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 reports to Senior Vice President, Clinical Development. The location of the position is in Brisbane, CA.
The Director/Senior Director, Clinical Development, as clinical lead, will be responsible for the advancement of multiple late stage clinical development programs (CDPs) for our women’s health programs. 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
- Assist in the design of strategic clinical development programs (CDPs)
- Develop clinical protocols that align with the CDP and that meet ethical and regulatory standards
- Lead the cross functional teams (including, but not limited to, clinical operations, safety, regulatory, PK and statistics) in the management and execution of the strategic CDP
- Work with clinical operations, safety, assigned CROs and study vendors to assure the execution of clinical trials, consistent with GCP guidelines
- Serve as medical monitor of clinical studies
- Manage and develop other medical directors
- Review, summarize and present clinical data at key meetings across various venues
- Draft and/or edit clinical study reports, update investigator brochures and other required annual updates to regulatory documents (US and exUS)
- Assist in the development of INDs as appropriate
- Participate in and prep for strategic interactions with regulatory agencies (US and exUS)
- Establish and maintain key working relationships with clinical trial investigators, expert leaders in the field (e.g., KOLs, academicians, etc.) as per ethical guidelines
- 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
- Participate in due diligence activities for other potential BD opportunities from a clinical perspective
- Perform other duties as assigned
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 in all dealings is essential and required
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
- 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.
- Skilled in developing collaborative internal and external relationships
- 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)
- 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
- MD or equivalent required
- Oncology training preferred
- 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.
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Equal Employment Opportunity