Scientific Director, Oncology Clinical Development - Lung
AbbVie
9 hours ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan; oversees project-related education of investigators, study site personnel and AbbVie study staff.
- Reviews, interprets, and communicates accumulating data pertaining to safety and efficacy; may oversee study enrollment and overall timelines for key deliverables (with Clinical Operations).
- Contributes to 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 development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with matrix team members.
- Participates in opinion leader interactions; partners with Medical Affairs, Commercial and other functions as required.
- Stays abreast of professional information and technology through conferences, medical literature and training.
- Understands and complies with regulatory requirements related to clinical studies and global drug development; may contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards.
Qualifications:
- Bachelor’s degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
- 3+ years of clinical trial experience in the pharmaceutical industry or academia (or equivalent) preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in designing study protocols desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.
Responsibilities:
- With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan; oversees project-related education of investigators, study site personnel and AbbVie study staff.
- Reviews, interprets, and communicates accumulating data pertaining to safety and efficacy; may oversee study enrollment and overall timelines for key deliverables (with Clinical Operations).
- Contributes to 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 development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with matrix team members.
- Participates in opinion leader interactions; partners with Medical Affairs, Commercial and other functions as required.
- Stays abreast of professional information and technology through conferences, medical literature and training.
- Understands and complies with regulatory requirements related to clinical studies and global drug development; may contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards.
Qualifications:
- Bachelor’s degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
- 3+ years of clinical trial experience in the pharmaceutical industry or academia (or equivalent) preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in designing study protocols desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.