Director, Clinical Pharmacology

BioSpace; North Chicago (IL); Hybrid; USD 170.000 - 260.000; Vollzeit

Benefits dieser Stelle

Benefits package

Paid time off

401(k) program

Incentive programs

Zusammenfassung

AbbVie is seeking a senior leader to head Clinical Pharmacology/Pharmacometrics efforts in a hybrid Lake County, IL setup. You will guide PK/PD strategy, coordinate across R&D and Regulatory, and drive important drug development projects to meet business objectives.

The role requires a PhD or PharmD with extensive experience in pharmacometrics and drug development, with strong leadership and cross-functional collaboration skills. Competitive benefits and incentive programs are available.

Qualifikationen

• PhD with typically 9+ years of experience or PharmD with typically 11+ years of experience in a relevant field.
• Master's in Science or related field with 17+ years of related work.
• Bachelor's in Science or related field with 19+ years or more of related work.

Aufgaben

• Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects.
• Provides expert scientific and strategic consultation to R&D, Regulatory, and management.
• Reviews clinical protocols and regulatory documents for filings and responses to agency comments.
• Leads development of departmental goals and strategic PK/PD decisions.
• Manages personnel development, mentoring, and cross-functional team leadership.

Kenntnisse

Clinical Pharmacology

PK/PD

Pharmacometrics

Leadership

Regulatory liaison

Ausbildung

PhD in a relevant field

PharmD

Jobbeschreibung

Company 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, LinkedIn and Tik Tok.

Company 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, LinkedIn and Tik Tok.

Job Description

Purpose

Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Leads 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. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions. Leads teams within Clinical Pharmacology and Pharmacometrics and accountable for effective performance of the teams.

Responsibilities

Independently 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 impacting multiple complex projects and leads issue resolution. Conducts risk assessments and leads the function 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 expert scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans. Connect scientific, regulatory, and business implications from multiple teams. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.

Responsible for critically 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.

Responsible for leading efforts to develop departmental goals. Makes strategic PK/PD decisions for the department. Provides leadership on strategic clinical pharmacology and drug development.

Manages personnel including development, mentoring, and effective delegation.

Leads teams within department, across Clinical Pharmacology and across functions. Responsible for leadership of cross-functional teams and accountable for effective performance of the team. Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high performing teams.

Qualifications

This is a hybrid opportunity, 3x/week in the Lake County, IL

Qualifications

PhD with typically 9+ years of experience or Pharm D with typically 11+ years of experience in a relevant field, Master's Degree in Science or related field with typically 17+ years of related work, Bachelor's Degree in Science or related field with typically 19+ years or more of related work; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)

Excellent interpersonal skills

Advanced knowledge and experience in multiple therapeutic and/or functional areas

Experience across range of development phases

Recognized as an expert with global knowledge of AbbVie and Pharma drug development processes

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

Demonstrated leadership skills with broad scientific and business-related orientations

Demonstrated project management skills such as scope management, progress tracking/driving as well as people and time management

Key contributor to initiatives and advancement of Clinical Pharmacology

Key Leadership Competencies:

• Knows the business and the cross-functional contributions needed to deliver results
• Manages conflict and difficult conversations in a constructive transparent way
• Develops direct reports and capable successors through coaching, stretch assignments and learning opportunities
• Respectfully provides transparent, accurate and timely feedback to help direct reports improve performance
• Creates an inclusive environment where all direct reports can succeed

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 short-term incentive programs.
• 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