Associate Director, Clinical Pharmacology/Senior Clinical Pharmacologist (Oncology)
AbbVie · CA, US
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About the Role
Conceives, executes, manages, and communicates multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements. Generates new PK/PD study proposals and leads these efforts, anticipating and evaluating advancements, strengths, weaknesses, opportunities, and threats in Clinical Pharmacology and PK/PD to implement new strategies. Demonstrates a strong track record of achieving Clinical Pharmacology and business objectives and leads Clinical Pharmacology/PK/PD aspects of 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 various 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, relevant sections of 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
- PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 8+ years of experience, Bachelor’s Degree or equivalent education and typically 10+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Ability to interact externally and internally and perform in a team setting
- Demonstrates scientific acumen and has technical skills to perform the role
Skills
- PK
- PBPK
- PK-PD
- Pharmacometrics
- Systems pharmacology
- Drug metabolism/Transporters
Experience Level
- Associate Director, Clinical Pharmacology
- Senior Clinical Pharmacologist
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