[Janssen] GCO ED&CP Site Strategy Lead

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. - Sector: Janssen - Position: Global Clinical Operations ED&CP Site Strategy Lead - Work-Type: Regular The Early Develop and Clinical Pharmacology (ED&CP) Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area/countries. This role will support program and study level country/site recommendations during feasibility and ensure effective country/site allocations. Evaluate Janssen ED&CP portfolio needs with local GCO resources, PDO, TA, FCOE, and other stakeholders to develop and implement strategies / techniques to identify, assess and deploy new / existing sites with appropriate capabilities, infrastructure, staffing and capacity. Directly support feasibility and site selection processes and strategy with consideration of program / study needs as well as country / regional considerations. Create and execute strategies for strong site relationships to leverage in study planning and execution. The ED&CP SSL will ensure there is strategic approach to connecting with key stakeholders and developing GCO recommendations for study / site feasibility as well as allocations endorsed by the ED&CP Regional Heads (regionally and globally) in alignment with relevant SOPs, TA strategies, and GCO level strategic site development approaches / objectives. This includes approaches to identify and qualify sites which will meet requirements for study delivery. The ED&CP SSL will directly collaborate with SRPs, SRS/CSs, GPLs, GTLs, GFLs and local country operations to identify appropriate strategy and tactics for the region assigned. He/she will collaborate with KOLs and site operation leaders within the regions to facilitate development of strong site relationships supporting complex study execution and novel drug delivery. The position requires direct experience with clinical trial strategic planning / execution, including ED&CP clinical operations expertise, a deep understanding of sites/ study set up, plus understanding of regional regulations and health care systems. [Responsibilities] [Requirements] Define and lead implementation of GCO ED&CP site development and engagement strategy in assigned area, aligned with country capabilities and the Janssen ED&CP R&D strategies. This will require proactive planning and effective site strategy development actions. Ensure site development, engagement and study placement strategies are endorsed by the ED&CP Regional Heads in alignment with Regional strategies, FCOE and PDO. Ensure early alignment with key stakeholders including SRPs, SRS/CSs, GPLs, GTLs, IPPI team, Feasibility Centre of Excellence with country outreach and site feasibility assessment. Define and deploy techniques, communications, and approaches to develop evolving list of core sites (may be unique to each TA) to meet current and future needs of portfolio (TA and study type). Supports decision making for allocation and utilization of core sites with consideration of program / portfolio considerations and ED&CP Footprint, resourcing and allocation strategy. Acts as a Subject Matter Expert with regional expertise in Early Development for site selection, start-up and study execution. Support study operational ED&CP specific requirements in collaboration with ED&CP TMs (local Operation Liaisons), KOLs and site leadership in alignment with the TA and PDO leadership. Partner to assess protocol and institutional capabilities to ensure operational complexities are addressed. Ensure future list of sites with ED proficiencies and capable of meeting expedited timelines are available for program and study level feasibilities. The ED&CP SSL will consolidate information from the countries and sites in collaboration with Local Country Operations (i.e. ED&CP TMs, local Operation Liaisons, FMs, FCOE) in development of the study execution strategy and milestone targets including any broader risks for consideration in mitigation plans. Support local GCO teams to leverage site specific knowledge and relationships in planning / conduct of trials. Support local GCO teams to provide regional and site information for discussion with TA and PDO in portfolio review and TA consensus meetings. Share updated information from portfolio review meetings with the ED&CP FMs and Regional Heads in preparation for upcoming trial consensus meetings. Provide input and supports development of program / study level commitments for study deliverables. Ensures appropriate and timely escalation of issues related to study placement to GCO ED&CP Regional Head. Strongly demonstrates Leadership Behaviors in alignment with Leadership Imperatives Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization) in the region including evaluation of performance metrics. Build strong relationships with ED&CP Functional Managers, , ED&CP Local Operating teams, IPPI team, Portfolio Delivery Operations (PDO and the ED Unit), FCOE and other internal/external business partners as required. [Qualifications] Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site. ED&CP previous clinical trial experience is preferred. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to build strong internal and external partnerships Effective leadership skills. Ability to develop and implement strategies and to foster team productivity and cohesiveness. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Flexible mindset and ability to work at a fast paced in a fast-changing environment in different therapeutic areas. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Solid decision-making skills. Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Ability to synthesize and evaluate data generated from various reports and sources. Operates under limited supervision. Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. [For more Johnson & Johnson] - J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/ - J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/ - J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info www.careers.jnj.com At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Qualifications - Primary Location South Korea-Seoul-Yongsan-gu- Other Locations Asia Pacific-Taiwan, Asia Pacific-Australia Organization Janssen Korea, Ltd. (7220) Job Function R&D Requisition ID 2206021849W