Associate Director, Clinical Pharmacology

Posted Yesterday
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Irvine, CA, USA
Hybrid
Mid level
Healthtech • Pharmaceutical
The Role
Lead clinical pharmacology and PK/PD strategy across phases 1-4, design and interpret PK/PD and population PK analyses, author regulatory documents, represent clinical pharmacology in cross-functional and regulatory meetings, mentor teams, publish and present findings, and support business development due diligence.
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

Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.

Responsibilities

  • Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
  • Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
  • Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.
  • Leads clinical pharmacology and biopharmaceutics meetings, serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, Journal club.
  • Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
  • Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
  • Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
  • Represents Clinical Pharmacology at regulatory meetings.

Qualifications

  • PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 12+ years of experience, Bachelor’s Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
  • Excellent interpersonal skills
  • Ability to interact with functional representatives and KOLs externally and internally and lead team(s)
  • Strategic thinking and enterprise view
  • Proven scientific track record and technical skills to perform the role
  • Key Leadership Competencies:
    • Delivers business results while also positioning AbbVie for long-term success
    • 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
    • Gives full accountability when delegating and accepts full accountability when delegated to by others

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 in relevant field with typically 4+ years of experience (or PharmD 6+, Master's 12+, Bachelor's 14+ as alternative experience pathways)
  • Experience with PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, and drug metabolism/transporters
  • Design and execution of Phase 1-4 clinical pharmacology studies and strategy
  • Experience performing and interpreting population PK and exposure-response analyses
  • Authorship of regulatory documents (protocols, study reports, population PK reports, exposure-response reports, CTDs, label sections, IBs)
  • Proven scientific track record, technical skills in clinical pharmacology and pharmacometrics
  • Leadership and team management experience; ability to lead cross-functional teams and represent Clinical Pharmacology
  • Excellent interpersonal and communication skills; ability to interact with KOLs and external stakeholders
  • Experience authoring scientific publications and presenting at national/international conferences
  • Experience conducting due diligence and representing clinical pharmacology in business development

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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