Director, Clinical Operations - San Diego, CA | Biospace
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Director, Clinical Operations

Xencor

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Location:
San Diego, CA
Posted Date:
3/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Director,

Job Description

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 three programs currently in clinical testing with two more expected to start clinical testing in 2017 and have an excellent opportunity for a Director Clinical Operations 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 ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations  with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, Merck, 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 Clinical Operations to


Job Duties include:

•   Provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality, and risk mitigation
•   Lead the development of contingency/risk management plans for projects and assist the Sr. Director of Clinical Operations in the preparation and execution of sound development strategies
•   Expected to lead the day-to-day activities of one or more assigned clinical trials; acting as the responsible Clinical Trial Manager
•   Oversee the activities of direct reports on the Clinical Operations team
•   Collaborate and ensure strong relationships with colleagues, outside consultants, and vendors to ensure successful completion of assigned clinical trials
•   Engage stakeholders in ongoing open dialogue that uncovers and mitigates challenges and leads to strengthening of the clinical team and its success
•   Accountable for quality data, meeting timelines and providing guidance to clinical study team as needed. Oversees the review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures
•   Oversees the review and the approval of the CRO/vendors, vendor on-boarding and management throughout the life-cycle of the study
•   Responsible for hiring, training, mentoring and managing the day-to-day activities of the clinical operations group, including Clinical Trial Managers, Clinical Research Associates and Clinical Trial Assistants
•   Serves as point of contact for day-to-day issues escalation and resolutions on assigned projects, and in support of assigned clinical operations staff
•   Reviews status reports and  timelines for milestone deliverables generated by CTM/CRA/CTA (eg. subject tracking reports, biological sample management reports, drug inventory etc.)
•   Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation
•   Actively contributes to Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs, WIs and department level training
•   Conducts ongoing performance management, performance reviews/appraisals and career development planning for all direct reports
•   Responsible for building a sense of esprit de corps within the clinical department
   

Requirements

•   BA/BS or equivalent degree in scientific discipline (required)
•   15+ years of clinical trials research management experience in a pharmaceutical/biotechnology company (preferred), CRO industry experience (considered)
•   Minimum 5 years experience in a line management/supervisory role
•   Demonstrates extensive technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing)
•   Excellent attention to detail and accuracy in work with proven ability to work independently, with a high level of integrity on multiple tasks
•   Strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
•   Excellent sense of urgency to deliver at/surpass study conduct targets
•   Proven experience working in an emerging biotechnology/pharmaceutical/CRO company leveraging outsourced work to CROs/Vendors
•   Ability to establish and maintain effective working relationships with coworkers, assigned staff, and senior management
•   Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
•   Experience with SmartSheet (preferred)
•   Experience with Veeva Vault eTMF system (preferred)
•   Expert knowledge of ICH GCP as relates to clinical trial management
•   Demonstrated financial acumen in planning and managing clinical program budgets
•   Experience at/or oversight of outside clinical research vendors (CROs, central laboratories, imaging vendors, IXRS, etc.)
•   Extensive experience and accomplishments in the pharmaceutical or related industry, e.g., with proven Global Phase 1-3 study experience and with filing INDs, CTAs and BLA/NDAs (highly preferred)
•   Experience in Oncology and/or Autoimmune therapeutic areas (highly preferred)


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