Sr Process, Standards, & Training Manager

SUMMARY/JOB PURPOSE: This role supports the effort of process, standards, and training for the optimization of Development Operations functions including: Biostatics, Clinical Operations, Clinical Data Management, Programming, and Clinical Technology Solutions. Collaborates with department management to support the development or updates to standard operating procedures (SOP), work instructions (WI), process maps, and other process-related documents and tools. Leads initiatives on continuous improvement that are cross fuctional, end-to-end (E2E), and compliant Supports development of training materials and competency measures to ensure compliance with Department and Company policies and help promote a learning environment within Development Operations in order to support staff growth and development while ensuring compliance ESSENTIAL DUTIES AND RESPONSIBILITIES: Partners with the business on continuous improvement initiatives Co-leads Development Operations training curricula activities Partners in Root Cause Analyses and CAPA’s Advises on content for training and knowledge management initiatives Identifies and supports remediation issues related to training assigned to Development Operations functional areas Partners to design, develop, and implement Development Operations departmental procedures, work instructions, guidelines, and process maps to ensure compliance with regulatory requirements and company policies Identifies and develops shared solutions across Development Operations for formal and informal competency development, and learning/knowledge sharing, to increase productivity and performance. Develops and reports metrics to reflect progress and status of conintuous improvement and training activities. SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in related discipline and a minimum of nine years of related experience; or, MS/MA degree in related discipline and a minimum of seven years of related experience; or, Equivalent combination of education and experience. May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: Typically requires a minimum or ten years of related experience or the equivalent combination of experience and education/training Typically requires a minimum of ten years of pharmaceutical/biotechnology/CRO in compliance management of clinical trials, training, clinical operations, project management Knowledge of ICH-GCP guidelines and applicable drug development regulations Experience with training development and implementation required Experience with inspection readiness Experience with process and training methodologies and design Ability to manage relationships in a matrix organization that is fast-paced Experience in supporting clinical trial GCP compliance/quality management activities Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials Knowledge/Skills: Expert experience with process mapping, training, training content development, and implementation activities required Ability to prioritize and multi-task successfully in a fast-paced and changing environment Excellent interpersonal and communication skills, both written and oral, including ability to develop strong relationships with internal and external stakeholders Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely Demonstrated ability to think strategically across the organization Self-motivated, calm under pressure, and adaptable to a dynamic environment with the ability to support successful change JOB COMPLEXITY: Applies judgement and professional expertise in new situations Independent team member performing highly technical or specialized work WORKING CONDITIONS: Ability to be onsite three times a week (currently Monday, Tuesday, Thursday) Office environment DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.