Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area (Monrovia, CA) with a strong focus on bispecific antibodies and Fc engineering. We have an expanding clinical pipeline of promising therapeutic candidates and an immediate requirement for a Head of Preclinical Development. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with twelve in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Alexion, Astellas, and Genentech.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We seek a VP of Preclinical Development to lead scientific and managerial oversight of safety/toxicology, pre-clinical development, primate studies (non-GLP and GLP), and bioanalytical activities to support IND filings and ultimately BLA filings. This role will report to the CSO and mentor and guide staff to optimize the correct balance of science, global health authority expectations, and discovery-stage program derisking. Determine and mitigate organizational gaps and development of internal capabilities and outsourcing strategies to meet or exceed global health authorities' requirements and portfolio needs. Identify labor sources as necessary, for scientific and regulatory needs and development of a vertically integrated organization.
Core Responsibilities include:
• Collaborative oversite of preclinical safety assessment/toxicology, from preclinical development and IND-enabling activities through Phase III registrational studies and subsequent transition to commercialization
• Leverage regulatory expertise and knowledge of regulatory requirements and regulations to strategically translate, plan and communicate requirements to ensure governmental approvals
• Development and implementation of company policies and procedures for Preclinical development
• Effective leadership and management of Safety Pharmacology and Bioanalytical groups ~ approximately 25 employees and growing
• 15+ years experience in the areas of Toxicology and Regulatory Interaction
• Direct experience with biologics drug development and toxicology/safety assessment at multiple stages of development (IND through BLA)
• Hands-on participation in primate study design and implementation
• Strong strategic and critical thinking, diplomacy, negotiation, and excellent oral and written communication skills
• Proven ability to lead, coach and motivate employees
• Experience with bispecific antibodies a plus
• Ph.D. degree with equivalent, relevant experience required
• 15+ years of industry experience in Regulatory Affairs and Toxicology for biologics products in product development and post licensure environments
• Knowledge of global regulations/guidances and thorough knowledge of biological (large molecule) drug development process
• Experience with international regulatory submissions preferred
• Strong, hands-on people leadership experience and ability to guide and develop a team
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume to email@example.com. For further information about Xencor, please visit our website at www.xencor.com
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