Vice President, Clinical Regulatory Affairs

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 leader for the position of Vice President, Clinical Regulatory Affairs who will provide regulatory strategic and operational leadership to advance the development and approval of Myovant's pipeline. The individual will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other regulatory interactions, as well as international submissions. This position reports to the Senior Vice President, Regulatory Affairs and Quality Assurance. The location is based in Brisbane, CA and can be flexible for the right candidate.

Essential Duties and Responsibilities

• Responsible for the development of global regulatory strategies for all programs and plans for execution in conjunction with leads from other functional areas and project teams.
• Provide regulatory guidance and strategy to the regulatory function, project teams and governance bodies including identifying and assessing regulatory risks for non-clinical, clinical and commercial development plans and activities.
• Set strategy and required content of scientifically sound, accurate and complete nonclinical and clinical submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.).
• Interact with and key point of contact for regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
• Effectively oversee the planning, organization, preparation and conduct of formal meetings with regulatory agencies in close collaboration with functional subject matter experts including the preparation and submission of meeting requests and briefing documents.
• Oversee the creation, updating, and maintenance of the core data sheet and local labelling records throughout product lifecycle ensuring compliance with regulatory authority requirements.
• Monitor changes in the regulatory environment; Interpret and analyze regulatory legislation, guidance and precedent as well as external developments to provide direction to internal stakeholders, especially on regulatory matters that may affect ongoing development programs.
• Work with project teams and joint development committees to resolve complex project issues.
• Support development and presentation of development/regulatory strategies to governance bodies.
• Assure compliance with project team timelines and milestones. Provide organizational support and be prepared to hire and manage new personnel (including contingent workers) as company grows its product development pipeline.
• Ensure and contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
• Provide leadership and direction to clinical regulatory group. Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals.
• Other projects when assigned.

Core Competencies

• Demonstrate communication and collaboration skills with an ability to effectively manage and influence stakeholders in a matrix environment
• 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
• Demonstrate coaching skill to inspire, develop, and motivate team
• 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.

REQUIREMENTS (Education and Experience)

• Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
• Advanced degree MD, PharmD, or PhD preferred along with 20 years of biopharmaceutical experience, which include at least 15 years of direct experience in Regulatory Affairs
• Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs)
• Demonstrated leadership skill leading a functional team
• Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional)
• Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision.

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 careers@myovant.com.

Equal Employment Opportunity