Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
The Associate Director, Clinical Operational Excellence leads cross functional working groups to optimize clinical processes and systems, training programs, and standard operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations. The Associate Director may also sponsor and/or lead key Clinical Operations organizational initiatives. This individual reports to the Director of Operational Excellence.
Essential Duties and Responsibilities:
- Leads the creation, deployment, and management of Clinical Operations’ systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.
- Leads cross functional teams in the development, review and revision and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP guidelines and company policies to ensure inspection readiness.
- May represent Clinical Operations on Inspection Readiness progress and activities.
- Partners with Clinical Quality Assurance and department leaders to embed quality and GCP compliance within our day-to-day activities.
- Work collaboratively within Clinical Operations in support of Inspection activities.
- Provides oversight for key clinical systems, such as eTMF and document management.
- Actively participates as a member of the Clinical Operations Leadership Team in the development and execution of organizational initiatives, goals, and strategies.
- Supports key strategic Clinical organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancements, and training.
- May develop and present strategic and operational plans to senior management.
Core Competencies, Knowledge, and Skill Requirements
- Experience in setup, execution, and operational management of domestic and international Phase 1, 2, and 3 clinical trials
- Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines
- Experience participating in or preparing teams for GCP inspection readiness as part of NDA/MAA activities
- Demonstrated leadership capacity in a cross-functional project environment.
- Creative, flexible thinker with strong planning and decision-making skills
- Ability to deal effectively with time demands, incomplete information or unexpected events.
- Detail-oriented with a commitment to accuracy
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred; advanced degree preferred)
- At least 10 years of experience in Clinical Research, with a focus on biotech and/or pharmaceutical Clinical Operations
- The ideal candidate will have demonstrated ability in the following additional areas: Study execution, GCP inspections, process development and improvement, training, and development.
- Experience developing SOPs and processes associated with the conduct of clinical studies and strong knowledge of clinical quality management systems.
- Previous experience focusing on practical, commonsense, and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors.
- Experience working in a fast-paced, dynamic corporate environment.
- Previous experience leading key strategic functional initiatives.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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Equal Employment Opportunity