Director, Clinical Operations- Clinical Trial Execution

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary:

Responsible for executing clinical strategies and ensuring clinical trials are conducted efficiently to agreed corporate timelines and following regional and global requirements.

Essential Functions:

* Responsible for supporting Clinical Operations with overall management of the department's clinical studies including project planning, clinical budgets, resource management and outsourcing management for assigned assets / therapeutic category unit.
* Acts as an integral resource for Clinical Operations members, taking on Clinical Trial Management roles and responsibilities where necessary, and ensures compliance with good clinical practices and regulatory guidelines.
* May lead the direct day-to-day management of one or more clinical studies, coordinating resources and ensuring operational milestones are met.
* Oversees clinical trials staff, including performance management, hiring and firing of direct reports, and participates in management of all aspects of the clinical operational plan.
* Manages the full scope of programs and studies and assists with implementation of clinical policies. Acts as a cross functional liaison to ensure program and study plan aligns with business development strategies.
* Build and lead a cross functional Clinical Operations team. Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges, and risks throughout the duration of the study.
* Ensures that cross-functional process efficiencies (related to Clinical Operations) are identified and maximized in accordance with project goals and that compliance is maintained.
* Act as the operational program leader for assigned clinical studies to ensure they are conducted in accordance with internal SOPs and ICH GCP requirements enabling real time inspection readiness.
* Planning, management, and execution of multi-region based clinical study(ies), including late phase development. Define and drive study timelines and milestones with Project Management. Evaluates, refines, and makes recommendations for various operational constructs for study execution.
* Collaboration with clinical science, data management, and clinical trial sub-team members based in other regions or companies (and other team members) to develop protocols that reflect good clinical practice, evolving landscape, regulatory and reimbursement requirements and meet the strategic program objectives.
* Lead problem solving and resolution efforts to include management of risk, contingencies, and issues. Develop proactive contingency plans to mitigate clinical risk.
* Address enrolment and retention issues, identify and implement actions to keep study on track.
* Develop and manage clinical development plans and lead end-to-end strategy development including engagement with external stakeholders and partners.
* Contribute to the development of the Target Product Profile and Life Cycle Management activities.
* Leads the feasibility and CRO selection strategy and develops tactics to successfully work with CRO study personnel, investigators and other roles at medical centers in order to develop, execute and deliver clinical studies/programs supporting drug development with focus on speed, cost and quality.
* Create a true partnership with CRO and Key Vendors. Able to influence CRO study personnel to effect change when necessary. Escalates poor CRO performance in a timely fashion.
* Operationally contribute by reviewing and writing sections of regulatory submission documents, responses and communications with regulatory bodies including briefing documents, scientific advice, NDA/BLA/MAA. Participation in health authority meetings as indicated.
* Understand HEOR strategy and implementation in development plans.
* Develop and maintain a strong network of key opinion leaders to facilitate successful development needs through drug approval.
* Provide regular study status updates including critical issues to Development Management and Senior Management as needed.
* Support the Clinical Study Teams with stakeholder management and issue escalation.

Requirements:

Education
Bachelor's degree, RN, BSN, Health, Science or closely related discipline. Advanced degree preferred.

Experience
Minimum 12 years of experience in study management at a sponsor/biotechnology/pharmaceutical company. Minimum 5 years demonstrated managerial, organizational, and leadership skills in a dynamic environment running multiple clinical trials. Prior experience conducting large, global Phase II and III studies and understands the operational pathways of working outside the U.S.

Technical Skills
Proficient in MS Office Suite.

Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations. Proven track record of managing pivotal studies and strong submission (NDA/MAA etc) experience. Highly effective influencing skills and the ability to operate across multiple geographies. Strong track record of delivering results through effective team and peer leadership. Strong Proficiency in MS Office Suite (Word, Excel, PowerPoint and Outlook).

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

Requires up to 25% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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