Director, Clinical Pharmacology (Immunology)

AbbVie Inc.; Chicago (IL); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Vacation, Holidays, Sick leave

Medical, dental, vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie in the United States is seeking a senior Clinical Pharmacology leader to communicate strategy to senior management and regulators, and to support drug development plans. You will liaison with multiple departments and may lead teams within Clinical Pharmacology and Pharmacometrics.

The role requires extensive experience in PK/PD, regulatory writing, and strategic decision-making, with a track record of leadership across projects.

Qualifications

• PhD with typically 7+ years of experience in a relevant field, or PharmD with 9+ years, MS with 15+ years, or BS with 17+ years (as stated).
• Strong leadership capabilities and scientific project leadership experience.
• Experience across multiple therapeutic or functional development areas.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects.
• Identifies issues and helps with issue resolution; conducts risk assessments.
• Provides timelines and negotiates project deliverables across functions.
• Provides scientific and strategic consultation to R&D, Regulatory, and management.
• Responsible for evaluating technical/scientific aspects and leading regulatory documents.
• Independently conducts due diligence assessments and represents CP on BD teams.
• Identifies/Develops process improvements and secures management sponsorship.
• Contributes to departmental goals and PK/PD strategy.
• Maintains knowledge of PK/PD data analysis, modeling, and software.
• May manage personnel including development and mentoring.

Skills

Leadership in PK/PD

Scientific project leadership

Regulatory liaison

Project management

Cross-functional collaboration

Education

PhD in a relevant field

PharmD with 9+ years of experience

MS or equivalent education with 15+ years

BS or equivalent education with 17+ years

Tools

PK/PD modeling software

Job description

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

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

• 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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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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