Nektar Therapeutics
Position Overview
Nektar has an exciting opportunity for an Associate Director, Clinical Training to join their team.
The Associate Director (AD), Clinical Training leads and supports training activities within Development Operations and across clinical development, when needed.
This role is the designated Development Operations business system administrator for Compliance Wire and Master Control.
The role manages the development of training strategies, methods and implementation.
The AD is responsible for creating Development Operations training materials and conducting and/ or facilitating training sessions for staff, new-hire onboarding, and study specific processes, as needed.
The role develops and maintains methods for evaluation of training effectiveness, through the use of metrics and surveys.
This role may be called upon for programs such as new employee orientation, performance management and/or organizational development training.
Specific responsibilities will include:
Works on complex problems or data requiring an in-depth evaluation of various factors.
Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
Establishes and assures adherence to budgets, schedule, work plans, and performance requirements.
Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
• Interfaces with all GCP groups to provide management, support and oversight of training compliance.
• Provides leadership in the continuous improvement of the Training program, according to GCP and current industry standards.
• Assists in the development of compliance and effectiveness metrics.
Provides training compliance and effectiveness updates to functional leaders.
• Ensures support of company priorities including regulatory inspections and internal audits.
• Provides support with documentation, tracking and archival of training processes and initiatives.
• Responsible for serving as the Development Operations Department Training Coordinator (DTC) for NEKTAR’s Learning Management System (i.e.
Compliance Wire).
• Develops training for procedural documents including instructions courses, quizzes, exams and other training materials.
Coordinates their development and maintains associated training curriculum with functional area input.
• Responsible for the design and development of content and formatting of training materials for effective adult learning.
Responsible for organizing and presenting training sessions to groups or individuals.
• Ensures training and related documentation is appropriately captured and recorded within Compliance Wire.
Responsible for group and individual training sessions, including scheduling, training material/media development, presentation and record keeping.
• Participates in Learning Management System (LMS) administration.
Responsible for management of study-specific training assignments in Nektar’s LMS, in collaboration with the Clinical Trial Lead.
• This role will be responsible for supporting Development Operations in Master Control, including maintenance of procedural documents across clinical development which may entail routing and approval of procedural documents and facilitating periodic reviews.
Professional Qualifications:
A Bachelors degree in Training and Development or related discipline is required. Equivalent experience may be accepted.
A minimum of 10+ years experience in general training, GCP training or other related function is required.
A minimum of 8+ years previous management experience is preferred.
Experience working in the Biotech, Pharmaceutical or other related industry is preferred.
Experience in a GCP setting and demonstrated success in establishing GCP training systems are highly desired.
Must possess excellent project management skills.
Strong verbal and written communication and presentation skills are required.
Must be goal-oriented, quality-conscientious, and customer-focused.
Must have experience delivering training courses to diverse audiences.
Experience working in a team-focus environment is preferred.
Must possess experience in needs assessment, design, preparation, delivery, follow up and tracking the desired outcomes of training and development programs for company management and employees.
Computer literacy (MS Word, Excel, PowerPoint, Visio) is required.