Sr. Director - Clinical Development

Role Summary

Sr. Director - Clinical Development role focusing on Immunology gastroenterology within late-phase and marketed programs. Leads development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization; oversees global clinical trial implementation, safety reporting, protocol and data dissemination review, and regulatory interactions. Serves as a scientific resource ensuring compliance with GCP, regulatory requirements, and Lilly policies while guiding medical strategy and activities to support product demand realization.

Responsibilities

• Clinical Planning: Collaborate across regions and functions to develop and maintain launch labels, value propositions, lifecycle plans, clinical strategies, development plans, and study protocol designs; align clinical strategy globally.
• Clinical Research/Trial Execution and Support: Plan and review scientific content of protocols, informed consent documents, final study reports, and submissions; provide oversight of protocols and informed consent; design, conduct, and report local clinical trials; ensure risk communication and regulatory/ethical requirements are met; train investigators and site personnel; support safety monitoring and adverse event follow-up.
• Scientific Data Dissemination/Exchange: Ensure compliance with data dissemination guidelines; support external communications with healthcare professionals; plan symposia and meetings; prepare and review medical information materials and publications; facilitate collaborations with experts and societies; support training and congress activities.
• Regulatory Support Activities: Develop and review label changes; provide medical expertise to regulatory scientists; assist in regulatory submissions and regulatory issue resolution; participate in advisory committees and risk management planning.
• Business/Customer Support (Pre- and Post-Launch): Develop medical strategies to support brand commercialization; address scientific information needs of customers; lead data analyses and outcomes research; collaborate with marketing and external experts; contribute to development of payer partnerships and product value.
• Scientific/Technical Expertise and Continued Development: Critically evaluate medical literature; stay current on trends; provide scientific training to study teams; act as protocol expert and scientific consultant; pursue extramural scientific opportunities; attend scientific symposia.
• General Responsibilities: Support budget preparation/administration; pursue professional development; participate in recruitment and diversity efforts; collaborate with alliance, business, and vendor partners; provide leadership and mentoring; ensure ongoing qualification and training; be an ambassador for patients and the Lilly Brand.

Qualifications

• Minimum Qualification Requirements:
  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in the appropriate specialty/subspecialty 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 LCME requirements.
• Preferred Qualifications:
  • Demonstrated ability to balance scientific priorities with business priorities; examples of successful leadership.
  • Strong communication, interpersonal, teamwork, organizational, and negotiation skills.
  • Ability to influence cross-functional colleagues to create a positive working environment.
  • Willingness to travel domestically and internationally as needed to support the business.
  • Fluent in English, both verbal and written.

Education

• Medical Doctor or Doctor of Osteopathy degree required; board eligibility/certification in an appropriate specialty/subspecialty.

Additional Requirements

• Travel (domestic and international) to the degree appropriate to support the business of the team (as identified in Preferred Qualifications).