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 Director/Senior 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 Director/Senior 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. The individual must have the ability to work independently and also as an effective and engaged member of a cross-functional team in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties and Responsibilities
- Demonstrating scientific and clinical expertise in Women’s Health Therapeutic Area, and providing clinical insight into the drug development strategy
- Translating commercial input into clinical development strategy
- Providing 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.
- Identifying and managing 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
- Participating in and providing clinical input into regulatory interactions
- Identifying new clinical research opportunities and enhancing Myovant’s scientific medical knowledge and capabilities
- Perform due diligence for in-licensing proposals and support partner relations
- Support product lifecycle management
- Contribute to the Long-Range Planning
- May mentor, coach, and oversee the performance of direct reports
Core Competencies, Knowledge, and Skill Requirements
- Requisite skill set to carry-out above noted “essential duties and responsibilities”
- Ability to think analytically and strategically to formulate, develop, and execute clinical plans
- Strong leadership skills with an ability to set vision, lead change, and mentor others
- Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
- Demonstrated ability to review, interpret and present complex scientific data
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, honesty, integrity, and trust building behaviors
- High degree of professionalism and ability to work with limited direction
- 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.
- Skilled in developing collaborative internal and external relationships
- Required skill in the operation of standard office equipment including printer/scanners, copy machines and other equipment as necessary
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Excellent verbal and written communication skills, as the position will interface scientific experts and internal staff
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- MD or DO required
- Obstetrics/Gynecology training preferred; internal medicine, endocrinology backgrounds welcomed.
- Minimum of 5 years of pharmaceutical industry drug development experience
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
- Travel commitment of 25-40%
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