Job Summary: WuXi Clinical has created an Oncology Center of Excellence in order to attract a growing number of Oncology Clinical Trials and grow our presence and expertise in this therapeutic area.
The Senior Director of MD, Oncologist will provide leadership, strategic direction and medical expertise in Oncology to this center of excellence and to the organization and its customers. This individual will advise in all areas of the operation by being a resource in oncology with an emphasis on the operations, safety, and business development teams and will contribute to the overall oncology strategy for the company to facilitate organizational growth, delivery of services, and customer satisfaction.
Essential Job Functions:
- Provide leadership and Strategic Direction to the Oncology Center of Excellence while driving the growth of the Oncology therapeutic area business and helping identify, attract and retain top talent in this therapeutic area.
- Provide clinical direction and expertise in the area of oncology for the development and delivery of the clinical trial services and processes, including knowledge of emerging and innovative techniques
- Participate in the review and provide specialty expertise in all oncology requests for proposals (RFPs) coming to WuXi Clinical from different sources. This includes:
- Conduct a review of the clinical trial protocol or the protocol synopsis
- Create a Medical Considerations Document containing a brief summary of the current state of knowledge of the disease being studied and standard of care therapies; a general review of the clinical trial protocol; and recommendations regarding r study design, feasibility and enrollment rates, participating countries and site selection and any other suggestions for changes to the study protocol
- Interact with WuXi Clinicals business development group and with the sponsor of the study during the process of bidding for the business as needed
- Review of the draft proposals to guarantee a good flow and quality of the information provided in the proposal
- Participate in person in all bid defenses associate with oncology projects
- Provide education to WuXi Clinicals resources on clinical trials protocols or other oncologic topics related with oncology considered of relevance for the company.
- Interact with potential customers, opinion-leaders, academicians, investigators and other relevant people in the world of oncology with the objective of promoting WuXi Clinicals oncology capabilities and attracting new business to the company. This includes:
- Attendance and participate in relevant specialty meetings
- Visiting potential customers, key centers of excellence in oncology, and key opinion leaders in oncology to promote and disclose WuXi Clinicals firm commitment to become a leader in oncology clinical development
- Interact with national and international professional societies, oncology research groups, patient advocacy groups, etc. to divulge and promote the activities of WuXi Clinical in the field of oncology
- Review data listings of safety data and other clinical research data collected and follow up as appropriate with the project team
- Acts as escalation point for projects assigned to as Project Advisor. Works with internal and external teams to identify development strategies for protocols and programs.
- Participate and contribute to the WuXi Clinicals Medical Group with support, advice, and input related to the overall growth and improvement activities of this function.
Experience / Education:
- Medical degree and license required
- Specialty in Internal Medicine and subspecialty in Hematology-Oncology or Medical Oncology
- Board certified in hematology and oncology
- Additional education and certifications preferred
- At least eight (8) years or more of medical practice and clinical trial experience preferred
- Extensive global clinical trial experience preferred
Knowledge / Skills / Abilities:
- Extensive knowledge in the field of oncology required; and strong global clinical research trial experience preferred
- Early phase/FIH/proof of concept through pivotal/registration trial study design/medical monitor and/or oversight
- Experience in biomarker identification/assay development for immunotherapeutic agents
- Solid/liquid tumor clinical and clinical investigation experience including recent experience in immune-oncology and cell therapies as well as combo radiation therapy where relevant
- Clinical and research experience including stem cell transplants, GVHD graft-versus host disease
- Effectively communicates, both verbally and in writing, in clear, concise, professional manner with employees, senior management, external consultants and senior level customer contacts
- Must show ability to lead and effectively provide training, mentoring, and feedback to team members
- Good problem solving skills involving considerations of time, finance, quality, and customer relations
- Skilled at presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities
- Solid knowledge of computers and Microsoft Office Suite of products; knowledge and experience with tools specific to clinical trial and data management preferred (e.g. EDC/Paper systems, CTMS, IWRS, eTMF, etc.)
- Knowledge of FDA guidelines, ICH, GCP, NDA, IND, and other applicable regulations
- Travel is required approximately 25%, Domestic/International, Daily / Overnight
- Must have valid drivers license and the ability to rent a car
- Must be able to travel
- Must be able to work in an office or medical site
- Ability to stand or sit for most of the work day
- Must be able to perform some activities with repetitive motion, such as keyboarding
- Must be able to travel for long distances 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
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.