Scientific Director, Oncology Clinical Development (Solid Tumors)

Purpose:
- With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program; generates, delivers and interprets high-quality clinical data supporting product strategy.

Responsibilities:
- Manages design and implementation of study protocols for a clinical development program (with supervision) in support of the Product Development Plan; oversees project-related education for investigators, study site personnel, and AbbVie study staff.
- Reviews, interprets, and communicates accumulating safety and efficacy data; with Clinical Operations, may oversee study enrollment and key deliverable timelines.
- Contributes to design, analysis, interpretation and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other documents.
- May contribute to development of a rigorous, cross-functionally-aligned Clinical Development Plan.
- Participates in opinion leader interactions; partners with Medical Affairs, Commercial, and other functions per corporate policies.
- Stays current via conferences, medical literature, and training.
- Ensures understanding of and compliance with regulatory requirements for clinical studies/global drug development; may contribute to regulatory responses.
- Ensures adherence to GCP, pharmacovigilance standards, SOPs, and other quality standards.

Qualifications:
- Bachelor’s degree in the sciences; advanced degree (MS/PhD) preferred.
- Ability to provide input/direction to clinical research with appropriate supervision.
- Strong cross-functional collaboration.
- Clinical trial experience in pharma/academia (preferred).
- Knowledge of clinical trial methodology, regulatory/compliance requirements; protocol design experience (desirable).
- Ability to interact externally/internally to support global strategy.
- Excellent oral and written English communication.