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 Associate Director/Director, Clinical Development. The position will report to the Vice President, Clinical Development – Women’s Health. The location of the position is in Brisbane, CA; remote location will be considered.
The Associate Director/Director, Clinical Development, as clinical lead, will be responsible for the advancement of late stage clinical development program for our women’s health programs in uterine fibroids and endometriosis.
Essential Duties and Responsibilities
- Demonstrated scientific and clinical expertise in Women’s Health Therapeutic Area, and provide clinical insight into the drug development strategy
- Translate commercial input into clinical development strategy
- Provide scientific/medical input into study design, execution, data analysis, and interpretation that is aligned with the strategic direction of the program
- Review literature to support the Women’s Health Platform Team and initiate database analyses to support objectives
- Review/author protocols, clinical study reports, publications, and regulatory submissions and provide clinical input
- Lead the cross functional teams (including, but not limited to, clinical operations, safety, regulatory, early clinical development and biostatistics) in the management and execution of clinical studies
- Work with clinical operations, safety, assigned Clinical Research Organizations, and study vendors to assure the execution of clinical trials, consistent with GCP guidelines
- Serve as the medical monitor of clinical studies.
- Identify and manage external collaborators and key investigators
- Assess project/program needs and resources and address in a timely fashion to maintain program timelines and deliverables
- Ensure adherence to agreed-upon timelines/budgets, while maintaining regulatory compliance
- Provide scientific/medical input for key scientific meetings and present key data
- Participate in and provide clinical input into regulatory interactions
- Identify new clinical research opportunities and enhance Myovant’s scientific medical knowledge and capabilities
- Support product lifecycle management
- Contribute to the Long-Range Planning
Core Competencies, Knowledge, and Skill Requirements
- Excellent interpersonal skills and ability to develop strong relationships with stakeholders
- 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
- Ability to think analytically and strategically to formulate, develop, and execute clinical plans
- Demonstrated ability to review, interpret and present complex scientific data
- M.D. or DO required with a minimum of 2 years of pharmaceutical industry drug development experience
- Obstetrics/Gynecology training preferred; internal medicine, endocrinology backgrounds welcomed
- Travel commitment of 25%
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