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.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director/ Director, Early Clinical Development Operations located at our Brisbane office. This position will manage the operational aspects of clinical studies on both a portfolio and individual level. On a portfolio level, support the development of early development plans and strategy include financial forecasting/ budget reconciliation, business development/ procurement, vendor management and contracting. As the operational lead for individual studies, the individual serves as the primary point of contact for contract service providers involved in all study aspects and is responsible for obtaining RFPs, setting up MSAs and contracts.
Essential Duties and Responsibilities
- Develop or contribute to the development of SOPs, workflows and/or business practices, oversee training requirements and compliance and financial forecasting for projects and staffing plans.
- Responsible for ensuring that the execution of all study aspects follow Myovant SOPs, protocol, ICH/GCP, and applicable regulatory requirements.
- Review and approve clinical study reports in accordance with overall project timelines.
- Collaborate with internal and external scientific and medical experts, to plan and execute studies that support Early Clinical Development strategies and plans.
- Manage CSPs, interact with investigators and study site staff to execute clinical trials in accordance with contracted scope, costs and timelines; actively engage with CSPs on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities
- Identify risks to clinical study execution success, proactively communicate risks to internal and CSP teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete as planned
- Author, review and/or manage a wide variety of activities, including clinical study synopses and study protocols, informed consent forms, case report forms, study reference manuals, monitoring plans, data management plans, site initiation visit meeting presentations.
- Prepare Request for Proposal (RFP) documents and with cross-functional project team, solicit and evaluate bids; lead contracting process with selected CSPs, collaborating with relevant departments such as Legal and Finance, including purchase order requisitions and routing contracts for approval
- Manage internal teams to ensure database lock activities occur in a timely manner, coordinate activities for delivery of top-line data.
- Keep current with clinical development and regulatory changes, technology trends and patient engagement
- Other projects when assigned.
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
REQUIREMENTS (Education and Experience)
- BS degree (MSc preferred) in a science-related field of study (eg, biology) or is a registered nurse (RN) or with minimum 5 years in a Clinical Operations/Trial leadership role
- Minimum 10+ years of relevant experience in biotech or pharmaceutical industry
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
- Demonstrated track record in conducting clinical trials in an out-sourced model
- May travel periodically to investigator meetings and individual sites as needed
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