Associate Director, Clinical Operational Excellence
Company: Myovant Sciences Ltd.
Posted on: February 25, 2021
Associate Director, Clinical Operational Excellence 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.
Position Summary: 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
- 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
- Work collaboratively within Clinical Operations in support of
- Provides oversight for key clinical systems, such as eTMF and
- 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
- 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
- Creative, flexible thinker with strong planning and
- 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
- 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
- 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. If you require any
accommodations, please email firstname.lastname@example.org. How did you hear
about this job? If an employee referred you, please indicate their
Keywords: Myovant Sciences Ltd., San Francisco , Associate Director, Clinical Operational Excellence, Executive , Brisbane, California
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