Clinical Operations Program Head

5 days ago


Dublin, Ireland Novartis Ireland Full time

OverviewJoin to apply for theClinical Operations Program Headrole atNovartis Ireland.The Clinical Operations Program Head (COPH) is accountable to deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated trials by representing GCO at the Global Clinical Team (GCT) as well as at the Global Program Team (GPT).The COPH is accountable to plan the strategic operationalization of clinical drug development programs and trials in line with the needs of the EPTs/GPTs.This role may be focused within Immunology, CRM or Neuroscience programs.The COPH leads the GCO sub-team to determine the GCO operational input to planning prior to any given development tollgate and to prepare the Operational Execution Plan (OEP), authored and owned by the COPH.The OEP incorporates data-derived insights as well as country insights to enable informed decision-making, identify complexity, generate risk mitigation plans to reduce delays, enable easier action adaptation, and ensure transparency of the GCO operational position and the downstream delivery of program and trial milestones.The COPH owns the early viability assessments and program and trial feasibility of the planned programs and trials.During trial execution, the COPH will lead the GCO sub-team to ensure progress aligns with the OEP and to deploy mitigation actions to ensure timely delivery.The COPH is an experienced leader guiding members through the GCO organizational evolution, the evolution of new product-aligned ways of working, and our culture.He/she champions a product-oriented agile mindset, fostering a culture of experimentation combined with accountable delivery and high performance.Major accountabilitiesLead operational delivery of the clinical development program and the overall operational execution of the clinical program and related trials, as aligned with the IDP/CDP.Single GCO point of contact for the assigned clinical development program and related trials.Partner to GPCH during strategy, planning and execution, ensuring that clinical science and strategy are harmonized with an operationally feasible approach within the OEP-defined boundaries, so trials generate reliable information and support decision making while protecting participants.Lead the operational delivery of the assigned program and related trials, prioritizing activities within the program and owning early viability and feasibility assessments, as well as development of operational scenarios for execution.Oversight and management of the clinical trial budget for the assigned program and trials per the OEP and financial toll gates, including scope changes throughout the program.Collaborate with the GCO DU Head to shape the GDD DU strategy by driving the science of operations and ensuring the development strategy is operationally executable.Act as a key contact to senior leaders in GCO and beyond; manage stakeholders, resolve conflicts, and facilitate agreement.Monitor industry evolution and may represent GCO and Novartis at industry consortia.May participate in Early Program Teams to assess operational viability of new clinical programs and ensure GCO's assessment is reflected in program plans.With the GCO DU Head, ensure novel programs are reflected in mid- to long-term GCO strategy and readiness for operationalization.The COPH champions a product-oriented agile mindset and a culture of experimentation with accountable delivery and high performance.Essential RequirementsBachelors in life science/healthcare required; advanced degree (PhD/MD/PharmD/Master) preferred plus 10+ years of relevant pharmaceutical drug development experience.Experience in managing associates globally within a matrix organization.Proven ability to lead cross-functional matrix teams using product-oriented agile methods.Strong leadership, interpersonal and problem-solving skills; high resilience and ability to drive new ways of working.Extensive knowledge of clinical development processes; preferably extensive knowledge of Novartis late-stage development or ability to develop it within 6 months.Proven ability to lead in times of organizational transformation and across boundaries.Strong knowledge of a therapeutic area or ability to develop it within 6 months; strong matrix management skills for bridging stakeholders.Strong relationship-building skills with the ability to influence, negotiate with and motivate executive leadership.Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life Handbook.Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to all individuals.If you need a reasonable accommodation for any part of the recruitment process, or for more information about the essential functions of a position, please email with your request and contact information.Include the job requisition number in your message.Why Novartis:Helping people with disease and their families takes more than innovative science.It takes a community of smart, passionate people.Collaborating, supporting and inspiring each other to achieve breakthroughs that change patients' lives.Ready to create a brighter future together?Join our network and stay connected for suitable opportunities: talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about the ways we'll help you thrive personally and professionally: novartis.com/careers/benefits-rewards#J-*****-Ljbffr



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