Associate Director, Clinical Pharmacology at AbbVie · LumiJobs

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.
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

Associate Director, Clinical Pharmacology

Responsibilities

Qualification

Required

Benefits

Company

AbbVie

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