Associate Director, 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:

The Associate Director, Clinical Operations is responsible for supporting the overall management of the assigned-clinical studies including project planning, clinical budgets, resource management and outsourcing management for assigned therapeutic area (TA). This position is an integral resource within Clinical Operations supporting senior management, taking on Clinical Trial Management roles and responsibilities and ensures compliance with good clinical practices and regulatory guidelines.

Essential Functions:

•    Acts as the primary clinical operational oversight for the assigned project/study, lead 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 assigned clinical study(ies), including late phase development. Define and drive study timelines and milestones with Project Management.
•    In collaboration with program level management, evaluates, refines, and makes recommendations for various clinical operational aspects for study execution.  
•    May collaborate with Clinical Science and other cross functional clinical trial 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 on assigned studies. Develop proactive contingency plans to mitigate clinical risk.  Work with CRO and other vendors to ensure alignment on issues and mitigations.  
•    Address enrolment and retention issues, identify and implement actions to keep study on track in collaboration with program level management.
•    Contribute to 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, deliver clinical studies supporting drug development with focus on speed, cost and quality.
•    Create a 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 to program level management.
•    Contribute to the development of applicable 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.
•    Maintain a good communication with key opinion leaders to facilitate successful development needs from study planning to completion.
•    Provide regular study status updates including critical issues to Program level management as needed.
•    Support the Develop Team and Clinical Study Teams with stakeholder management and issue escalation
•    Contributes to the design of operational excellence activities including study and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.

Requirements:

Education
Bachelor’s degree, RN, BSN, Health, Science or closely related discipline. Advanced degree highly desired.

Experience
Minimum ten (10) years of experience in study management at a sponsor/biotechnology/pharmaceutical company. 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.

Demonstrated 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. Highly effective influencing skills and the ability to operate across multiple geographies. Proficiency in MS Office Suite (Word, Excel, PowerPoint and Outlook).

Non-Technical Skills
Demonstrated ability to organize