Director, Patient Safety

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 18, 2019
Ref
R0009970
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
We are seeking a highly motivated individual to join us as a Director, Patient Safety withstrong communication, and teamwork skills.

Responsibilities (include but are not limited to):

• Medical safety expert for product candidates including subject matter expertise in relevant underlying diseases and the science of immune effector cell therapy.

• Signal detection, evaluation and risk communication, assessment

• Review and approve aggregate safety reports,

• Being strategic (e.g. protocol development, RTQ response, submissions, labelling)

• Oversight of clinical trial safety including safety monitoring plan, investigator's brochure, protocol informed consent forms, and data analysis and clinical study reports

• Respond to queries from regulatory agencies and other internal functions

• Provide review of clinical protocols and study reports to ensure alignment with Clinical development plans and safety being adequately addressed.

• Contribute to regulatory authority submissions (e.g. NDAs, INDs, BLAs) by reviewing safety data and preparing relevant sections of the submission

• Inspection preparedness

• Training others, both in safety and external

Requirements:

• MD or equivalent degree

• 5 years of industry experience in safety and pharmacovigilance; Oncology experience preferred

• Global experience in clinical trial as well as post-marketing setting

• Global experience in regulatory filings

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Good knowledge of US and EU pharmacovigilance regulatory requirements

• Ability to function in a matrix organization

• Flexible and comfortable decision making in a fast-paced environment

#LI-JK2

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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