Job Description

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.