PpWork Your Magic with us! Start your next chapter and join EMD Serono. /p pReady to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. /p pUnited As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. /p pThis role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. /p h3Your Role /h3 pThe Compound Operational Lead (COL) is a global strategy program-level role within Global Development Operations (GDO). The COL will provide operational oversight, leadership and strategic input for the planning and execution of clinical program(s). In close partnership with cross-functional teams the COL will lead the clinical program, from First-in-human (FiH) to the final launch of the asset. /p pThe COL will drive faster, cost efficient, patient-centric trials that follow benchmarked industry standards that utilize "state-of-the-art" clinical project management methodologies aligned to global drug development processes. /p pThis role is accountable for the successful preparation and presentation of operational content at key governance discussions, ensuring critical operational input is provided to drive comprehensive, strategic, and thoughtful discussions for assigned program(s). /p h3Key Accountabilities /h3 ul liLeads the development of the clinical operational strategy (comprising of multiple trials, and/or multiple indications) and delivers the clinical development plan within the budget, timelines and quality standards agreed upon by Governance Committees. /li liRepresents GDO within the Global Program Team (GPT) and serves as the key GDO operational point of contact for the program. /li liAccountable for the successful preparation and presentation of operational content at key governance discussions (Development Unit (DU), Program Portfolio Governance (PPG), Integrated Protocol Review Committee (iPRC), Research Development Committee (RDCM), etc). /li liKey contributor to the development of annual program objectives and communicating to relevant line management. /li liDrives and leads the successful execution of all operational components of (a) global clinical program(s) using strong project management, leadership, and organizational skills. /li liEnsures strong oversight, review, and quality delivery of program CAPAs to meet corporate compliance standards and timelines. /li liProvides expert leadership and contribution to all operational aspects of the program budget, including oversight of individual trial budgets and forecasts to ensure delivery within the RD financial standards. /li liPerforms high-level review and provides input in the development of key clinical trial documents such as protocols and Clinical Study Reports (CSRs) and contributes to and/or reviews compound level documents such as Investigator Brochures, DSURs, briefing books. /li liProvides guidance and leadership support to Global CTLs and other cross-functional members within the assigned program/project. /li liFilters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operation and organizational challenges. /li liSupports the development and implementation of department initiatives including input on certain SOPs, processes, and workstreams. /li liManages large, diverse projects with high or even unique complexity. Leads a large diverse project team with members from multiple functions and a broad span of levels and roles or even disciplines. /li liAccountable for successful project execution and organizational learning. Controls sizable resources and works independently. Also defines team organization, roles, and responsibilities as well as budget. /li /ul h3Strategic Impact /h3 ul liContributes to the overall strategic decisions for a program(s) and drives the clinical operations aspects of the strategy within the cross-functional program team and various clinical sub-teams. /li liDevelops innovative clinical operation strategies (including patient access and feasibility plans) across multiple indications, trials, and geographies. /li liLeverages strategic knowledge and serves as subject matter expert across TA portfolio for current drug development/clinical trial management processes, regulations, and therapeutic knowledge. /li /ul h3Matrix Management of People /h3 ul liLeads the Clinical Operations Team (and potentially multiple teams or a sizable team of professionals/managers/team leaders) and is accountable for the performance and results of the team within a matrix environment internally and externally. /li liAssess resource needs and makes recommendations for allocations across the program(s). Contributes to setting team member objectives, coaching, and developing employees, performance appraisal feedback. /li /ul h3Who You Are /h3 h3Minimum Qualifications /h3 ul liCandidate must have a minimum of a BA or BS degree; Advanced degree in Life Sciences (such as a graduate degree) (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent medical background. /li /ul h3Preferred Qualifications /h3 ul liAt least 12-15 years of direct experience with independently leading and managing very complex global clinical trial program(s) across multiple indications in the pharmaceutical industry plus 5-7 years in a senior leadership position directing the operations of a large-scale global team and developing and mentoring junior/mid-level team members in matrix environment. /li liRequires extensive project management experience in potentially diverse project settings. Also requires (considerably) deep and broad expertise combined with in-depth knowledge of competitors as well as challenges and developments in the industry to achieve objectives and to identify business opportunities. /li liStrong leadership competencies and influencing skills with senior leaders and cross functional leaders. /li liEffective oral and written communication skills to influence, inform and guide a large scale global operational team. /li liBroad clinical operations experience and strong project management skills /li liProven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams. /li liComprehensive expertise in drug development, including profound knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical pharmaceutical development, regulatory, commercial/ marketing) /li /ul pOther Requirements: This position is hybrid, requiring regular onsite presence (typical schedule: 3 days in office and 2 days remote). /p h3What we offer /h3 pWe are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! /p pApply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! /p /p #J-18808-Ljbffr