Phase 1 Clinical Development Director

AbbVie; California (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical Development professional to oversee direction, planning, execution and interpretation of clinical trials within a cross-functional team. You will contribute to protocol design, safety and efficacy interpretation, and regulatory submissions to support product strategy.

With a scientific background and experience in Phase 1 or related trials, you will collaborate across Medical Affairs, Discovery and Commercial groups while ensuring compliance with Good Clinical

Qualifications

• Bachelor's degree in the sciences; advanced degree (MS/PhD) required.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is required.
• Must possess excellent oral and written English communication skills.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.

Responsibilities

• Design and implement first-in-human Phase 1 study protocols for a clinical development program under supervision.
• Review, interpret, and communicate accumulating data on safety and efficacy of the molecule.
• Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses.
• Contribute to the development of a rigorous, cross-functionally-aligned Clinical Development Plan in collaboration with matrix team members.
• Participates in investigator interactions and collaborates with Medical Affairs, Discovery, and other functions.
• Stays abreast of professional information through conferences and literature to augment expertise in the therapeutic area.

Skills

English communication

Cross-functional collaboration

Education

Bachelor's degree in sciences

Advanced degree (MS, PhD)

Job description

AbbVie is seeking a Clinical Development professional to oversee direction, planning, execution and interpretation of clinical trials within a cross-functional team. You will contribute to protocol design, safety and efficacy interpretation, and regulatory submissions to support product strategy.

With a scientific background and experience in Phase 1 or related trials, you will collaborate across Medical Affairs, Discovery and Commercial groups while ensuring compliance with Good Clinical