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, Clinical Operations / Clinical Operations Excellence, located at our Brisbane office or remote. The position reports to the Executive Director, Clinical Operations Excellence & Operations, and serves as the operations lead for one or more therapeutic areas and provides strategic operational leadership and expertise across the programs. The Associate Director, Clinical Operations / Clinical Operations Excellence, Portfolio Lead, is accountable for the Clinical Operations financial planning/forecasting, development of program budgets, driving timeline development, and assessing resource needs for respective program(s). This individual will independently plan and lead programs, direct reports and cross functional teams, in order 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, Clinical Operations / Clinical Operations Excellence, Portfolio Lead serves as a member of the Clinical Operations Leadership Team, contributing to and leading departmental initiatives, SOPs, working groups and department resourcing.
Essential Duties & Responsibilities
- Provide oversight and leadership of Clinical Operation teams and CRO/Vendors and serves as a point of escalation, to ensure study progress, maintaining robust relationships with leaders within Contract Research Organizations (CROs) and other Clinical Service Providers (CSPs), to ensure delivery of studies and programs on time with high quality and within budget
- Experienced in leading cross-functional teams to develop and implement risk management plans, to ensure studies are completed timely and to the expectation of the clinical trial delivery, working alongside the Study Management Team
- Experienced in leading and mentoring clinical operations teams to achieve high potential and ensure consistent and collaborative efforts to delivery on the company goals and objectives
- Has deep knowledge of and technical skills to develop protocol, plans and deliverables to ensure studies are executed to the highest standards
- Demonstrate a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization
- Partner with cross functional stakeholders to identify and remove executional barriers in order to ensure timelines and goals are met
- Develop and maintain robust relationships with leaders within Contract Research Organizations (CROs) and other Clinical Service Providers (CSPs), to ensure delivery of studies and programs on time with high quality and within budget
- Lead efforts to deepen scientific knowledge within the Clinical Operations function
- Provide technical expertise for the development of protocols, monitoring plans, CRFs, clinical study reports, investigator brochures, etc. and trial conduct
- Lead Inspection Readiness activities for assigned programs and serve as the Clinical Operations SME for audits and inspections
- Partner with Clinical Business Outsourcing (CBO) on CRO/CSP selection process for outsourced activities including RFP development and review, bid defense meetings, CSP performance and issue resolution
- Identify and help drive process improvement initiatives in collaboration with cross functional leaders within the organization
- Keep current with clinical development and regulatory changes, technology trends and patient engagement
- Plan and manage budget proposals and approve budgets in accordance with Myovant’s strategic and operating plans and Finance policies
- Has expert knowledge of clinical research operations, including and understands regulations interpretation and guidelines such as ICH/GCP
- Experienced working on clinical trials in the US and globally
- Has the strategic ability to prioritize and plan respective delivery of company goals and objectives
- Experienced in project management and able to solve, delegate and ensure all tasks are completed
- Expertise in inspection readiness for FDA and EMA
- Excellent leadership skills, self-motivated, adaptable to a dynamic environment
- Strategic ability with forward thinking that effectively translates to a clear sense of direction for teams is essential
- Effective stakeholder management, influencing, problem solving and negotiation skills
- Direct line management experience in a leadership or team management position
- Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials
- Demonstrated leadership capacity in a cross-functional project environment
- Strong team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly effective teams is desired
- Detail-oriented without losing sight of the big picture
- Demonstrated proficiency in MS Office (Outlook, Word, PowerPoint and Excel) and Smartsheet
- Strong interpersonal, communication (verbal and written), analytical and organizational skills
- Able to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- Willing to travel domestically and internationally
REQUIREMENTS (Education and Experience)
- BS/BA degree or equivalent in relevant experience in biotech, pharmaceutical or scientific discipline with a minimum 10+ years of experience
- Clinical Trial experience with 8-10 years in a leadership role
- 5 years of direct line management experience
- Experience working within a small biotech company preferred
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
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