Scientific Director, Oncology Early Development

Company Description

About AbbVie

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.

Job Description

Purpose:

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

Responsibilities: 

• Manages the design and implementation of one or more clinical development programs in support of an 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.
• Has overall responsibility for oversight of 1-2 clinical studies, monitoring overall study integrity and responsibility for data review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.  Overall responsibility for data review / medical monitoring to ensure quality data for both in-house and outsourced studies.
• Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
• May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs; provide oversight of Contract Research Organization (CRO) and other vendors on the trials
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Will serve on an Asset Study Team (AST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• 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 the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
• Ability to provide input and direction to clinical research with appropriate supervision.
• At least 5+ years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to oversee a clinical research program of moderate complexity with minimal supervision.
• Ability to perform and bring out the best in others on a cross-functional global team.
• Ability to intera