Associate Director, Clinical Pharmacology

The Translational Pharmacokinetics and Clinical Pharmacology group at AbbVie is seeking for an Associate Director.  As a member of multidisciplinary teams, this individual will provide project support, informing decision-making in both small molecule and biologics, novel drug delivery platform projects from Discovery to Development to On Market Support.  Scope of work includes preclinical PK/PD, clinical PK/PD, clinical pharmacology (CP), and target engagement strategy for assets in eyecare, aesthetics, and neurotoxin portfolios.  The candidate will also establish innovative modeling approaches to enable translation from animal to human.

This position can be based from the following AbbVie locations: Irvine, CA; Lake County, IL; Madison, NJ. Remote work arrangements will also be considered for experienced candidates.

Responsibilities:

Design and provide scientific oversight of preclinical PK/TK studies and Clinical Pharmacology studies

Conduct data analyses including PK/PKPD analyses, modeling and simulation, literature data analyses

Liaise with research, toxicology, immunology, bioanalytical, clinical development, and regulatory colleagues to generate data and knowledge supporting product development and implementation of translational models

At project level, establish and maintain effective collaborations with key stakeholders to facilitate data integration for biomarker selection, candidate nomination/selection, human dose prediction and FIH study design, and late-stage clinical development dose selection and clinical pharmacology characterization to support registration and product labeling

Participate and present at various departmental and cross functional teams

Author regulatory documents including protocols, study reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents

Maintain awareness of emerging literature and science in PK/Clinical Pharmacology specific to eyecare, aesthetics, and neurotoxin.

Acts as a representative for the company to outside parties and regulatory agencies for AbbVie products. Attends scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge in field of specialization.

Author scientific publications and present at scientific conferences.

Mentor Clinical Pharmacology fellows and interns. 

• 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)
•  Level and compensation will be commensurate with experience
• Hands-on experience with relevant modeling software and programming languages including MATLAB/Simbiology, R, Python, WinNonLin/Phoenix, NONMEM, etc. is desired
• Understanding of small or large molecule drug modalities and relevant analytical methods for measuring drug and biomarker levels in preclinical and clinical study samples is required
• Publication record demonstrating PK/PD or systems modeling examples is highly desired
• Must have strong communication skills and the ability to effectively communicate with both internal and external stakeholders, and to audiences of diverse backgrounds
• Highly motivated, self-driven and results-oriented person, capable of both leading and being lead
• High degree of flexibility in adapting to different projects and personalities as well as excellent networking and relationship-building skills (both internal and external) required
• Passion for data analysis, solving technical problems and applying new technologies to further scientific goals and answer key scientific questions enabling data informed decision-making
• Additional prior experience in an experimental in vitro or in vivo biology field is desired

 

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. 

 

#LI-Hybrid

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.