Director, Clinical Pharmacology

BioSpace; North Chicago (IL); Presencial; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical/dental/vision insurance

401(k) plan

Paid time off

Descripción de la vacante

AbbVie in the United States is seeking a senior Clinical Pharmacology leader to communicate pharmacology strategy to senior management, regulators, and external peers. You will guide PK/PD development, contribute to drug development strategy, and lead teams across projects, ensuring alignment with regulatory expectations and business goals.

Responsibilities include directing PK/PD activities, providing scientific consultation to R&D and Regulatory, and mentoring staff while driving process

Formación

• PhD or PharmD with extensive PK/PD experience preferred.
• MS with 15+ years relevant experience also acceptable.
• BS with 17+ years related experience may be considered.

Responsabilidades

• Leads Clinical Pharmacology/PK/PD activities and major projects.
• Assists R&D senior management in action plan selection.
• Identifies issues and conducts risk assessments.
• Provides timelines and negotiates deliverables with functions.
• Writes regulatory documents and responses for filings.
• Conducts due diligence and represents CLINICAL PHARMACOLOGY in BD teams.
• Develops process improvements and aligns with management.
• Contributes to departmental goals and PK/PD decisions.
• Maintains up-to-date PK/PD data analysis knowledge.
• May manage personnel within the team.

Conocimientos

Leadership in PK/PD

Drug development knowledge

Regulatory strategy

Clinical pharmacology

Project management

Cross-functional collaboration

Scientific communication

Educación

PhD or PharmD with extensive experience

MS with 15+ years experience

BS with 17+ years experience

Descripción del empleo

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

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 help 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

Qualifications

PhD with typically 7+ years of experience or Pharm D with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)

Excellent interpersonal skills

Knowledge and experience in multiple therapeutic and/or functional areas

Experience across range of development phases

Knowledge of AbbVie and Pharma drug development processes

Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects

Scientific project leadership or related experience

Project management skills such as scope management, progress tracking/driving as well as time management

Participates in initiatives and advancement of CLINICAL PHARMACOLOGY

Key Leadership Competencies

• Knows the business and the cross-functional contributions needed to deliver results
• Persistent and resilient finds the way to move good ideas forward
• Acts respectfully yet courageously
• Connects unrelated concepts, generates original or unique ideas
• Influences colleagues to achieve cross-functional alignment
• Communicates openly and honestly with all colleagues
• Manages conflict and difficult conversations in a constructive transparent way Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. 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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html