Senior Scientific Director, Clinical Development - Consumer Eye Care Product Development

Role Summary

Senior Scientific Director, Clinical Development - Consumer Eye Care Product Development. Leads cross-functional collaborations on identifying and developing consumer eyecare products (artificial tears, gels and ointments) and directs, plans, and interprets clinical trials or research activities within consumer eye care innovation for one or more programs.

Responsibilities

• Serves as an in-house expert in identification and development of consumer eye care products; contributes to translational strategies and may participate in due diligence or business development activities.
• Champions innovation in consumer eye care; coordinates with Medical Affairs, Commercial and other functions to incorporate broad cross-functional perspectives into Clinical Development Plans and protocols.
• Leads design and implementation of multiple clinical development programs (or a large, complex program) aligned with the product development plan; oversees education of investigators, site personnel and study staff.
• May lead clinical study teams; monitors study integrity and communicates data on safety and efficacy; ensures enrollment and timelines for key deliverables.
• Owns design, analysis, interpretation and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and related documents.
• Oversees work of Medical/Scientific Directors and Clinical Scientists on related programs.
• May serve on Integrated Evidence Strategy Teams; helps develop a cross-functionally aligned Clinical Development Plan; may supervise matrix team members.
• Stays current with professional information and may represent AbbVie at external meetings.
• Understanding regulatory requirements for clinical studies and global drug development; acts as clinical representative in regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and other quality standards.

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, OD, MD, PharmD) preferred.
• At least 8 years of product development experience with 5 years in consumer eye care in pharma, academia, or equivalent.
• Direct experience leading cross-functional and translational development preferred.
• Ability to run a complex clinical research program independently.
• Proven leadership and ability to lead through influence on a global cross-functional team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements; experience in clinical strategy and study protocol design.
• Excellent oral and written English communication skills.
• Ability to address complex problems and create solutions for multiple projects.