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Associate Director, Clinical Pharmacology /Senior Clinical Pharmacologist (Oncology)

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 XFacebookInstagramYouTubeLinkedIn and Tik Tok.

Job Description

Purpose:

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.

Description:

 

  • 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

*This position is required to sit on-site 3 days / week*

This position can be hired based on the following qualifications below:

Associate Director, Clinical Pharmacology:

  • 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

Senior Clinical Pharmacologist:

  • PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 8+ years of experience, Bachelor’s Degree or equivalent education and typically 10+ 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 externally and internally and perform in a team setting
  • Demonstrates scientific acumen and has technical skills to perform the role
  • Key Leadership Competencies:
    • Persistent and resilient finds the way to move good ideas forward
    • Uses mistakes, failure and reflection as vehicles for learning and improvement
    • Delivers business results while also positioning AbbVie for long-term success
    • Connects unrelated concepts, generates original or unique ideas
    • Influences colleagues to achieve cross-functional alignment

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, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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

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What You Should Know About Associate Director, Clinical Pharmacology /Senior Clinical Pharmacologist (Oncology), AbbVie

Join AbbVie as an Associate Director, Clinical Pharmacology/Senior Clinical Pharmacologist in North Chicago, IL, where you'll be at the forefront of transforming lives through innovative medicines. At AbbVie, our mission is to tackle pressing health challenges and enhance the lives of patients across major therapeutic areas, including oncology. Your role will involve designing and executing comprehensive clinical pharmacology development plans and overseeing Phase 1-4 clinical studies. You'll collaborate closely with multidisciplinary teams, contributing to the strategic design and analysis of studies while creating regulatory documents that shape the landscape of our therapeutic offerings. If you're passionate about leveraging your expertise to anticipate and respond to evolving clinical pharmacology landscapes, this position is tailor-made for you. Not only will you engage in exciting projects that have a substantial impact, but you'll also have the opportunity to represent AbbVie in regulatory meetings and at scientific conferences. We're looking for someone with a strong scientific background and proven leadership skills to unify clinical pharmacology perspectives across teams. If you have a Ph.D. or Pharm.D. and several years of relevant experience, we invite you to apply and help drive our commitment to delivering innovative health solutions.

Frequently Asked Questions (FAQs) for Associate Director, Clinical Pharmacology /Senior Clinical Pharmacologist (Oncology) Role at AbbVie
What are the primary responsibilities of the Associate Director, Clinical Pharmacology at AbbVie?

As the Associate Director, Clinical Pharmacology at AbbVie, you’ll be accountable for designing Phase 1-4 studies and developing comprehensive clinical pharmacology strategies. You will lead multidisciplinary teams, execute data analyses, and draft critical regulatory documents. Your role will involve interfacing with various teams, including presenting at cross-functional meetings and scientific conferences, all aimed at driving AbbVie's research initiatives forward.

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What qualifications are needed for the Senior Clinical Pharmacologist position at AbbVie?

To qualify for the Senior Clinical Pharmacologist position at AbbVie, candidates typically need a Ph.D. with at least two years of experience or a Pharm.D. with relevant qualifications. Demonstrated experience in pharmacokinetics, pharmacodynamics, or related fields is essential. Additionally, excellent interpersonal skills combined with a proven ability to work collaboratively in a team environment are crucial for success in this role.

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What kind of experience is beneficial for the Associate Director role at AbbVie?

Experience in clinical pharmacology, particularly in oncology, is highly beneficial for the Associate Director role at AbbVie. Familiarity with PK/PD modeling, biopharmaceutics, and regulatory documentation is essential, along with a strong scientific track record that demonstrates both leadership capabilities and effective project management skills.

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What does a typical workweek look like for the Associate Director, Clinical Pharmacology at AbbVie?

A typical workweek for the Associate Director, Clinical Pharmacology at AbbVie involves extensive collaboration with scientific teams, leading project discussions, and conducting data analysis. You'll also engage with stakeholders to align on pharmacological strategies and contribute to regulatory discussions, while balancing time spent on project development and presentations at various forums.

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How does AbbVie support the professional development of Clinical Pharmacologists?

AbbVie is committed to the professional development of its Clinical Pharmacologists through various initiatives, including access to continuous learning opportunities, participation in conferences, and the chance to lead innovative projects that influence the direction of clinical research. Employees are encouraged to expand their expertise and contribute to groundbreaking solutions in pharmacology.

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Common Interview Questions for Associate Director, Clinical Pharmacology /Senior Clinical Pharmacologist (Oncology)
Can you explain your experience with pharmacokinetics and pharmacodynamics?

When discussing your experience with pharmacokinetics and pharmacodynamics, focus on specific projects where you applied these principles. Describe any relevant modeling approaches you utilized, the outcomes of your studies, and how these experiences have shaped your understanding of drug interactions and efficacy, particularly in oncology settings.

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How do you approach designing clinical pharmacology studies?

In response to this question, outline your strategic approach to designing studies, including defining objectives, selecting appropriate methodologies, and ensuring regulatory compliance. Share examples from your past experiences where you’ve successfully implemented these strategies, particularly highlighting any innovative solutions or challenges you overcame.

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What is your experience with creating regulatory documents?

Detail your experience with creating regulatory documents by sharing specific examples of types you've authored, such as protocols, reports, or submission documents. Emphasize your attention to detail and collaborative approach in gathering necessary data from interdisciplinary team members.

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How do you stay updated with advancements in clinical pharmacology?

Discuss the methods you utilize to stay updated in clinical pharmacology, such as attending conferences, reading relevant journals, or engaging with professional networks. Highlight any strategies you employ to apply this knowledge practically in your role at AbbVie or other organizations.

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Can you describe your experience working in cross-functional teams?

Emphasize your collaborative skills by sharing experiences working in cross-functional teams. Discuss your role, how you facilitated communication, and notable outcomes from these collaborations. Illustrate the importance of teamwork in achieving shared objectives, especially in clinical research contexts.

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What strategies do you use for effective data analysis in clinical studies?

Articulate your approach to data analysis by discussing specific techniques or software you employ. Highlight experiences where your analysis led to critical insights or changes in study direction, demonstrating your analytical skills and strategic thinking.

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How do you handle challenges during clinical trials?

Explain your problem-solving strategies when faced with challenges in clinical trials. Provide examples of issues you've encountered and the methods you used to navigate them, showcasing your resilience and ability to adapt to changing circumstances.

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Can you give an example of a successful project you led?

Share a detailed example of a project where you took a lead role. Highlight the objectives, challenges faced, your strategies for overcoming them, and the successful outcomes that benefited the organization, particularly within a clinical pharmacology context.

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What is your understanding of the regulatory landscape affecting clinical pharmacology?

Discuss your understanding of the regulatory landscape by mentioning key regulations relevant to clinical pharmacology. Share insights gained from experiences with regulatory submissions or interactions, emphasizing your proficiency in navigating these requirements in research settings.

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How do you prioritize tasks in a fast-paced clinical environment?

Describe your prioritization strategies by providing examples of how you have managed competing deadlines in a clinical environment. Illustrate your organizational skills and ability to focus on high-impact tasks that align with project objectives.

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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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DATE POSTED
March 19, 2025

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