VP of Clinical Development

We are looking for VP of Clinical Development who will be 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.

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
• 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 the Women’s Health platform and its current and future product portfolio to registration and approval.
• Establish and manage effective relationships with scientific leaders and
• 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 / SKILL REQUIREMENTS

• 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
• Successful NDA/MAA experience and oversight of clinical activities and
• 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
• 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
• 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
• Strong judgment and decision-making skills in making critical go/no-go
• An energetic entrepreneurial planner and builder rather than a “steady state manager;”
• Unquestionable integrity and highest ethical
• 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
• Knowledge and understanding of clinical trials and regulatory
• Ability to professionally communicate and cultivate strong working
• Ability to collaborate effectively with peers in cross-functional team

EDUCATIONAL REQUIREMENT

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

Job Type: Full-time

Schedule:

• 8 hour shift

Work Location: In person