Director/Associate Director, CMC Regulatory

Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego.  We have a very deep drug development pipeline including six programs currently in clinical testing with two more expected to start clinical testing by 1H2019 and have an excellent opportunity for a Director/Associate Director to join our team.  We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life.  In addition to generating a pipeline of novel drug candidates, with eleven in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations  with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.  

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 Director/Associate Director CMC Regulatory within CMC Operations to be responsible for working in a highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Affairs and Quality teams as well as contract manufacturing organizations, external experts, and strategic partners.  The position will serve to provide a strong Regulatory perspective in support of developing innovative CMC regulatory strategies for biological products in current and future clinical development. The position will also be responsible for hands on management of the collaborative preparation and submission of high quality CMC sections of INDs, IMPDs, CTAs, and BLA.

This position interacts with multiple levels of the organization.  Candidate must have the ability to approach issues from a strategic perspective and demonstrate strong leadership skills, business acumen, communication/presentation skills, and the ability to influence others.  This includes the ability to effectively drive both internal and external (virtual) teams, through active management of multiple client relationships supporting all Xencor programs.

Key Responsibilities:

• Provides strategic and tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements

• Serves as a regulatory CMC expert and can develop sound regulatory strategies

• Provides updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals

• Develops and maintains strong relationships within regulatory community

• Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project lifecycle, to project teams and appropriate management levels

• Provides US regulatory intelligence to project specific regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios

• Contributes to the creation and maintenance of Target Product Profiles

• Serves as the primary CMC regulatory representative on multiple concurrent projects

• Responsible to ensure all CMC RA deliverables associated with each project are completed within defined timelines and meet regulatory guidelines

• Works with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality

• Assists with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains outstanding

• Performs other related duties as assigned

Qualifications:

• Minimum of Bachelor’s degree in relevant Science or Engineering Discipline with 10 or more years of pharmaceutical or biopharmaceutical industry experience

• Broad understanding of global CMC regulations, processes and issues in drug development

• Experience as a regulatory contributor for global IND/IMPD/CTA/BLA filings in the US and Europe

• Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD)

• 8+ years in regulatory CMC in biopharmaceuticals preferred

• Working knowledge of chemistry/biotechnology, analytics, pharmaceutical technology or drug development process desirable

• Proven collaboration management, decision making skills and goal-orientation 

• Demonstrated ability to forge and maintain strong relationships with internal staff and external parties

• Strong leadership skills with ability to tactfully and effectively negotiate and influence

• Able to understand and interpret data/information and its practical application

• Ability to communicate and present ideas to all levels of staff and management

• Capable of supporting/managing several projects simultaneously and prioritizing individual and team efforts accordingly

• Be a team player and self-starter who is capable of growth and increased responsibility

• Detail oriented and good analytical problem-solving skills

• Strong computer skills including proficiency in MS office suite (Word, Excel, Power Point) and Adobe Acrobat

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. 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com   EOE