Job Details
Job Details: Senior Director, Clinical Operations Planning and Study Delivery
Full details of the job.Vacancy NameVacancy Name
Senior Director, Clinical Operations Planning and Study DeliveryVacancy NoVacancy No
VN358Employment TypeEmployment Type
Full TimeLocation of roleLocation of role
Rockville, ConshohockenAbout the CompanyAbout the Company
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.Key ResponsibilitiesKey Responsibilities
Clinical Operations (ClinOps) is responsible for the worldwide execution of all IMCR clinical trials, across all phases. ClinOps plays a key role in ensuring all IMCR clinical trials are performed in accordance with applicable regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of IMCR s products.The Senior Director is accountable for the continuous optimization, harmonization and innovation of Clinical Operation s ways of working. The leader of this group has thorough knowledge of our evolving landscape and identifies gaps, performs root cause analysis, and drives process and system improvements forward. The Sr. Director of Planning and Study Delivery leads a team of Clinical Operations support functions that provide support across the different portfolios, including Study Feasibility and Study Start-up; Lab Management, Systems Management; as well as the Patient engagement team. This role is also critical to ensuring adequate and knowledgeable resources are in place for optimal delivery of the portfolio through the successful execution of the goals and deliverables outlined in the corporate and program goals.
This role is a member of and partners with the Clinical Operations Leadership team to understand the portfolio delivery strategy and translate that strategy into operational planning while driving continuous improvements and change management. The role is responsible for the harmonization of related business and operational processes between all teams and partners with the Clinical Operations Leadership Team to develop, execute, and deliver short and long-term strategic objectives.
The Senior Director is responsible for fostering a collaborative culture and works with many internal and external stakeholders to achieve desired outcomes. The person in this role serves as a visible and effective change agent for global initiatives and seeks to provide strategic decision making for all areas of responsibility while nurturing the ideas of others.
As a member of the Clinical Operations Leadership team, the person in this role is responsible for the review and approval of Clinical Operations strategies, SOPs and written standards, as well as a key contributor to issue review and recommendation/resolution processes. The role serves as a champion and leader for staff change management and engagement strategy, continuous improvement projects that promote individual development, team development, development of institutional knowledge, and best practices for leveraging the entire Clinical Operations network in an optimal manner.
The Senior Director is accountable for resource management across assigned areas, including ongoing assessment of resource needs and optimal deployment of resources to support a flexible ClinOps workforce. In addition, this role serves as an expert resource by offering input / ideas to solve operational challenges to include process improvement; technology solutions; and overall improvement in workflow cycle times. They are a member of the Clinical Operations Leadership Team and support their peers and key stakeholders by contributing to the strategy and/or management of the broader organization. They lead Clinical Operations and/or cross-functional organizational initiatives and strategies that promote change management to accelerate adoption. They typically act as the business process owner (BPO) and/or serve as a subject matter expert for complex Clinical Operations processes. He/she demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations.
Essential Duties And ResponsibilitiesManage and lead a team across Clinical Operations key functions and roles: feasibility and start up, lab management, system management, Patient engagement; as well as other Clinical Operations supportive roles.Ensure appropriate level of qualified and trained resources within assigned groups to support study delivery within the deadlines, budgets, and quality, according to ICH/GCP, company control documents and regulatory requirements.Responsible for the development of optimized practice development, roll out and training related to the Clinical Operations roles across Therapeutic areas and programs.Responsible for setting and implementing management monitoring of effectiveness of all roles within remit.Ensure that a high level of Quality Control (QC)is embedded in the team s day to day activities.Ensure harmonization at task/activity/process level for all staff within remit.Drive the implementation of new practices and best practice sharing.Define and analyze resource requirements as per study projections and business needs in collaboration with team and Clinical Operations leadership.Ensure resource prioritization according to business priorities and corporate objectives.Drive innovative approaches to study delivery through external facing advances in technology and science.
Supervisory ResponsibilitiesRecruit, retain, lead, and develop a team of key clinical operations supportive staff: start up and feasibility, lab management, system management and other support functions, all while supporting study delivery across the portfolio.Lead and direct staff by providing key objectives aligned to company vision and strategy, setting clear objectives, expectations and feedback on performance, and opportunities for development, coach and keep staff motivated during heavy workload and changing priorities.Establish performance measurements for all staff track, perform and identify corrective actions.Contribute to staff capability building by supporting onboarding and community forums.Ensure robust performance and talent management processes in place and implemented.
Education/ExperienceBS/BA degree in related disciplineTypically requires a minimum of 15 years of significant experience in managing clinical operations with strong knowledge of ICH/GCP and Regulatory requirements driving clinical development.Experience in People Management and leading teams, to include management of resources from different sources in different locations (internal, external, functional service providers).Experience in Biotech/Pharmaceutical industry preferred.
Knowledge/SkillsCreative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.Proven clinical development experience across all phases of development (I-IV).Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.Demonstrated ability to develop and lead the execution of strategy and business transformation and initiatives.Change management experience.Experience in assessing technology, external environment & R&D process requirements to successfully drive operational productivity, strategy optimization, process improvements and efficiencies.Strong knowledge of ICH-GCP and Regulations.Able to manage and lead teams across multiple locations; leads by example and promotes collaboration, effective communication, and leadership in others.Strong communication and presentation skills including strong ability to network and negotiate at all levels in the organization.Broad understanding of the biotech / pharmaceutical industry and the clinical development process.
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