Veterans Preferred - Director, Medical Safety Science - Medical Evaluation:
Kite Pharma

1573228800
Kite Pharma
Santa Monica California
Pharmaceutical
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Description


Military Veterans are Encouraged to Apply.

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

We are seeking a highly motivated individual to join us as a Director, Medical Safety Science - Medical Evaluation with strong communication and teamwork skills.

Specific Responsibilities

  • Reviews adverse reports received for marketed and investigational products, adhering to standard operating procedures for medical assessment of individual case safety reports providing safety assessment and pharmacovigilance comment
  • Collaborates with Pharmacovigilance Science -in the identification and assessment of safety signals and trends; presentation of medical safety review to product safety committees and senior management, and supports management of any potential safety issues; provides medical review of aggregate reports such as periodic safety update report (PSURs) and other periodic safety reports
  • Contributes to preparation and review of safety documents in response to regulatory inquiries
  • Participates in audits, data analysis, and other ad hoc activities
  • Participates in both internal and external educational initiatives
  • Contributes to, and may manage, a critical component of a functional or cross-functional project
  • May lead and initiate functional area projects
  • Participates in process improvement initiatives by identifying areas for improvement and solutions
  • May serve as medical monitor for post-authorization safety studies
  • May serve on interdepartmental cross-functional projects or clinical sub-teams
  • Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities
  • Establishes recognition as an expert on medical safety assessment of individual cases


Essential Duties and Job Functions
  • Provides medical safety review and/or sign off for wide variety of safety documents, both within Safety and Pharmacovigilance and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products
  • Performs continuous risk/benefit evaluation throughout the lifecycle of assigned products


Basic Qualifications
  • MD/DO degree
  • Either (1) minimum of 2 years' experience in a pharmacovigilance or an applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements OR (2) an exceptional track record of excellence in an area including clinical research, health administration, health policy, epidemiology, or academic or subspecialty medicine


Preferred Qualifications
  • Completion of an accredited residency program. Board certification preferred
  • Demonstrates deep understanding of pharmacovigilance practices including MedDRA coding and worldwide safety regulations and guidelines
  • Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
  • Acknowledged by cross-functional teams as safety and pharmacovigilance product-specific expert
  • Proven ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
  • Shows confidence and expertise in handling complex clinical and post - marketing medical safety cases, and providing medical input in risk management activities
  • Demonstrates confidence in the presentation of safety reviews to safety committees and senior management
  • Demonstrates the ability to handle increasing and/or changing responsibilities (e.g. team growth, integration efforts across other departments or the organization)


Colorado Job Applicants: The salary range for this position is:
$191,760.00 - $287,640.00
Kite considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit

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 . Sign up to on Twitter at .

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.