Kyowa Kirin, Inc.
Location
Princeton, NJ | United States
Job description
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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.
Summary ** This is a Hybrid role requiring two office visits per week OR eight office visits per month**
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 eight (8) 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
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. Proficiency in MS Office Suite (Word, Excel, PowerPoint and Outlook).
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.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller's data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].
Recruitment & Staffing AgenciesKyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Hybrid
Job tags
Salary
