Director, Clinical Trial Management Details

Director, Clinical Trial Management

Xencor - San Diego, CA

Employment Type : Full-Time

Introduction:

Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area—near Pasadena—and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics, antibodies and cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for an Director, Clinical Trial Management to join our team.

The Clinical Team is based in San Diego. We are open to hiring someone in the San Diego or Southern California region open to being onsite possibly up to 2 days/week.

Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.

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.

Summary:

Responsible for directing tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities.

Primary Responsibilities:

• Guides study team in vendor selection and provides management oversight throughout the life of all assigned clinical projects, proposes vendors for approval.
• Ensures operational feasibility of clinical development plans and scenarios, including time, budget, and resource requirements
• Analyzes protocol to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements, and IP labeling requirements
• Works with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames
• Manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines, edit check specifications, database build, query resolution and database cleaning), relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines
• Serves as Clinical Operations leader and main point of contact with counterparts of outside vendors, CRO and/or trial sites
• Conducts daily reviews to identify potential issues or problems and communicates/escalates to CTL/Project Team
• Develops, maintains and promotes effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel
• Participates in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs and department level training and cross project initiatives
• Prepares and maintains Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents
• Informs the CTL/Project Team of outstanding documents
• Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
• Leads 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
• Performs in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues
• Develops and maintains tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
• Supports financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
• Track’s patient and recruitment status using applicable spreadsheets and web portal tools
• Assists in the critical development and review of key study documents (e.g., Protocol, ICF, study plans, eCRF etc.)
• Assists with the development of department organizational structure.
• 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 Bachelor’s degree in a field of science such as biology or chemistry, a degree in nursing or pharmacy is preferred, and at least 12 years of related experience, including 8 years in clinical trial management. At least 5 years of people management experience also required. Experience working in a small company in the biotech or pharma industry preferred.

The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.

Position also requires:

• Expert knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Excellent time management and organizational skills
• Excellent attention to detail and accuracy in work, completing critical tasks on time with quality
• Ability to establish and maintain effective working relationships with coworkers, managers and vendors
• Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project
• Ability to think critically and creatively and determine appropriate actions to resolve complex problems
• 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 of the office 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 Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

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, including any boosters recommended by the CDC. New employees will be required to provide proof of their fully COVID-19 vaccinated 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.