Associate Director, Medical Information
Medical Affairs | Santa Monica, CA | Full Time
Kite, a Gilead company, recently launched its first commercial product, YESCARTATM (axicabtagene ciloleucel), and is also actively engaged in the development of other innovative cancer immunotherapies with a goal of providing long-term durable responses to eliminate the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) genetically modified cell therapies designed to empower the immune system's ability to recognize and attack tumor cells which express a target antigen. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com.
We are seeking a highly motivated individual to join us as a Senior Manager or Associate Director of Medical Information. This position will be responsible for process improvement initiatives including the development and ongoing management of best practices, work instructions, and standard operating procedures to optimize Medical Information services around YESCARTA and Kite’s CAR- and TCR-based investigational therapies. This person will support developing strategies aimed at global alliance across multiple geographies and reporting systems. The SM or AD will work with Drug Safety and Quality Assurance to ensure reported adverse events and product complaints are captured and triaged in a timely and compliant manner. This person will author standard response letters and contribute to the development of evidence-based submission packages in alignment with compendia strategy. In addition, this individual may support the review and approval of promotional and non-promotional materials along with the development of AMCP formulary dossiers. This role requires exceptional organizational and project management skills along with high proficiency in technical writing and verbal communication.
Responsibilities (include but are not limited to):
- Lead process improvement initiatives and development strategies to optimize medical information policies and procedures towards global alignment
- Partner with Pharmacovigilance and Quality Departments to ensure AEs and PCs are captured and triaged in a timely and compliant manner
- Utilize expertise and functional knowledge of the literature to collaboratively and effectively work within cross-functional teams to provide scientific input into the development strategy of YESCARTA and Kite’s investigational therapies
- Author standard response letters and contribute to evidence-based submission packages as a subject matter expert
- Directly and independently handle unsolicited medical inquiries escalated to Kite Medical Information
- Represent Kite at major scientific meetings and conferences
- Advanced degree in the life sciences (PharmD, PhD, MD)
- 5+/8+ years of experience in the industry
- Prior experience in Medical Information is highly preferred
- Prior corporate experience in hematology/oncology therapeutic area is highly preferred
- Knowledgeable of applicable regulations regarding dissemination of medical information, drug promotion, and adverse event/product complaint reporting
- Strong technical reading, writing and communication skills
- Highly motivated to function proactively, operate with a sense of urgency, and bring tasks to completion
- Ability to work independently with minimal supervision and collaboratively as a key contributor to multi-departmental teams
- Demonstrated ability to manage a large number of complex projects simultaneously
Kite is an equal opportunity employer based in beautiful Santa Monica, CA. Kite offers the opportunity to be part of a successful, fast growing company in a cross-functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com.
No phone calls please and no agencies or recruiters.