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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

• With supervision, manages the design and implementation of first-in-human (Phase 1) study protocols for a clinical development program.
• Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
• Reviews, interprets, and communicates accumulating data pertaining to 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 for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
• May contribute to the development of a rigorous, cross-functionally-aligned Clinical Development Plan.
• Participates in opinion leader interactions related to the disease area(s) and partners with other functions.
• Stays abreast of professional information and technology to augment expertise in the therapeutic area.
• Responsible for understanding and complying with regulatory requirements for clinical studies and global drug development.
• 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.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is required.
• Ability to interact externally and internally to support global scientific and business strategy.
• Must possess excellent oral and English communication skills.

Skills

• Medical and scientific principles
• Knowledge of compliance and regulatory requirements
• Understanding of AbbVie’s customers, markets, business operations, and emerging issues
• Clinical trial methodology
• Regulatory and compliance requirements governing clinical trials
• Design of study protocols

Experience Level

• Workday Global Grade: 20

Education Level

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) required.

Salary/Compensations

• USD 141500 - USD 268500 - yearly

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Eligible to participate in 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