Associate Director, Clinical Science (Autoimmune)

Xencor; Pasadena, Northern (CA, KY); Hybrid; USD 171,000 - 209,000; Full time

Benefits offered by this job

401k match

Healthcare coverage

ESPP

Annual bonus

Equity grant

Job summary

Xencor is seeking an Associate Director, Clinical Science (Autoimmune) to drive successful initiation and execution of global autoimmune trials, with emphasis on IBD and related inflammatory diseases. The role requires extensive clinical development experience, leadership in trial design, data interpretation and regulatory collaboration.

The candidate will lead cross-functional teams, review emerging data, and contribute to CSRs and publications.

Qualifications

• BS in life sciences; advanced degree preferred.
• Minimum 10 years of pharmaceutical industry experience in clinical development with 2 years in autoimmune areas.
• Experience as a clinical scientist with data review, safety monitoring, protocol development, analyses and publications.
• Experience with translational medicine/early-phase trials and monoclonal antibody immunotherapy is preferred.

Responsibilities

• Creates clinical trial documents (protocols, investigator brochures, DSURs, IND modules).
• Collaborates with Clinical Operations to execute trials on time and with high quality.
• Reviews clinical data and supports data cleaning and interpretation.
• Provides medical input to data management plans, safety monitoring plans and analysis plans.
• Maintains relationships with trial investigators and key opinion leaders.
• Leads review of study data and develops CSRs, presentations and publications.

Skills

Initiative

Organization

Attention to detail

Independent work

Communication skills

Education

Bachelor's degree in life sciences

PhD, RN, PharmD or MS preferred

Tools

MS Office Suite

Visio

GraphPad Prism

Spotfire

Medidata RAVE

Inform

Job description

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 n Associate Director, Clinical Science (Autoimmune), to join our team.

This is a hybrid or remote position. Hybrid would be based out of our San Diego or Pasadena, CA locations.

Summary:

Responsible for facilitating successful and timely initiation and completion of the Company’s clinical development programs in Inflammatory Bowel Disease (IBD) and other autoimmune programs by executing and monitoring medical aspects of selected global clinical trials. This role will support the design, execution, monitoring, and interpretation of randomized, placebo-controlled clinical trials in IBD as well as studies in healthy volunteers.

Primary 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
• Performs other duties as required.

Education/Experience/Skills:

Position requires a BS degree in life sciences; PhD, RN, PharmD or MS preferred and a minimum of 10 years of directly relevant pharmaceutical industry experience in clinical development and a minimum of 2 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, as well as clinical research experience in IBD on randomized, placebo-controlled trials.Prior experience with translational medicine/early phase clinical trials, monoclonal antibody biologics/immunotherapy, and relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR is preferred.

Position also requires:

• 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

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: $170,500 - $208,500

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 [e-mail].

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.