Director, Clinical Pharmacology

Posted 2 Days Ago
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North Chicago, IL, USA
Hybrid
161K-305K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead clinical pharmacology, PK/PD and pharmacometrics strategy across multiple development projects. Provide scientific and regulatory consultation, review protocols and submissions, perform due diligence, drive risk assessments and process improvements, and manage/mentor teams to align programs with business and development objectives.
Summary Generated by Built In
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

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

Skills Required

  • PhD with typically 7+ years, PharmD with typically 9+ years, MS with typically 15+ years, or BS with typically 17+ years in relevant field (PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism/transporters)
  • Demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities across multiple projects
  • Scientific project leadership experience (planning, implementation, completion)
  • Knowledge and experience across multiple therapeutic and functional areas and development phases
  • Knowledge of pharma drug development processes (AbbVie experience a plus)
  • Project management skills including scope management, progress tracking, and time management
  • Up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software
  • Excellent interpersonal and cross-functional communication skills; ability to present to senior/executive management and regulatory agencies
  • Experience preparing and reviewing clinical pharmacology regulatory documents and responding to agency comments
  • Ability to conduct due diligence and represent clinical pharmacology on business development teams
  • Experience developing process improvement initiatives
  • People management experience including development, mentoring, and delegation (may manage personnel)

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
  • Parental & Family Support Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
  • Healthcare Strength Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.

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The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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AbbVie Logo AbbVie

Director, Clinical Pharmacology

Healthtech • Pharmaceutical
Hybrid
North Chicago, IL, USA
50000 Employees
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