Director, Clinical Pharmacology

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 183,000 - 305,000; Full time

Job summary

AbbVie is seeking a senior leader in Clinical Pharmacology to guide drug development strategies and communicate scientific insights to senior management and regulators. You will lead PK/PD activities across major projects, liaise with R&D, Regulatory, and cross-functional teams, and shape lifecycle strategies while ensuring timely, high-quality deliverables.

The role requires a PhD or PharmD with extensive experience in PK/PD, pharmacometrics, and drug development, with proven leadership and

Qualifications

• PhD/PharmD with extensive experience in PK/PD, Pharmacometrics or systems pharmacology.
• Experience across drug development phases and multiple therapeutic areas.
• Demonstrated leadership in PK/PD, Biopharmaceutics, and pharmacometrics across projects.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and major projects.
• Assists in selection of action plans aligning with drug development objectives.
• Develops contingency plans and manages risks to keep projects on track.
• Provides scientific/strategic consultation to R&D, Regulatory and management.
• Reviews clinical protocols and reports for regulatory filings; writes regulatory documents.

Skills

Interpersonal skills

Therapeutic experience

Development phases

PK/PD leadership

Pharmacometrics

Project management

Scientific leadership

Cross-functional collaboration

Regulatory consultation

Education

PhD

PharmD

MS or equivalent

BS or equivalent

Tools

PK/PD modeling software

Biopharmaceutics

Job description

• Compensation: USD 160,500 - USD 305,000 - yearly

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 orlocal law:

• 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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