Medical Director, Clinical Development-Rheumatology

Medical Director, Clinical Development-Rheumatology 

Introduction:

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Medical Director, Clinical Development with a focus on rheumatology to join our team.

This position can be fully remote

Summary:

Responsible for providing strategic and tactical medical leadership and oversight of clinical studies, including engagement with partner investigators, while ensuring compliance of all relevant regulatory guidelines. 

Job Duties:

• Creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND
• Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
• Performs ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
• Provides medical expertise to Clinical Operations by responding to questions or clarifying issues arising during studies
• Provides internal safety monitoring for clinical trials 
• Provides medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plan
• Develops and maintains relationships with clinical trial investigators and therapeutic area key opinion leaders as needed
• Leads review of study data (e.g., Tables, Listings and Figures and emerging bioanalytical data) and development of CSRs, clinical presentations and publications
• Supports other members of Clinical Development and Regulatory Affairs departments as needed
• Participates as a standing member of multi-discipline Project Teams
• Interacts with external investigators and collaborators
• Ensures that the above tasks are performed in the most efficient manner possible, commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
• Ensures that all activities/reviews are compliant with the latest safety standards and regulations
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures.  The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Performs other duties as required.

Education/Experience/Skills:

Position requires a medical degree (MD, DO or equivalent ex-US medical degree) and at least 12 years of related work experience, to include at least 2 years of directly related pharmaceutical industry experience in clinical development.  Experience in analysis and interpretation of emerging clinical data, including use of software packages to analyze data (e.g., pivot tables) and EDC: MS Office Suite, Visio, GraphPad Prism, Spotfire, Medidata RAVE, Inform etc. also required.  Other previous experience to include data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications, experience working on cross functional clinical trial teams and liaising with study investigators. Prior experience with relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR, with monoclonal antibody biologics/immunotherapy clinical development and in translational medicine/early phase clinical trials is preferred.

Position also requires:

• Strong initiative, organization and attention to-detail skills
• Ability to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment
• Excellent written and oral communication skills and interpersonal skills
• Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
• Excellent time management and organizational skills
• Strong analytical, assessment and problem-solving skills
• Ability to read, analyze and interpret complex clinical data and information
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands when working in the office environment are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

• Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
• Ability to work and sustain attention with distractions and/or interruptions.
• Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
• Ability to maintain regular attendance and be punctual.
• Ability to understand, remember and follow verbal and written instructions.

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Additional travel (domestic and/or international) for scientific conferences and/or other meetings with collaborators is possible. Otherwise, work for this position is generally performed at Xencor’s worksite and requires full-time commitment. 

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

Expected Base Salary Range:  $264,500 - $304,200

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.