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Director, Clinical Operations, NA
Nestlé Health Science (NHSc) is a company on a mission and on the move, motivated by the opportunity to forge a major therapeutic role for nutrition in the management of health and establish a new industry between food and pharmaceuticals. The two elements of the equation are simple; societies are ageing and age and lifestyle related diseases are spiraling. Needs are growing for safe, effective and cost-effective solutions. At the same time, scientific understanding of health, disease and the potential of nutrition – as an integral part of managing health and disease – is growing.
Nestlé Health Science, a wholly-owned subsidiary of the Nestlé Group, was created in 2011 to be a leader in these developments and make things happen. We have over 3,000 employees around the world with a wide mix of capabilities – from bio-medical engineers to regulatory specialists, medical delegates (sales force) and health economic experts that reflect our dynamism and intent to create.
Position Dimensions / Scope
Provide Clinical Operations leadership to all NHSc sponsored clinical trials in North America (NA). Will lead a clinical operations team, including direct oversight of CPMs and CRAs in NA to manage multiple clinical trials, including oversight of CROs, vendors, and consultants. Will have oversight of NA Clinical Operations budget up to $5M.
Main Purpose of Job
Head of NA Clinical Operations is accountable for all operational and strategic aspects of Clinical Operations in NA, supporting product development activities and clinical decision making to drive complex clinical trials with regulatory and drug development pathways. The candidate will provide Clinical Operation leadership and guidance with the development and implementation of strategies supporting timely completion of clinical trials with high data quality and rapid regulatory approvals of products for NHSc. Oversee execution of NHSc NA clinical trials are on-schedule and within quality standards and operational budget, including compliance with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice.
Manage and oversee execution of clinical trials to ensure quality, and timely delivery of results. Utilizes highly developed project management skills to lead and co-ordinate all clinical trial activities from study protocol to the delivery of clinical study report
Supervise, coach and develop Clinical Project Managers. Ensure appropriate competence level of all team members (recruitment, training, coaching) Mentor and contribute to personal development of CPMs and clinical operations staff In collaboration with Clinical Development, lead and co-ordinate the Evidence Development Plans ensuring alignment of the clinical trials to commercial strategy and claims Provide critical reviews and inputs of clinical operational aspects for development of Evidence Development Plan and Protocol Outline at the early stage of development Suggest realistic timelines and appropriate operational model Evaluate potential risks and propose mitigation plans
Provide clinical operations representation and leadership in the area of clinical trial design and analysis, including protocol development, Statistical Analysis Plan (SAP) and clinical study report (CSR); Participate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publication Oversees all clinical contracts in NA to provide timely and accurate input into financial management systems based upon agreed clinical project budgets. Manage NA Clinical Operations resources and budget. Supervise internal and/or contract clinical operations resources, and oversee/manage clinical vendors, including CROs Participate in defining the strategy, structure, budget management and organization of Clinical Operations department. Develop a strong NHSc Clinical Operations footprint in NHS Bridgewater
Qualifications & Requirements
EXPERIENCE AND EDUCATION REQUIREMENTS:
Bachelors degree required (PhD preferred) with 15 years of clinical trial management and operations experience in the pharmaceutical or biotech industry, including a minimum of 8 years of direct management experience of clinical professionals with increasing levels and/or breadth of responsibility.
Travel Requirement: Approximately 20% within the U.S. and International.
Oversee and lead management of all areas of NA Clinical Operations to ensure execution of NHSc clinical trials on-schedule and within quality standards and operational budget. Ensures cost, quality and timeliness of programs aligned with plans. Develop and execute clinical trial operational strategies which are in compliance with cGCP regulations and aligned with business development and strategic plans. Recommend and implement innovative clinical operational processes to support clinical programs. Oversee the clinical project management throughout the clinical study life cycle. Develop and manage clinical operations plan and departmental operating budget and responsible for creating the infrastructure to support NHSc clinical trials in the NA Responsible for recruiting, developing, training and retaining the clinical operations team including contractors. Ensures prioritization of activities and resourcing is in line with clinical plans. Drives for operational excellence. Fosters a collaborative, highly integrated culture. Develop and/or review clinical protocol designs, statistical analysis plans, clinical QA plans, study reports and data management plans to ensure compliance with cGCP regulatory guidelines. Responsible to ensure current, accurate and timely reporting for all IND annual reports and investigational brochures for regulatory submissions. Evaluate and approve standard operating procedures that impact clinical trial execution. Create and develop appropriate metrics to assess clinical trial performance, compliance and cost effectiveness. Monitors these metrics to evaluate clinical organization and current trials. Work with internal and external medical, scientific and operational experts to keep current knowledge of industry standards. Provides clinical operations perspective to cross functional teams. Participate in development of global strategic plans.
1. Core knowledge of the 10 Principles and expert knowledge in our areas of responsibility. - Expert knowledge of tools of trial management, CTMS, EDC etc. - Expert knowledge of ICH Good Clinical Practice. - Excellent knowledge of (multiple) county regulatory procedures. - Knowledge of Nestlé Management and Leadership principles. - Knowledge of Nestlé Clinical Trial process. - Educational background in biological science or other relevant science. - Understanding of R&D structure & environment especially in relation to clinical trials.
Key competencies include: - Team Leadership - Protocol development - Regulatory submissions - IND/NDA & drug development experience in Pharma setting - Therapeutic area and protocol training - Trial management for phases I-IV studies including pediatric trials - CRO/vendor management
Candidates must have strong leadership ability, exceptional communication and interpersonal skills, ability to work in a dynamic environment, multi-task and prioritize work. Must have full working knowledge of cGCP regulations and desirable clinical development and biostatistics knowledge, including regulatory submissions for product approvals.