com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and are in adherence with corporate and departmental Standard Operations Procedures. The Director will also manage career development of multiple direct reports within clinical operations group._Your Contributions (include, but are not limited to):Design and implement clinical strategies using internal and external resourcesProvides leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)Lead the tactical implementation and execution of the clinical development process (all phases) primarily for selected programsEnsure these activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures (SOPs)Establish and manage overall clinical program budgets as well as individual study budgetsDevelop and maintain clinical trial timelines to achieve corporate goalsCreate and establish critical metrics to benchmark activities to develop and revise performance to reach and maintain highest possible standards of excellenceIdentify and introduce process improvements within clinical organizationManage relationships and expectations with CROs and other clinical contract service providers. Act as point of contact with external bodiesManage inter-department relationships (Regulatory, QA, etc) to ensure adequate support for clinical programs as well as provide input into cross functional meetings and documentationInterface with Medical Directors by providing operational input to clinical protocols, clinical development plans and clinical study reportsRecruit, train, and manage career development of multiple direct reports within the clinical operations groupManage operational activities of clinical programs with corporate partnersPerform additional tasks and duties as assignedRequirements: BS/BA degree in scientific or related field AND 12+ years of extensive experience with traditional progression in clinical research in pharmaceutical/biotech industry, or CRO or relevant experience required. ORMaster's degree in scientific or related field or MBA AND 10+ years of similar experience shown above. ORExtensive previous managerial experiences also requiredDetailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directiveAbility to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goalsExpertise directing global studies, particularly in endocrine related indications and/or rare diseasesStrategic vendor management skills, particularly CROs or similar complexityRecognized as an internal thought leader with extensive technical and business expertise within a strategic organizationApplies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovativelyEvaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impactAbility to work independently and cooperate and collaborate with a wide variety of individuals, groups, and teamsAbility to effectively operate in a multi-level matrix environmentStrong organizational, interpersonal and leadership skillsStrong internal/external negotiation / influencing skills#LI-RS1Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. SummaryLocation: UK LondonType: Full time
Project-менеджер (remote) in London employer: Neurocrine
Neurocrine Biosciences is an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of neuroscience. With a commitment to employee growth, we provide ample opportunities for professional development and advancement, all while working in the vibrant city of London. Our focus on brave science not only drives our mission but also creates a meaningful and rewarding environment for our team members.
