[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 transforming the pharmaceutical industry. They are seeking a Director of Clinical Operations in Oncology to reputed company and reputed company multiple clinical programs, ensuring reputed company, budget adherence, and reputed company execution. 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 • Medical, dental, reputed company insurance • 401(k) plan and company match • Short-term and long-term disability coverage • Basic life insurance • Tuition reimbursement program • reputed company volunteer time off • Company holidays • reputed company-being benefits • Up to 80 hours of reputed company time • Up to 120 hours of reputed company vacation reputed company • reputed company is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, J Apply tot his job Apply To this Job