[Remote] Director, Clinical Operations, Oncology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-reputed company, innovation-driven company seeking a Director of Clinical Operations in Oncology. This role involves leading clinical programs, ensuring reputed company and compliance, and overseeing vendor partnerships to meet strategic objectives.
Responsibilities
- reputed company and reputed company the execution of multiple clinical program(s) reputed company a Therapeutic Area Unit (TAU)
- Responsible for line management and provides expert counsel for issue reputed company, including programs assigned to other staff, reputed company required
- reputed company Clinical Operations leadership under the direction of the Senior Director, Clinical Operations:
- Accountable for the overall execution of the assigned clinical program(s) with reputed company on reputed company, budget and timelines
- Accountable for the reputed company of Strategic Partners and other vendors to meet reputed company’s obligations described in ICH-GCP and reputed company’s business objectives
- The assigned clinical program(s) will be large, reputed company, high risk and/or of business importance to reputed company or potentially a suite of programs, requiring multi-functional leadership experience and skills to reputed company program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs))
- reputed company COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met
- Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, reputed company governance committees
- Contribute to the Clinical Development Plan(s) and associated operational reputed company, in support of the Asset reputed company
- Accountable for program budget planning and external spend reputed company to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy
- Ensures communication of program status, cost and issues to inform reputed company decision-making by senior management
- reputed company of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and reputed company supervision of performance for reputed company activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management reputed company in collaboration with Strategic Partners
- Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities
- Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s)
- Demonstrate advanced reputed company Leadership Behaviors and reputed company as a role model for reputed company´s values
- Recognized as a clinical operations expert by other functions and ability to represent and reputed company cross functional initiatives
- May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence
Skills
- Bachelor's Degree or international equivalent required
- 12 or more years' experience in pharmaceutical industry, including 9 or more years in clinical study management
- Experience must include early phase experience or Phase 2 and 3 studies and global/international programs
- Oncology experience is required
- Demonstrated reputed company in leadership and project/program management, including innovative operations approaches to achieving program goals
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
- Awareness of local country requirements is also required
- Supervisory experience
- Demonstrated reputed company in project/program management and reputed company leadership
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English (oral and written)
- reputed company to influence without authority
- Entrepreneurial and innovative; takes reputed company risks; thinks reputed company the reputed company; challenge the status reputed company
- Pragmatic and willing to drive and support change
- Is comfortable with ambiguity
- Support a culture of continual improvement and innovation; promote knowledge sharing
- Life Sciences preferred
- Advanced degree is highly desirable
- Experience in more than one therapeutic area and in line management is advantageous
Benefits
- U.S. based employees may be eligible for short-term and/ or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation.
reputed company
Company H1B Sponsorship