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About the Role

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting the overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of study protocols for a clinical development 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.
• Reviews, interprets, and communicates accumulating data pertaining to the safety and efficacy of the molecule.
• Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables.
• Contributes to 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 contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
• Participates in 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.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
• Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
• May contribute to regulatory responses and discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in conducting research.

Requirements

• Ability to provide input and direction to clinical research with appropriate supervision.
• Strong desire to collaborate in a cross-functional setting.
• Ability to interact externally and internally to support global scientific and business strategy.
• Must possess excellent oral and written English communication skills.

Skills

• Clinical trial methodology
• Regulatory and compliance requirements governing clinical trials
• Design of study protocols

Experience Level

• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.

Education Level

• Bachelors degree in the sciences
• Advanced degree (e.g., MS, PhD) preferred.

Salary/Compensations

• USD 160500 - USD 305000 - yearly

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Eligible to participate in our long-term incentive programs.

About the Company

• AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
• We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Equal Opportunity

• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
• Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html