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Temporary Process, Standards, and Training Director at Exelixis, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Alameda, California





Job Description:

Position Description:
Support the Director of Process, Standards, and Training in implementing strategies and tactics that promote training and knowledge management for clinical trial activities performed by the Development Operations departments: Clinical Operations, Biostatistics, Clinical Data Management, Statistical & Clinical Programming. Collaborate with department management to revise training curricula. Leads efforts to develop 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.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Co-lead Development Operations training curricula activities.
• Partners in Root Cause Analyses and advises on content for training and knowledge management initiatives.
• Identifies and supports remediation issues related to training assigned to Development Operations functional areas.
• 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 training activities.
• Support Training, Process and Training Director in:
o Facilitating Biennial review of SOPs and WI
o Developing new processes to complement our maturing organization with expanded pipeline
o Collaborating with functional heads and Quality to refine role-based training curriculum
o Evaluating our CROs procedures with a formal gap assessment

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree or higher in related discipline and ten years of related experience.
• May require certification in assigned area.

Experience:
• 10+ years of related experience and/or combination of experience and education/training.
• 10+ years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Advanced experience with training development and implementation required.
• Experience with training methodologies and design.
• 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/Abilities:
• Advanced experience with training, training content development, and the rollout of processes 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

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.

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