Associate Director - Clinical Affairs

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 Director of Clinical Affairs will play a pivotal role in the clinical development of gene therapy programs, overseeing strategic planning, execution, and management of clinical trials. This position will ensure that clinical studies are conducted in compliance with regulatory requirements, scientific standards, and company goals. The Director will be responsible for cross-functional collaboration with internal teams, key opinion leaders, clinical investigators, and regulatory agencies.

Key Responsibilities:

Clinical Strategy, Planning, and Execution:

• Collaborate with Clinical Operations, Clinical Development, and Medical Affairs to ensure clinical trials align with the company's overall strategic goals.
• Provide scientific and clinical leadership in the design and execution of protocols and clinical development plans.
• Collaborate with Clinical Development to review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses to support interactions with US and Global Health Authorities
• Writes and/or reviews content for protocol training, site initiation visits, and investigator/study coordinator meetings, clinical presentation slides, scientific meetings, conferences, other events and presentations, and contributes to scientific publication of study results as needed

Regulatory and Compliance:

• Collaborate with clinical team to ensure timely submissions of Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and other regulatory documents.
• Ensure compliance with global clinical trial regulations and guidelines, including ICH, GCP, and relevant health authorities.

Data Management and Reporting:

• Lead clinical data analysis and interpretation to support regulatory submissions, scientific publications, and presentations.
• Ensure that clinical study reports, clinical development summaries, and other key documents are prepared accurately and on time.
• Participate in the preparation and review of abstracts, posters, and manuscripts for scientific conferences and publications.

Qualifications:

• Advanced degree in life sciences (PhD, PharmD) or related STEM field.
• 5+ years of relevant experience in clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) 
• Proven experience in designing, managing, and executing clinical trials, from early-stage development through late-stage clinical studies.

Qualifications:

• Gene therapy and/or ophthalmology (retina) experience preferred.
• Strong understanding of gene therapy, rare diseases, and genetic disorders.
• Proven experience in designing, managing, and executing clinical trials, from early-stage development through late-stage clinical studies.
• In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP) and global clinical trial regulations.
• Excellent leadership and communication skills, with the ability to work effectively across teams and influence key stakeholders.
• Strong analytical, problem-solving, and decision-making abilities.
• Experience in rare diseases or orphan drug development.
• Strong relationships with key opinion leaders in the field of gene therapy and rare diseases.
• Prior experience with IND and BLA/NDA submissions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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