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About the Role
Conceives, executes, and manages multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial and regulatory goals. Leads PK/PD study proposals and anticipates/evaluates advancements in the field to develop new strategies. Demonstrates a strong track record in Clinical Pharmacology and business objectives, leading multiple projects.
Responsibilities
- Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
- Executes strategy, leads teams, and conducts data analyses and interpretation by providing necessary context.
- Authors regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, investigator brochures, and white papers.
- Leads clinical pharmacology and biopharmaceutics meetings, serves as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team, and presents at departmental and cross-functional teams.
- Drives small teams from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams.
- Authors scientific publications and presents at national and international conferences, interacting with KOLs/external stakeholders.
- Conducts due diligence assessments, summarizes results, and represents CLINICAL PHARMACOLOGY on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Requirements
- 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.
- Proven scientific track record and technical skills to perform the role.
- Delivers business results while also positioning AbbVie for long-term success.
- Persistent and resilient, finds ways to move good ideas forward.
- Acts respectfully yet courageously.
- Connects unrelated concepts, generates original or unique ideas.
- Influences colleagues to achieve cross-functional alignment.
- Gives full accountability when delegating and accepts full accountability when delegated to by others.
Skills
- PK
- PBPK
- PK-PD
- Pharmacometrics
- Systems pharmacology
- Drug metabolism
- Transporters
Experience Level
- 4+ years of experience (PhD)
- 6+ years of experience (Pharm D)
- 12+ years of experience (Master’s Degree)
- 14+ years of experience (Bachelor’s Degree)
Education Level
- PhD
- Pharm D
- Master’s Degree
- Bachelor’s Degree
Salary/Compensations
- USD 141500 - USD 268500 - yearly
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Eligible to participate in our long-term incentive programs.
About the Company
- 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html