Associate Director, Clinical Pharmacology

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Translational Pharmacokinetics and Clinical Pharmacology group at AbbVie is seeking for an Associate Director. As a member of multidisciplinary teams, this role 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. The 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 Associate Director of Clinical Pharmacology will also establish innovative modeling approaches to enable translation from animal to human. This individual will need to have a strong background and expertise in pharmacokinetics and biopharmaceutics including IVIVC modeling, PBPK modeling, and exposure-response modeling in drug development. This individual should be comfortable with exploratory analyses and non-conventional modeling beyond systemic drug development including ophthalmology, neurotoxin, and aesthetics/dermatology.

Responsibilities:

• Design and provide scientific oversight of preclinical PK/TK studies and Clinical Pharmacology studies.
• Identify opportunities to apply and develop modeling and simulation strategies across the R&D portfolio, with a focus on ophthalmology, neurotoxin, and aesthetics/dermatology.
• Integrate M&S knowledge to contribute to optimizing clinical pharmacology strategies.
• Analysis of PK/PD data, both clinical and nonclinical, using sophisticated mathematical and statistical modeling and simulation tools to support dose selection, study design and proof-of-concept.
• Identify and monitor vendors and consultants or engage internal resource as appropriate to meet project deliverables.
• 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.
• In collaboration with other stakeholders, conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filing and regulatory correspondences.
• 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.

Required:

• Doctorate (Ph.D. in chemical or biomedical engineering; applied mathematics; quantitative pharmaceutical sciences or a related field), with +5 years of post-graduate work experience or Pharm D with typically 6+ years of experience in a relevant field, or Master s Degree or equivalent education and typically 12+ years of experience, or Bachelor s Degree or equivalent education and typically 14+ years of experience.
• Hands-on experience with relevant modeling software and programming languages including MATLAB/Simbiology, R, Python, WinNonLin/Phoenix, NONMEM, etc.
• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop models.
• Data manipulation and programming skills and ideally with the use of programs such as SAS, R, S+ or similar programs.
• 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).
• 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 or post-doctoral experience in an academic lab focused on training pharmacometricians will also be considered.

Preferred:

• Publication record demonstrating PK/PD or systems modeling examples is highly preferred.
• Experience with development of sustained release formulations and/or biologics.
• Understanding of small or large molecule drug modalities and relevant analytical methods for measuring drug and biomarker levels in preclinical and clinical study samples.

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.

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