Senior Director of Clinical Operations
Job Description

1) Develop and implement clinical development plans for new or ongoing oncology studies
2) Identify and manage contract resources, including CRO and other third party vendors, and oversee the management of clinical operations contracts
3) Partner with Supervisor to develop Staff, Structure Department, ensure appropriate personnel and resource allocation across programs and trials
4) Create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
5) Oversee activity related to the Clinical Operations Department infrastructure (e.g. SOPs, CTMS, budget and planning)
6) Manage global monitoring of compliance and timelines for all clinical trials
7) Act as a liaison across departments and represent clinical operations at an executive management level
8) Lead multiple Study Execution Teams (SET) across more than one program as needed
9) Oversee functional deliverable to support program objectives as defined in the clinical development plan
10) Identify risk, develop risk mitigation plans and escalate risks and risk mitigation strategies to the Clinical Operations function head, and PDT as appropriate
11) Participate on Product Development Teams (PDT) and any sub- teams or ad hoc committees as needed or requested
12) Manage high level oversight of programs and trials which includes monitoring data, i.e., flow from the sites (CRF completion) to data entry (CRF's entered in database) to data listings
13) Manage progress of trials to plan by managing study scope, timeline and resources within parameters defined in the development and operating plans
14) Be accountable for strategic planning for site selection, contract negotiations and patient recruitment programs
15) Be accountable for writing clinical operation sections of regulatory documents including protocols, investigator brochures, IND annual reports and others as needed or requested
16) Be accountable for ensuring compliance with company SOPs and guidelines, FDA regulations and current ICH GCP guidelines
17) Partner with senior management to develop and to achieve corporate and department goals and work with clinical operations staff to achieve the established corporate and department goals within the expected time frames
18) Partner with Vice President of Clinical Operations and Senior Clinical Operations staff to address departmental initiatives and issues and also to ensure operational consistency across multiple programs
19) Engage in strategic planning activities and translate strategic decisions into operational plans both within the department and cross-functionally
20) Accurately and pro-actively project resource needs to ensure timely hiring of Clinical Operations Staff
21) Embody the company core values and serve a leader for the Clinical Operations Department in demonstrating these values through everyday actions and behaviors
22) Manage a significant number of Clinical Operations staff including more senior level personnel (e.g. Managers, Associate Directors and Directors) for leading cross-functional study teams in the implementation and execution of clinical studies
23) Partner with Clinical Operation team members to identify and develop efficient and innovative systems for enhancing department efficiency
24) Manage study personnel responsible for the implementation and execution of clinical trials
25) Mentor and develop employees to expand employee performance levels and ensure retention of high performing company employees
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Job Requirements

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the bio-pharmaceutical industry is strongly preferred
4) Preference will be given to people have recent experience in clinical operations, oncology

Company Overview

Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.


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