Associate Vice President - Women’s Health & Early Clinical Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Summary:

The Associate Vice President (AVP), Women’s Health & Early Clinical Development, serves as a pivotal leader responsible for establishing and advancing Lilly's Women's Health portfolio. We are looking for a dynamic and strategic leader with deep understanding of women’s health physiology, pathophysiology and clinical care, and a passion for developing new medicines to advance women’s health. The ideal candidate will have a track record of impactful translational and/or clinical research related to women’s health, and a demonstrated ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing research and clinical development programs through Phase 2, liaising with drug discovery scientists, external innovation, late phase development and commercial colleagues to evaluate and progress new therapeutic opportunities, and advancing external collaborations and strategic partnerships to drive impactful outcomes for women’s health. The AVP will shape and execute strategies for both internal and external portfolio growth, and will collaborate closely with enterprise leaders to align scientific research and development with overarching company objectives.

We are seeking a candidate with an MD or MD/PhD in gynecology or reproductive endocrinology, who specializes in the health of the female reproductive system and has provided comprehensive care for conditions including menstrual disorders, preeclampsia, infertility, menopause, and osteoporosis. Experience as a clinical researcher in academia or expertise in pharmaceutical drug development is essential.

Position Responsibilities:

Portfolio Strategy and Clinical Planning

• Shape Lilly’s strategy in Women’s Health by combining a deep understanding of current therapeutic landscape and competitive environment with evaluation of internal and external opportunities to build an industry-leading portfolio.
• Develop project concepts, investment strategies and clinical development plans that that allow for efficient assessment of new therapeutic approaches and targets
• Collaborate with new product planning to develop and maintain Draft Launch Labels and Value Propositions that address key customer needs
• Contribute to and lead innovative drug discovery and development projects
• Serve as medical expert in interactions with external partners and during assessment of business development opportunities

Clinical Research, Trial Execution and Support

• Collaborate with clinical research staff in design, conduct and reporting of clinical trials
• Review and approve risk profiles to ensure appropriate communication to study subjects
• Assist in planning and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Participate in investigator identification and selection
• Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct consistent with Good Clinical Practices and local laws and requirements.
• Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events
• Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards.

Regulatory Support Activities

• Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective. Provide medical expertise to regulatory scientists.

• Participate in face-to-face meetings with FDA, EMEA and other regula