Director, Global Clinical Development Standards Steward

Job Description

Primarily responsible for the overall governance of the GCD Standards and SOP model, and implementation of training strategies (curriculum, training materials, training delivery and competency) through internal and external resources to ensure GCD (and FSP partners) have well-trained staff, equipped to perform clinical trial work.

Primary activities/responsibilities:

SOPs

• Responsible and accountable for the GCD Standards SOP Model - manage day-to-day SOP issues, competency plans, and overall process model

• Works with key leaders across our company (GCD, GRACS, CORE, TPharm, Ethics & Compliance, Legal, Privacy) to ensure SOP alignment and compliance. Work with global functions to address process, competency, and verification gaps that impact ability to be efficient while maintaining acceptable “compliance”

• Provides overall leadership for the SOP Model by working with Subject Matter Experts (SMEs) in the design, development, review, implementation and maintenance of SOP’s, work instructions, guidelines and process maps to ensure compliance with regulatory requirements and our company's policies.

• Accountable for management of the GCD Standards collaboration spaces and documentation, as well as continuous improvement for users (aligned with our company's Standards).  Supports alignment of SOP catalogs across GCD (e,g. BARDS, GDMS, Country).

• Represents GCD for cross-company SOP standards, competency and verification activities

LEARNING & DEVELOPMENT TO SUPPORT GCD STANDARDS

• Leverages our company's Learning and Development’s competency tools/approaches to learning for GCD. Aligns actions with training plans, and understands and evaluates the potential impact of external events on the organizational/training strategies.

• Collaborates with our company Learning & Development in the development and implementation of role-based training curricula.  

• Manages development of metrics to monitor training curriculum effectiveness, adjusting plans as appropriate to deliver improved performance. 

• Ensures that training maximizes competency with performance-based metrics tied to quality results.

• Focuses on delivering on a few high-impact opportunities by implementing therapeutic area specific approaches based upon their needs and preferences.

• Leads and influences trainers and training leaders through modeling and coaching to our company's leadership capabilities.

• Holds final accountability for all content of GCD Standards learning assets.

• Ensures that training maximizes competency with performance-based metrics tied to quality results.

GENERAL

• Manages junior level GCD Standards & Training staff

• Inspires ownership, accountability, and engagement within the team by regularly communicating GCD vision, business objectives, performance outcomes, and future steps.

• Develops people and the organization by investing in long-term development of others through mentoring, coaching, and continuous feedback.

• Creates a climate of trust so team members can act decisively by clarifying roles/responsibilities and establishing boundaries of decision-making.

• Establishes business objectives, assesses performance, and addresses skill development to ensure appropriate portfolio management, including opportunities for career development.

EDUCATION

• Required: Bachelor’s degree

• Preferred: Master’s degree

EXPERIENCE

• A minimum of 15 years Operations management experience in a regulated industry.

• Strong, demonstrated leadership skills to drive initiatives.  

• Ability to successfully apply and display mastery in Process Excellence methodology (Metrics, Design of Experiments (DOE), Six Sigma and Lean).

• Strong analytical problem-solving skills.  

• Project management experience. 

• Strong business acumen - excellent oral and written communications skills. Must have a strategic mindset.

• Ability to collaborate effectively with all levels of management and influence decision-making in a cross-functional team environment.

PREFERRED

• Green or Black Belt Certification in Lean or Six Sigma. 

• People management experience.

NOTICE FOR INTERNAL APPLICANTS

In accordance with