Senior Scientific Director, Eye Care Clinical Development

Role Summary

Leads the direction, planning, and interpretation of clinical trials or research activities for one or more eye care clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting the product's scientific and business strategy.

Responsibilities

• Leads and demonstrates ownership of the interpretation and internal/external data dissemination of multiple clinical development and exploratory programs in eye care development, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, site personnel and AbbVie study staff.
• Leads all medical writing and scientific communications at the AbbVie Eye Care Research Center including, but not limited to protocols, procedure manuals, regulatory/ethics committee submissions, clinical study reports, memos, abstracts, and manuscripts.
• Has responsibility for leading data interpretation, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Primary responsibility for and ownership of, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• Serves as an in-house clinical expert for internal and external scientific communications, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
• Leads clinical interpretation and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans, protocols, and publications 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 AbbVie 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.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred
• At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
• Ability to run a complex clinical research program independently
• 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
• Ability to interact externally and internally to support a global scientific and business strategy
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
• Must possess excellent oral and written English communication skills
• Ability to exercise judgment and address complex problems and create solutions for one or more projects