Executive Medical Director, 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.

The Executive Medical Director, Clinical Development will lead clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding of compliance and regulatory requirements as well as awareness across business operations, and emerging issues.

Roles and Responsibilities of the Position:

• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• May participate in or lead clinical development contributions for due diligence or other business development activity. As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with cross functional teams as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Lilly at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Basic Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in Oncology or Hematology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification.
• Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
• Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC

Additional Preferences:

• 3+ years Clinical Trials/Research experience in pharmaceutical industry, academia, or research setting.
• PhD is highly preferred.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint, and Excel.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizati