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 redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.
The Associate Director will lead cross functional working groups to optimize clinical processes and systems, training programs, and standard operating procedures (SOPs) to ensure program, individual, departmental and corporate goals and objectives are executed on time with quality and within budget in compliance with SOPs, applicable regulations, and ICH/GCP guidelines.
The Associate Director, serves as a member of the Clinical Operations Leadership Team, contributing to and leading departmental initiatives, working groups and department resourcing. This individual reports to the Director of Operational Excellence.
The Associate Director, Clinical Operations may also serve as the operations lead for a therapeutic area and provides strategic operational leadership and expertise to the program, and is accountable for financial planning and forecasting, driving timelines and assessing resource needs.
Essential Duties and Responsibilities
- Lead cross-functional teams in the creation, deployment, and management of Clinical Operations’ systems, processes, and Standard Operating Procedures (SOPs), and regulatory inspection-readiness activities in accordance with ICH/GCP guidelines and company policies
- Collaborate with Clinical Operations Leadership in the development, and deployment of Clinical Operations’ training programs
- Lead the Investigation Team in Clinical Operations Quality Incidents and Corrective and Preventative Actions (CAPAs) in partnership with Clinical Quality Assurance
- Partner across Clinical Operations to embed quality and GCP compliance within our day-to-day activities.
- Identify and drive process improvement initiatives in collaboration with cross functional leaders
- Keep current with clinical development and regulatory changes, technology trends and patient engagement
- Support key strategic Clinical organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments.
- Provide oversight and leadership of Clinical Operation study team(s) including in-house team members, Contract Research Organizations (CROs), and Clinical Service Providers (CSPs) to ensure delivery of studies and programs on time with high quality and within budget
- Lead the identification of program risks and work with Study Management Team (SMT) Lead and cross functional leaders to develop and implement risk mitigation strategies to enable trials to complete as planned with proactive communication to senior management stakeholders
- May develop and present strategic and operational plans to senior management.
- Champion a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization
- Experience in setup, execution, and operational management of domestic and international Phase 1, 2, and 3 clinical trials, experience with Post Study Access Programs a plus
- 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)
- Minimum 10+ years of relevant experience in biotech or pharmaceutical industry 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, department level training programs.
- Experience developing SOPs and processes associated with the conduct of clinical studies; and strong knowledge of clinical quality management systems, experience with Deviations and CAPAs a plus
- 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.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity