Overview

WuXi Clinical, a full service CRO, is hiring a Director Clinical Operations / Oncology.

This position will oversee all current oncology projects in the United States within the Austin, Texas based Clinical Operations department. The Director of Oncology will well versed and connected with all US oncology clinical sites, Principal Investigators and have a robust and rich experience in managing US / global Phase I-III clinical trials.

The Wuxi Clinical Operations Support Teams are currently made up of individuals involved in diverse disciplines including, Clinical Trial Managers and associates, data management and programing, and contracts management. The Oncology Group is supported by Regulatory, IT, Feasibility, HR, Finance, BD, Proposals and Contracts groups.

This position will also laisse and work closely with the Global Head of Oncology for WuXi Clinical in China. This position will be a member to the US Executive Management Team (EMT) and report into the US Executive Director, Clinical Operations with dotted line to President of WuXi Clinical Development Inc. / Site Head, WuXi Clinical, Austin.

This is an office or remote based position and requires approximately 25% travel.

Responsibilities

Essential Job Functions:

• Responsible for developing and maintaining a world-class US Oncology Group team through leadership and collaboration, as well as delegation of clinical trial execution to Clinical Trial Directors and Project Managers.
• Leads the US oncology clinical operations teams with responsibility for line management, strategic planning and alignment with broader organizational goals.
• Leads activities provided to the Oncology Group by the WuXi Clinical Operations teams.
• Sets overall direction, strategy and performance standards for US Oncology Group Operations staff to ensure that project objectives are achieved with highest quality, on time and within budgets.
• Assists with development and implementation of training plans, annual performance reviews and goals assessments and metrics by which to measure US Oncology Group clinical staff performance.
• Participates in and has accountability for overall US Oncology Group Operations strategy and performance against key trial metrics.
• Maintains a quality-focused US Oncology Group clinical infrastructure by developing and implementing and monitoring SOPs that are consistent with the resourcing strategy; ensures operational processes, systems and standards are consistent with GxP and are adopted, implemented and documented consistently across trials.
• Creates a resourcing strategy to support needs for all US Oncology Group clinical programs and activities.
• Leads and participates in project proposal development and Bid Defense Meetings for all US oncology studies
• Accountable for strategy, clinical trial execution, timelines, resource planning, budget forecasting and management.
• Serves as senior project interface with clients in role of project advisor.
• Leading cross-functional teams to provide high quality and timely execution of deliverables and overall trial service to the customer.
• Develops and maintain strong, collaborative relationships with key stakeholders inside and outside the organization.
• Ensures maintenance of corporate systems by collection of data to be included in the metrics database, sponsor database, investigator database, and protocols database.
• Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested.
• Assists with development of clinical protocols and SOP's.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Clinical Policies and Standard Operating Procedures
• Other duties as assigned.

Qualifications

Experience / Education:

• Bachelor's Degree required; MD or PhD preferred.
• Minimum of 8 years clinical research experience in CRO, pharma, biotech / device company with 5 years of Oncology, 6 years of directly related project management experience, and 4 years of supervisory experience of clinical and data project professional level individuals required.
• Solid experience in hematology indications preferred.
• Understanding of Oncology therapies and practice as it relates to clinical trial design.
• Experience in leading clinical and data project teams from study startup through clinical / statistical reports.
• Must demonstrate advanced knowledge of clinical, regulatory, and data aspects of trials including, but not limited to FDA review processes, IND and NDA processes, GCP's, field monitoring, data management, biostatistics, and medical writing.
• Must have advanced knowledge of FDA, ICH, and GCP guidelines.

Knowledge / Skills / Abilities:

• Superior problem-solving skills involving considerations of time, financial, quality, and customer relations.
• Ability to apply decisions from previous discussion to new situations independently.
• Requires minimal supervision on operational decisions that can have substantial impact on company, infrastructure, or policies.
• Excellent verbal and writing skills to communicate with team, sites, and clients and be an active listener.
• Ability to effectively communicate on issues and to autonomously implement resolutions to team members.
• Demonstrated excellent interpersonal communication skills and exhibit ability to lead team using appropriate motivational skills, conflict management, and integrity.
• Must exhibit positive, professional demeanor in all communications and must be able to introduce differing communication strategies to solve issues at the team and sponsor level.
• Must have excellent organizational and negotiation skills.
• Must have good working knowledge of physician care in hospitals, clinics, or other healthcare settings.
• Excellent project management skills including client management, fiscal management, and quality management; strong time management skills; and ability to thrive in stressful environment with multiple priorities.
• Must have high level of attention-to-detail and must have ability to deal professionally with team members, investigational sites, and clients.
• Must have strong management skills including ability to hire, coach/counsel, and terminate employees. Ability to create staff career plans and monitor progress.
• Must have ability to analyze resource usage with available tools.
• Must have solid knowledge of computers and Microsoft Office Suite of products.

Physical Requirements:

• Must be able to work in an office environment, which has minimal noise conditions.
• Ability to stand or sit for most of the workday.
• Must be able to perform some activities with repetitive motion, such as keyboarding
• Must be able to travel in various methods of transportation (i.e., car, airplane, shuttle bus, etc.)
• Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop.
• If working remotely must have access to high-speed internet service and have knowledge and ability to resolve IT and computer related challenges through remote communications channels.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.