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
Write and/or review content for protocol training, site initiation visits, and investigator/study coordinator meetings, clinical presentation slides, scientific meetings, conferences, other events and presentations, and contribute to scientific publication of study results as needed
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
Lead clinical data analysis and interpretation to support regulatory submissions, scientific publications, and presentations
Prepare and review abstracts, posters, and manuscripts for scientific conferences and publications

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
Proven experience in designing, managing, and executing clinical trials, from early-stage development through late-stage clinical studies
Gene therapy and/or ophthalmology (retina) experience preferred
Strong understanding of gene therapy, rare diseases, and genetic disorders
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

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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Associate Director – Clinical Affairs

Key skills