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 Vice President, Clinical Operations. The position reports to Senior Vice President, Clinical Development. The location of the position is in Brisbane, CA.
The Vice President, Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical programs and the management of staff responsible for multiple therapeutic areas and projects. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties & Responsibilities
- Oversight, management and guidance of Ph 1 – Ph III clinical programs for Myovant to ensure quality, timeline and budget goals are met
- Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas within; Interact and collaborate with other department heads as appropriate.
- May present Clinical Operation updates to the executive team
- Responsible for the strategic resource management of in-source/out-source study requirements
- Evaluate and select service providers and manage these resources effectively
- Manage and lead a team of 10+ employees
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- Experience managing a rapidly changing organization and integrating new personnel is essential, as well as, ability to evaluate and resolve complex problems
- Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical affairs trials, clinical study design, and data management methods.
- Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
- Experience with global drug development
- 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
- Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
- Proven experience handling confidential and 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.\
- Daily demonstrates a positive, ‘can do’ and service oriented attitude.
- Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Travel as required by business needs
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferable
- Ten or more years of clinical trial experience at a pharmaceutical, biotechnology or CRO Company plus 8 years of experience in significant management role
- Ability to effectively manage multiple projects concurrently
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
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.
Equal Employment Opportunity