data licenses and data platforms, in collaboration with governance committee

Co-leads the creation of the integrated evidence generation plans with Health Economics and Outcomes Research and global medical affairs asset leaders.

Train and coach internal stakeholders across functions on RWE and communicate the strategy and tactics as appropriate.

Qualifications & Experience:

10+ years Medical Affairs experience at pharmaceutical companies, academia or payer

One or more of the following advanced degrees in life sciences: Epidemiologist, MD, DO, PharmD, or PhD;

5+ year's clinical experience in hematology oncology therapeutic areas is preferred

Deep understanding of epidemiological study design, observational research, and collaborative registries

Strong understanding of Medical Affairs and Health Economics Outcomes Research

Experience in working closely with quantitative scientists and biostatisticians

Considerable experience in planning, creating, and analyzing real-world data, including utilizing or establishing databases, registries, consortium and institutional and other data sources; and research and statistical methodology for prospective and retrospective studies

Strategic thinking skills with demonstrated ability to successfully lead the ideation, development of a plan and move to action;

Demonstrated success managing teams (directly or indirectly) across global matrix organizations

A willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment

Existing global contacts with hematology institutions and/or hospitals strongly preferred

Solid working knowledge of regulatory and compliance environment

Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences

Computer proficiency in all common IT work tools

Ability to travel frequently (+/- 30%)

Competencies:

Results orientation. The ideal candidate will thrive in a fast-paced, high-growth environment. He/She will have a strong drive to meet and exceed goals, even under adverse circumstances, and is willing to take ownership of problems and make decisions in order to move forward. The candidate will be adept at clearly defining objectives and priorities and establishing appropriate milestones through a strong understanding of the market and innovative approaches. He/She will assign accountability and incorporate disciplined processes to ensure success and nimbly handle 'derailments' with contingency plans and coordination.

Leadership. The successful candidate will have demonstrated the ability to lead and influence within a matrix organization globally and regionally. Additionally, this individual will have a track record of successfully leveraging diversity of thought to achieve the highest level of results. The ideal candidate will develop an inclusive culture enabling the team to function comfortably to achieve and exceed goals.

Strategic Orientation . The successful candidate will be able to articulate evolving priorities for the business, identify educational opportunities and adapt short-term plans. This includes the ability to strategically assess customer needs and build/execute specific, segmented strategies to educate and inform a diverse set of customers. The successful candidate will have passion for, and success in, developing medical affairs strategies that have measurable educational impact.

Collaboration and Influence. The qualified candidate must be able to influence without ownership, which he/she will do by demonstrating competence and confidence, being personally accessible and likable, being a good listener, use fact-based persuasion, passion, and persistence as appropriate to the audience and issue at stake. Gaining the support and involvement of key internal constituencies will be critical to success, as will influencing those important constituencies external to the company. The successful candidate must therefore have excellent skills at influencing outcomes, and shaping and catalyzing dialogue across and outside the organization. Credibility and integrity are critical attributes to effectively command the respect and trust of key individuals.

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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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