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.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Clinical Operational Excellence. The position reports to the Vice President, Clinical Operations. The location of the position is in Brisbane, CA.
The Director, Clinical Operational Excellence oversees clinical operation processes and systems, training programs, and implementing appropriate standard processes and operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations. The Director may also sponsor and/or lead key strategic Clinical Operations organizational initiatives.
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
- Oversees the development 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
- Represents Clinical Operations on Inspection Readiness progress and activities
- Partners with Clinical Quality Assurance to oversee GCP regulatory authority inspections on behalf of Clinical Operations
- Provides oversight and strategic guidance 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
- Leads key strategic Clinical Operations 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
- Accountable for the management of any additional future Clinical Systems, Solutions, and Compliance staff or consultants
- Provides input to and rationale for department budget and maintaining control of functional expenditures against department budget as they relate to this role
- May develop and present strategic and operational plans to senior management
Core Competencies, Knowledge, and Skill Requirements
- Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines
- Experience in preparing teams for GCP inspection readiness as part of NDA/MAA activities, including creation and organization of eTMF and document management
- Strong sub-team leadership skills with managerial experience
- Proven experience handling confidential and/or sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required
- Creative, flexible thinker with strong strategic planning and decision-making skills
- Ability to deal effectively with time demands, incomplete information or unexpected events
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
- Continuously demonstrates a positive, ‘can-do’ and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy
- Must have the ability to build and maintain positive relationships with senior management, peers, and other colleagues
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
- Ability to manage multiple responsibilities and shift priorities quickly while working under tight deadlines
- Skilled in developing collaborative internal and external relationships
- Required skill in the operation of standard office equipment including: computers (common software programs), copy machines, and other equipment as necessary
- Excellent verbal and written communication skills, as the position will interface with employees, vendors, and other external people.
- Ability to ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross-functional Development processes, clinical systems, quality documentation and training programs, as appropriate
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline required
- At least 15 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: GCP regulatory authority inspections, process development and improvement, training and development, development of a clinical compliance function, and clinical systems, and managing people
- Experience developing and leading a clinical risk management function and the ability to demonstrate an understanding of a clinical quality management system
- Previous experience in leading a function or business unit, including the management of related budgets, timelines, and resources
- Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
- 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
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
- Willing to travel domestically and internationally approximately 20% of time, per business needs
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 email@example.com.
Equal Employment Opportunity