Purpose:

Leads the direction, planning, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities:

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the 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.
• Provides leadership of the OED Clinical Sciences team and champions clinical research excellence through innovation initiatives and process improvement.
• Lead, mentor and develop a high performing Clinical Science function, including resource allocation, talent development and succession planning to champion clinical research excellence through innovation initiatives and process improvement.
• Oversee portfolio-level management to ensure consistency, quality, and scientific rigor across all clinical deliverables and development programs.
• Build and own the standards, tools, and best practices that ensure clinical relevance, scientific integrity, and high-quality data interpretation across programs.
• Primary responsibility for and ownership of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents. Drive the delivery of clinical strategy for the early-phase pipeline, ensuring alignment with translational insights, regulatory expectations, and commercial considerations.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• May serve on or co-chair Integrated Evidence Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Co Chair, responsibilities may include supervision of matrix team members & serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) & ADT Leadership Boards (ALBs).
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. Prior expertise in the areas of CART therapies and  Antibody Drug Conjugates may be an advantage. May participate in or lead clinical development contributions to 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.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with cross functional teams (ie. Clinical Development, Clinical Operations, Biometrics, Regulatory) to define cross‑functional ways of working and ensure effective program resourcing
• Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
• 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.