Vice President, Clinical Development - Women's Health

Location
Brisbane, CA, United States
Posted
Mar 31, 2021
Ref
4986877002
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
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 Development - Women's Health. The position reports to the Senior Vice President, Clinical Development.

Summary Description

The Vice President, Clinical Development fulfills a critical and highly visible role to help shape the future of development in Women's Health at Myovant. (S)he is responsible for the successful strategic positioning and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs and Commercial functions.

The Vice President, Clinical Development position reports to the Senior Vice President, Clinical Development, has functional responsibility for all clinical development activities in Women's Health, including Phase 2 and 3 programs, approval, and Phase 4 programs. (S)he is responsible for developing strategic and resource plans for these programs to ensure they meet quality, efficacy and safety standards required by medical and regulatory agencies. Additionally, as the Clinical Development Lead in the Women's Health Project Team, the Vice President, Clinical Development provides strategic and clinical direction to this cross-functional team from preclinical experiments to the end of the product's life cycle. The Vice President, Clinical Development is an active member of the Development Leadership Team.

The Vice President, Clinical Development will lead a world-class group focused on Women's Health and will actively participate in strategic planning and partnering discussions. (S)he also is expected to cultivate relationships with scientific leaders and serve as an outward-facing representative of the company to the scientific community.

Essential Duties & Responsibilities
  • Responsible for clinical development strategy and clinical development plans for Women's Health programs and accountable to deliver on their corporate objectives and agreed upon milestones.
  • Responsible to develop and execute corporate clinical strategy for global development projects in Women's Health.
  • Oversee, plan, and manage the budget for Women Health clinical development activities.
  • Provide leadership and clinical expertise to the overall development organization including the clinical development, clinical operations, biometrics, clinical pharmacology, and non-clinical teams.
  • Establish and maintain effective communication and collaboration with other leaders across the organization.
  • Provide medical vision and clinical leadership for the strategy and plan to advance Myovant's Women's Health platform and its current and future product portfolio to registration and approval.
  • Establish and manage effective relationships with scientific leaders and investigators.
  • Provide critical and clinical input to regulatory issues and serve as key interface with regulatory agencies.
  • Build, manage, and mentor an effective, top-notch clinical development team to successfully execute clinical programs.
  • Contribute to delineation of applicable unmet medical needs, competitive landscape, and desirable target product profiles.
  • Maintain understanding of competitors and clinical development in relevant areas of Women's Health by attending scientific meetings and tracking literature.
  • Provide day-to-day practical and overarching strategic guidance for Women's Health clinical programs, ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information that allows for clear decision making and advancement of development efforts.
  • Work closely with the business, medical affairs, commercial and regulatory functions to strategize drug development paths that seek to deliver timely regulatory approvals in areas of defined commercial merit.

Core Competencies, Knowledge and Skill Requirements

The Vice President, Clinical Development must have extensive senior-level experience in development of pre-clinical and clinical candidates, ideally with experience in Women's Health, although specific therapeutic area expertise is not a requirement. This person will have a thorough understanding of all the requirements and processes needed to take a potential drug through development and ultimately registration.

The ideal candidate will possess the following experience and qualifications, including the particularly important skills of logical thinking, ability to prioritize and problem solve, a "can-do" attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.
  • Strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of mid-to-late stage therapeutic programs. A record of accomplishment including developing, planning, and designing clinical studies ideally leading to the successful registration of therapeutics.
  • Significant experience with global clinical trials and regulatory process.
  • Successful NDA/MAA experience and oversight of clinical activities and pharmacovigilance.
  • Successful track record of interactions with regulatory agencies (FDA, EMA and MHRA).
  • Credibility within the global medical and scientific community. Ability to forge solid personal and professional relationships with key opinion leaders is desired.
  • Experience presenting to a wide variety of audiences including internal teams, Board of Directors, investors, medical and scientific communities.
  • Solid management skills and a good reputation for managing others to succeed.
  • Hands-on style with proven ability to work in an entrepreneurial environment and ability to manage and outsource work as required.
  • Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.
  • Demonstrated ability to lead and scale multi-disciplinary teams.
  • Strong judgment and decision-making skills in making critical go/no-go decisions.
  • An energetic entrepreneurial planner and builder rather than a "steady state manager;"
  • Unquestionable integrity and highest ethical standards.
  • Effective at identifying and engaging scientific, medical, and regulatory experts to identify value-creating options, and to refine and implement plans.
  • Effective at synthesizing the scientific and medical literature to make informed decisions and determine best development pathways.
  • Track record of success in supporting business development activities and working effectively in corporate partnerships.
  • Proven track record of excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders, develop strong positive relationship with senior management and provide leadership and guidance to high functioning clinical and regulatory teams.
  • Strong external presence with excellent written and verbal communication skills; and
  • Self-motivated, assertive, and driven.
  • Knowledge and understanding of clinical trials and regulatory requirements.
  • Ability to professionally communicate and cultivate strong working relationships.
  • Ability to collaborate effectively with peers in cross-functional team settings.

REQUIREMENTS

Education

  • MD is required.
  • Board Certified in Obstetrics and Gynecology (preferred), or Internal Medicine

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