Sr. Director, Clinical Science (Oncology)

Introduction: Xencor•San Diego, CA

1d•Hybrid

About The Position

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 Sr. Director, Clinical Science (Oncology), to join our team. This is a hybrid position that can be based out of our San Diego or Pasadena, CA. locations. Responsible for facilitating successful and timely initiation and completion of the Company’s clinical development programs by executing and monitoring medical aspects of selected clinical trials.

Requirements

BS degree in life sciences; PhD, RN, PharmD or MS preferred
a minimum of 15 years of directly relevant pharmaceutical industry experience in clinical development
a minimum of 4 years’ experience of focus in assigned therapeutic area.
Experience as a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications also required
clinical research experience in area of focus
strong, hands-on working knowledge of drug development
experience working on cross functional clinical trial teams and liaising with study investigators.
Strong initiative, motivation, organization and hands on approach with outstanding attention-to-detail
Expertise 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.
Ability to work independently and prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishments
Excellent written and oral communication skills and interpersonal skills
Ability to adjust style/contents to suit the audience/purpose
Self-starter, highly motived, highly organized and hands on with outstanding attention-to-detail
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.

Nice To Haves

Prior experience with translational medicine/early phase clinical trials
monoclonal antibody biologics/immunotherapy
relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR is preferred.

Responsibilities

Creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND (in concert with Study Medical Directors)
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 scientific expertise to Clinical Operations by responding to questions and/or by clarifying issues arising during study conduct
Provides internal safety monitoring for clinical trials in collaboration with the Study Medical Director
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
Leads review of study data (e.g., tables, listings and figures and emerging bioanalytical data) and develops CSRs, clinical presentations and publications
Supports other members of Clinical Development and Regulatory Affairs departments as required
Participates as a standing member of multidiscipline Project Teams
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.