Senior Scientific Director, Neuroscience Clinical Development - Psychiatry

About the role

The Senior Scientific Director, Neuroscience Clinical Development - Psychiatry leads the direction, planning, and interpretation of clinical trials or research activities of one or more clinical development programs. They participate in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, 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, study site personnel and AbbVie study staff.
• Makes decisions regarding the design, 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 one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial 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 and protocols 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. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Requirements

• Bachelor's 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
• Excellent oral and written English communication skills
• Ability to exercise judgment and address complex problems and create solutions for one or more projects

Qualifications

• Must possess excellent oral and written English communication skills
• Must be able to exercise judgment and address complex problems and create solutions for one or more projects

Skills

• Strong medical and scientific principles
• Knowledge of compliance and regulatory requirements
• Experience in development of clinical strategy and the design of study protocols
• Ability to interact externally and internally to support a global scientific and business strategy
• Extensive knowledge of clinical trial methodology
• 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

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k)
• This job is eligible to participate in our long-term incentive programs

Pay

$206,500 - $393,000 USD

Schedule

Hybrid