Director, Operations Portfolio Lead, Clinical Operations
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.Summary Description
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of the Director Operations Portfolio Lead (OPL) located at our Brisbane office reporting to the Vice President, Clinical Operations. This individual serves as the operations lead for one or more therapeutic areas and provides strategic operational leadership and expertise across the programs. The Director, OPL 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 Director, OPL 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 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
- Command of program status and proactively communicate issues or changes that may impact quality, timelines and costs to senior management stakeholders
- Champion 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
- Act as point of escalation and develop and maintain robust relationships with leaders within Contract Research Organizations (CROs) and other Clinical Service Providers (CSPs)
- Inspire and 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 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
- Resourcing and hiring: Coach and mentor direct and indirect reports while managing talent with succession planning in mind. Identify, recruit, hire, and develop Clinical Operations staff.
- Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by employees in reporting and other departments
- Willing to travel domestically and internationally
- Expert knowledge of clinical research operations, including interpretation and implementation of FDA and other regulatory agency requirements and ICH/GCP guidelines
- 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
- 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
- Excellent project management skills with ability to oversee multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment
- Able to problem solve, delegate appropriate tasks and/or develop junior team members as part of succession planning
- Expert stakeholder management, influencing and negotiation skills
- Direct line management experience in a leadership position with ability to coach and develop a team
- Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials
- Excellent team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly desired
- Experience with Inspection readiness for various Health Authority inspections, including FDA and EMA highly desired
- Required skill in the operation of standard office equipment including: copy machines/scanners and other equipment as necessary
- Demonstrated proficiency in MS Office (Outlook, Word, PowerPoint and Excel) and Smartsheets
- Able to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- A minimum 12-15 years of Clinical Trial experience with 8-10 years in a Clinical Operations leadership role in the biotech/pharmaceutical industry
- 4+ 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 firstname.lastname@example.org.
Equal Employment Opportunity