Full Job Description
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.
Responsibilities
Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
37Executes 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).
37Author 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.
37Leads 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.
37Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
37Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
37Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
37Represents Clinical Pharmacology at regulatory meetings.
Qualifications
37PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Masters Degree or equivalent education and typically 12+ years of experience, Bachelors 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)
37Excellent interpersonal skills
37Ability to interact with functional representatives and KOLs externally and internally and lead team(s)
37Strategic thinking and enterprise view
37Proven scientific track record and technical skills to perform the role
37Key Leadership Competencies:
37 Delivers business results while also positioning AbbVie for long-term success
37 Persistent and resilient finds the way to move good ideas forward
37 Acts respectfully yet courageously
37 Connects unrelated concepts, generates original or unique ideas
37 Influences colleagues to achieve cross-functional alignment
37 Gives full accountability when delegating and accepts full accountability when delegated to by others
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
37The 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 thisposting 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.
37We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
37This 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 Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.