Executive Medical Director, Clinical Development

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 an Executive Medical Director, Clinical Development-Oncology, to join our team.

This is a hybrid position with a minimum of 2 days a week on-site. This position can be based out of our San Diego, CA or Pasadena, CA locations.

Summary:
The Executive Medical Director, Clinical Development (Oncology) will lead the execution of key bispecific antibody programs in solid tumors. Reporting to the SVP of Clinical Development & Medical Affairs, this individual will serve as a key clinical leader responsible for driving program strategy, ensuring scientific and medical rigor, and collaborating across functions to drive program success from early-stage development through late-phase / registrational trials.

Job Duties:
Strategic Leadership & Program Direction

• Provides strategic leadership and medical expertise for the clinical development of bispecific antibodies in oncology
• Drives program strategy for complex individual and combination programs, partnering with the Program Team Lead and Program Team Members to deliver comprehensive Development Plans
• Defines global clinical development strategies, anticipating regulatory pathways, competitive dynamics, and scientific inflection points

Cross-functional Partnership & Collaboration

• Partners with teams across Biostatistics, Regulatory Affairs, Clinical Operations, Safety, Translational Science, and other key functions to ensure cohesive and efficient program execution
• Drives integrated decision-making in a fast-paced environment by aligning stakeholders

Clinical Study Design & Execution

• Designs, plans, and oversees the execution of clinical studies, from early through late-stage development
• Works closely with Clinical Operations to provide medical expertise and execute the clinical trial with high quality and according to timelines
• Coordinates (and, as necessary, performs) ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
• Partners with Pharmacovigilance to provide internal safety monitoring for clinical trials
• Accountable for delivering clinical protocols and key clinical elements of other documents including investigator brochures, DSURs, clinical modules of the IND and other regulatory correspondence

External Scientific Engagement

• Develops and maintains relationships with therapeutic area key opinion leaders and clinical trial investigators
• Represents the company as a senior clinical leader in scientific, regulatory, and medical forums

Other

• Ensures compliance with regulatory standards and guidelines, including health authority requirements
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight, mentorship and direction to direct and indirect reports, as applicable
• Performs other duties as required.

Education/Experience/Skills:
Position requires a medical degree (MD, DO or equivalent ex-US medical degree), with board certification in hematology, oncology, or both and a minimum of 8 years directly relevant pharmaceutical industry experience in clinical development, of which at least 5 years must include an oncology focus, including immune-oncology space. Previous experience including 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 required. Prior people management experience is also required.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.

Position also requires:

• Strong initiative, organization and attention to detail
• Excellent written and oral communication skills and interpersonal skills
• Delivering concise, high-quality executive presentations to senior leaders, board-level audiences
• 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.
• 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
• Strong analytical, assessment and problem-solving skills
• Ability to read, analyze and interpret complex clinical data and information
• Expertise performing 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
• Strong knowledge and expertise performing relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR. Experience in monoclonal antibody biologics/immunotherapy clinical development and with translational medicine/early phase clinical trials is preferred

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Expected Base Salary Range: $357,500 - $410,000
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/.

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.

Salary : $357,500 - $410,000