Director, Clinical Pharmacology (Oncology)

ICompany Description

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, and Tik Tok.

Job Description

Purpose

Communicates / presents key Clinical Pharmacology information / strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments / divisions for any study / project needs. Understands linkages across businesses and understands the impact of business decisions and solutions. May lead teams within Clinical Pharmacology and Pharmacometrics and accountable for effective performance of the teams.

Responsibilities

• Leads Clinical Pharmacology / PK / PD activities and multiple major projects. Assists R&D senior management in the selection of action plans that best meets drug development business objectives.
• Identifies issues and helps with issue resolution. Conducts risk assessments and assists in development of contingency plans. Assures project remains in alignment with strategic objectives.
• Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality / performance).
• Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
• Responsible for evaluating technical, scientific aspects of all AbbVie projects along with CLINICAL PHARMACOLOGY management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response to Regulatory agency comments.
• Independently conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
• Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
• Contribute to development of departmental goals. Influences strategic PK / PD decisions for the department.
• Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK / PD data analysis, modeling and simulation methods and software.
• May manage personnel including development, mentoring, and effective delegation.

Qualifications

Knows the business and the cross‑functional contributions needed to deliver results

This is a hybrid opportunity that requires to be onsite 3x / week

Additional Information

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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