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The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals’ clinical development programs across clinical study phases pre- and post-authorization.

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A Typical Day In This Role Looks Like • Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study, • Provides operational input into protocol development, • Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc., • Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc., • Ensures compliance with the clinical trial registry requirements, • Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, • Provides input into baseline budget development and management, • Provides input into baseline timeline development and management, • Leads risk assessment and identifies risk mitigation strategies at the study level, • Leads the feasibility assessment to select relevant regions and countries for the study, • Oversees/conducts site evaluation and selection, • Leads investigator meeting preparation and execution, • Monitors progress for site activation and monitoring visits and acts on any deviations from plan, • Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan, • Monitors data entry and query resolution and acts on any deviations from agreed metrics, • Ensures accurate budget management and scope changes for internal and external studies, • Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation, • Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues, • Oversees the execution of the clinical study against planned timelines, deliverables and budget, • Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites, • Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work, • Ensure clinical project audit and inspection readiness through the study lifecycle, • Supports internal audit and external inspection activities and contributes to CAPAs as required, • Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability, • Contributes to clinical study report writing and review, • Facilitates and contributes to study level lessons learned, • Assigns tasks to Clinical Study Management staff and supports their deliverables, • Recommends and participates in cross-functional and departmental process improvement initiatives, • Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs, • May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring, • Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight, • May require 25% travel This Role May Be For You If You Have • Exceptional interpersonal & leadership skills, • Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies, • Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving, • Advanced communication skills via verbal, written and presentation abilities, • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization, • Ability to influence and negotiate across a wide range of stakeholders, • Strong budget management experience, • An awareness of relevant industry trends, • Ability to build, lead and develop productive study teams and collaborations, • Applies advanced negotiation and interpersonal skills to vendor management, • Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, • Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents, • Knowledge of ICH/GCP and regulatory guidelines/directives, • Advanced project management skills, cross-functional team leadership and organizational skills, • Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation-inspiring complex change, enabling organizations to grow, building competitive advantage, and driving bottom-line impact. To succeed, organizations must blend digital and human capabilities. Our diverse, global teams bring deep industry and functional expertise and a range of perspectives to spark change. BCG delivers solutions through leading-edge management consulting along with technology and design, corporate and digital ventures—and business purpose. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, generating results that allow our clients to thrive. What You'll Do As a Senior Manager – BCG Vantage on our Topic Activation path within BCG's Risk & Compliance (R&C) Practice Area (PA), you will deliver against client and commercial priorities for Non-Financial Risk Management ('Topic'). Part of the role is acting in a consulting capacity to case teams and the remainder managing assets, IP, tools and team processes. You will grow and deploy a team of experts to directly support client case work, content development and business build initiatives. You will drive the Intellectual Property (IP)/content agenda for your topic, including the building of technical tools, with support from internal information technology colleagues. You will be responsible for the team’s performance across all key performance indicators (case billability, quality, content creation, etc.). You will also be the team lead for the Request Management process; a workflow process that facilitates case teams' support from the R&C Vantage team, ensuring that there is a clear internal team process for task assignment, completion and recording. You will also be responsible for reviewing requests on a periodic basis to identify trends and insights that will influence team strategy. You will be the lead in the team to track the development of all IP across the team, having a clear IP development strategy, that is effectively managed, executed and results In delivery of the tools on case work by the responsible team members. The R&C PA helps clients to manage key risks strategically, to advance organizational resilience and establish a profound risk culture, by defining and transforming R&C operating models. We cover a diverse set of topics across financial and non-financial risks, and assist in enabling clients' strategy through technical enablement with the help of our deep expertise in risk modelling, analytics and digitization. As a Senior Manager – BCG Vantage, you will engage with case teams & clients based on your individual expertise and demonstrate differentiated impact and value-add to BCG clients and case teams. As a Non-Financial Risk Management expert, you will be familiar with risks that can significantly impact on an organisation’s resilience, reputation, and long-term value. You will be comfortable with, and able to flex between, the following risks: Strategic Risk (risks related to flawed strategies, geo-politics, security or poor decision-making), Operational Risk (failures in internal processes, systems, or human errors, including Third-Party & Outsourcing Risk (dependency on vendors and suppliers)) and Compliance & Regulatory Risk (breaches of laws, regulations, or internal policies). You will understand how risk management and compliance functions are organisied and the management information approach to report on risks to risk committees. You will be experienced in organisational risk management processes, including risk assessment methodologies, risk appetite and risk tolerance setting, Compliance monitoring, Issues Management, Corrective Action Plans, Controls design / testing and Key Risk Indicators. You will be technologically savvy, able to interface easily with technical teams and be familiar and inquisitive with all things Artificial Intelligence (AI) as it relates to risk management, including the build and use of AI tools in second line of defence functions and also the risk management of AI. Familiarity using risk management technical tools ('risk tech' and 'reg tech') is desirable. Previous experience supporting heavily regulated corporates through a period of regulatory scrutiny or transformation would also be valuable. • Leading problem solving and solutioning for clients and driving towards pragmatic solutions tailored to the business context, • Leading development and commercialization of knowledge and assets e.g. tools, including non-financial risk management frameworks, target operating models, and cost optimisation scenarios, • Engaging and communicating with senior stakeholders, demonstrating expert presence and credibility, • Leading projects in a highly effective manner, mobilizing the team to deliver on business priorities and commercial impact, • Acting as a highly effective coach and mentor, guiding team members to achieve goals efficiently and effectively an ambassador for the team and role model for team members, • Working in an ever changing and complex environment, and comfortable with ambiguity and navigating a fast-paced environment, • Staying current In your topic and forward thinking with regards to market trends, • Working autonomously, understanding nuances and hierarchies in the operating environment, • Innovating, ideating and taking a proactive approach; applying yourself to the task at hand, even if the task is not necessarily a direct responsibility of the role - a great team player What You'll Bring • Bachelor's degree (or equivalent) required, (advanced credentials preferred); namely a senior qualification in risk management such as the Level 5 - International Certificate in Enterprise Risk Management, the Certified Risk Professional designation and / or a Fellow of a Risk Management Institute (not exhaustive), • 5+ years consulting experience in non-financial risk management In financial services and one other sector required; candidates with consulting experience preferred, • In lieu of consulting experience, 7+ years minimum industry experience required; 10-12+ years of industry experience strongly preferred, • Tenures of at least 2 years in a second line function (ideally Operational Risk) or a 1.5 Line function ('in business risk and controls') focused on operational risk processes. Risk management experience in a number of corporate entities, • Specialization in relevant non-financial risk management in banking and at least one other sector, • Experience in coordinating, collecting and managing workflow processes, • Fluency in English; added extra if fluent in any or all of these: German, Spanish Italian, • Exceptional attention to detail. You ensure superior quality work output of yourself and others. You build trust and establish a reputation for thoroughness and integrity. You deliver strong people leadership, to provide a best in class team experience, • Outstanding interpersonal and communication skills to interact with, and manage internal and external stakeholders, while working in a global collaborative team environment, • Solid commercial acumen Who You'll Work With As a Senior Manager – BCG Vantage on our Topic Activation path, you will collaborate with global topic leads and colleagues across BCG to bring expertise and capabilities to the service of our internal and external clients. Our team is made up of a diverse pool of BCG Vantage positions that allow us to pursue exciting, innovative BCG Vantage careers. Boston Consulting Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity / expression, national origin, disability, protected veteran status, or any other characteristic protected under national, provincial, or local law, where applicable, and those with criminal histories will be considered in a manner consistent with applicable state and local laws. BCG is an E - Verify Employer. (Click here )( for more information on E-Verify.

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